Trial Outcomes & Findings for Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (NCT NCT03581123)
NCT ID: NCT03581123
Last Updated: 2025-10-16
Results Overview
Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible). Missing weekly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline pain intensity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1000 participants
Primary outcome timeframe
Average over weeks 1-52
Results posted on
2025-10-16
Participant Flow
Participant milestones
| Measure |
Supported Self-Management (SSM)
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Treatment Adherence Assessment
STARTED
|
305
|
201
|
193
|
301
|
|
Treatment Adherence Assessment
Adherent to Treatment
|
271
|
168
|
156
|
290
|
|
Treatment Adherence Assessment
Non-adherent, Due to COVID
|
4
|
19
|
18
|
2
|
|
Treatment Adherence Assessment
Non-adherent, Not Due to COVID
|
30
|
14
|
19
|
9
|
|
Treatment Adherence Assessment
COMPLETED
|
305
|
201
|
193
|
301
|
|
Treatment Adherence Assessment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
2-month Follow-up
STARTED
|
305
|
201
|
193
|
301
|
|
2-month Follow-up
Completed Follow-up
|
290
|
195
|
182
|
292
|
|
2-month Follow-up
Missed Follow-up (Timed Out)
|
2
|
1
|
3
|
3
|
|
2-month Follow-up
COMPLETED
|
292
|
196
|
185
|
295
|
|
2-month Follow-up
NOT COMPLETED
|
13
|
5
|
8
|
6
|
|
6-Month Follow-up
STARTED
|
292
|
196
|
185
|
295
|
|
6-Month Follow-up
Completed Follow-up
|
282
|
188
|
180
|
284
|
|
6-Month Follow-up
Missed Follow-up (Timed Out)
|
5
|
5
|
3
|
8
|
|
6-Month Follow-up
COMPLETED
|
287
|
193
|
183
|
292
|
|
6-Month Follow-up
NOT COMPLETED
|
5
|
3
|
2
|
3
|
|
12-Month Follow-up
STARTED
|
287
|
193
|
183
|
292
|
|
12-Month Follow-up
Completed Follow-up
|
280
|
187
|
178
|
283
|
|
12-Month Follow-up
Missed Follow-up (Timed Out)
|
3
|
3
|
1
|
4
|
|
12-Month Follow-up
COMPLETED
|
283
|
190
|
179
|
287
|
|
12-Month Follow-up
NOT COMPLETED
|
4
|
3
|
4
|
5
|
Reasons for withdrawal
| Measure |
Supported Self-Management (SSM)
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
2-month Follow-up
Withdrawal by Subject
|
5
|
4
|
6
|
4
|
|
2-month Follow-up
Lost to Follow-up
|
8
|
1
|
2
|
2
|
|
6-Month Follow-up
Withdrawal by Subject
|
2
|
0
|
1
|
2
|
|
6-Month Follow-up
Lost to Follow-up
|
3
|
3
|
1
|
1
|
|
12-Month Follow-up
Lost to Follow-up
|
4
|
3
|
4
|
5
|
Baseline Characteristics
Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain
Baseline characteristics by cohort
| Measure |
Total
n=1000 Participants
Total of all reporting groups
|
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47 Years
STANDARD_DEVIATION 16 • n=21 Participants
|
47 Years
STANDARD_DEVIATION 15 • n=5 Participants
|
48 Years
STANDARD_DEVIATION 16 • n=7 Participants
|
47 Years
STANDARD_DEVIATION 17 • n=5 Participants
|
47 Years
STANDARD_DEVIATION 16 • n=4 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
577 Participants
n=21 Participants
|
175 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
410 Participants
n=21 Participants
|
124 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
12 Participants
n=21 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Unknown/not reported
|
1 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=21 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
949 Participants
n=21 Participants
|
297 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
283 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=21 Participants
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
66 Participants
n=21 Participants
|
25 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
835 Participants
n=21 Participants
|
258 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
28 Participants
n=21 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Site
Minneapolis
|
582 Participants
n=21 Participants
|
185 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Site
Pittsburgh
|
418 Participants
n=21 Participants
|
120 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
STarT Back Risk Category
Medium
|
699 Participants
n=21 Participants
|
212 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
STarT Back Risk Category
High
|
301 Participants
n=21 Participants
|
93 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Recruitment Time Period
Pre-COVID
|
186 Participants
n=21 Participants
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Recruitment Time Period
COVID
|
211 Participants
n=21 Participants
|
106 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Recruitment Time Period
Post-COVID
|
603 Participants
n=21 Participants
|
153 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Pain intensity
|
5.4 score on a scale
STANDARD_DEVIATION 1.6 • n=21 Participants
|
5.5 score on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
5.4 score on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
5.4 score on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
5.4 score on a scale
STANDARD_DEVIATION 1.6 • n=4 Participants
|
|
Disability
|
11.2 score on a scale
STANDARD_DEVIATION 4.7 • n=21 Participants
|
11.6 score on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
10.9 score on a scale
STANDARD_DEVIATION 4.6 • n=7 Participants
|
10.8 score on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
11.4 score on a scale
STANDARD_DEVIATION 4.5 • n=4 Participants
|
|
Low Back Pain Impact Score
|
25.6 score on a scale
STANDARD_DEVIATION 6.7 • n=21 Participants
|
25.9 score on a scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
24.6 score on a scale
STANDARD_DEVIATION 6.6 • n=7 Participants
|
25.2 score on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
26.1 score on a scale
STANDARD_DEVIATION 6.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Average over weeks 1-52Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible). Missing weekly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline pain intensity.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Pain Intensity
|
2.8 score on a scale
Standard Error 0.1
|
3.0 score on a scale
Standard Error 0.1
|
2.8 score on a scale
Standard Error 0.1
|
3.0 score on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Average over months 1-12Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities. Score ranges from 0 to 24 with higher values indicating more disability. Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline RMDQ.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Disability
|
4.7 score on a scale
Standard Error 0.2
|
5.5 score on a scale
Standard Error 0.3
|
4.8 score on a scale
Standard Error 0.3
|
5.9 score on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Average over months 10 -12Measured by the LBP impact scale, which includes measures of pain intensity, pain interference, and physical function from the PROMIS-29 Profile v2.0. The scale ranges from 8 (least impact) to 50 (greatest impact). Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline LBP impact score.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Low Back Pain (LBP) That is Impactful
|
15.3 score on a scale
Standard Error 0.4
|
16.7 score on a scale
Standard Error 0.5
|
15.7 score on a scale
Standard Error 0.5
|
17.0 score on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: 6 monthsMeasured by the proportion of patients with scores of 0 on the 0-10 pain numeric rating scale (NRS) and a score of less than or equal to 2 on the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=282 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=186 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=177 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=284 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Recovery From Acute/Sub-acute Low Back Pain
|
56 Participants
|
29 Participants
|
33 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-52Population: Only participants with at least 35 weeks of follow-up between weeks 1 and 52 are included in the analysis.
Participants report the number of days that low back pain has been a problem in the past 7 days for 52 weeks. This measure is the percent of days that low back pain has been a problem. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=273 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=185 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=173 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=281 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Low Back Pain Frequency - Percent of Days Over 12 Months
|
39 Percent of days
Interval 36.0 to 43.0
|
44 Percent of days
Interval 40.0 to 48.0
|
38 Percent of days
Interval 34.0 to 42.0
|
46 Percent of days
Interval 42.0 to 49.0
|
SECONDARY outcome
Timeframe: Months 1-12Population: Only participants with at least 8 months of follow-up between months 1 and 12 on this outcome are included in the analysis.
Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures. This is a binary indicator of any care from providers outside the study for low back pain.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=277 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=187 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=178 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=283 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Number of Participants Who Received Care For Low Back Pain
|
82 Participants
|
67 Participants
|
53 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: Months 4-12Population: Only participants with at least 6 months of follow-up between months 4 and 12 are included in the analysis.
Over the counter and prescription medication use for low back pain. Since the MC arm intervention includes medications, only months 4-12 (i.e. after the intervention) are considered for this outcome. The measure is the percent of months 4-12 in which medication was used for low back pain. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=277 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=188 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=179 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=283 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Medication Use - Percent of Months 4-12
|
37 Percent of months 4-12
Interval 33.0 to 42.0
|
40 Percent of months 4-12
Interval 34.0 to 46.0
|
37 Percent of months 4-12
Interval 31.0 to 43.0
|
54 Percent of months 4-12
Interval 50.0 to 58.0
|
SECONDARY outcome
Timeframe: Months 1-12Population: Only participants with at least 8 months of follow-up between months 1 and 12 are included in the analysis.
Participants indicated in monthly follow-ups if they were bothered by low back pain over the last month. This measure is the percent of months that participants were bothered by low back pain at work. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=279 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=189 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=179 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=285 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Bothered by Low Back Pain at Work - Percent of Months
|
43 Percent of months
Interval 39.0 to 47.0
|
45 Percent of months
Interval 40.0 to 51.0
|
43 Percent of months
Interval 38.0 to 48.0
|
51 Percent of months
Interval 47.0 to 55.0
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=290 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=193 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=183 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=291 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Global Improvement
|
6.2 score on a scale
Standard Deviation 1.2
|
6.3 score on a scale
Standard Deviation 1.0
|
6.4 score on a scale
Standard Deviation 1.1
|
5.7 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=281 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=187 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=178 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=281 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Global Improvement
|
6.1 score on a scale
Standard Deviation 1.4
|
6.0 score on a scale
Standard Deviation 1.3
|
6.3 score on a scale
Standard Deviation 1.4
|
5.5 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=279 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=187 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=177 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=280 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Global Improvement
|
6.2 score on a scale
Standard Deviation 1.3
|
5.8 score on a scale
Standard Deviation 1.6
|
6.3 score on a scale
Standard Deviation 1.4
|
5.5 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: The counts above are for participants that completed the satisfaction question at the 2-month time point. The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=289 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=193 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=183 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=291 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient Satisfaction With Treatment
|
4.9 score on a scale
Standard Deviation 1.0
|
5.0 score on a scale
Standard Deviation 0.9
|
5.2 score on a scale
Standard Deviation 0.9
|
4.2 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=281 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=188 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=177 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=281 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient Satisfaction With Treatment
|
4.8 score on a scale
Standard Deviation 1.0
|
4.8 score on a scale
Standard Deviation 1.1
|
5.1 score on a scale
Standard Deviation 0.9
|
4.1 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=279 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=183 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=177 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=281 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient Satisfaction With Treatment
|
4.7 score on a scale
Standard Deviation 1.1
|
4.6 score on a scale
Standard Deviation 1.1
|
5.1 score on a scale
Standard Deviation 1.0
|
4.0 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 6 monthsMeasured by the proportion of patients in each group meeting the definition by the NIH Task Force on Research Standards for Chronic LBP (i.e., ongoing LBP on ≥50% of days over past 6 months).
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=280 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=186 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=178 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=279 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Chronic Low Back Pain (LBP)
|
119 Participants
|
81 Participants
|
78 Participants
|
154 Participants
|
SECONDARY outcome
Timeframe: 12 monthsMeasured by the proportion of patients in each group meeting the definition by the NIH Task Force on Research Standards for Chronic LBP (i.e., ongoing LBP on ≥50% of days over past 6 months).
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=277 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=185 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=177 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=282 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Chronic Low Back Pain (LBP)
|
93 Participants
|
93 Participants
|
68 Participants
|
151 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
Assessed using "how often has low back pain interfered with your ability to do regular activities over the past 6 months?" on a 3-item scale (less than half the days in the past 6 months, at least half the days in the past 6 months, every day or nearly every day in the past 6 months). Here we dichotomize to "at least half the days in the past 6 months" or more.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=279 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=185 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=179 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=282 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Number of Participants Who Reported Chronic Interference With Daily Activities
|
57 Participants
|
41 Participants
|
38 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
Assessed using "how often has low back pain interfered with your ability to do regular activities over the past 6 months?" on a 3-item scale (less than half the days in the past 6 months, at least half the days in the past 6 months, every day or nearly every day in the past 6 months). Here we dichotomize to "at least half the days in the past 6 months" or more.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=278 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=187 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=177 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=281 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Number of Participants Who Reported Chronic Interference With Daily Activities
|
41 Participants
|
36 Participants
|
36 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Unlike outcomes collected via surveys, this outcome required an in-person meeting or teleconference. It was frequently difficult to schedule within the outcome window and thus has lower follow-up than survey outcomes.
Measured by a blinded examiner, in seconds, the time taken by a person to stand up, walk a distance of 10 feet, turn, walk back to the chair and sit down again.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=243 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=167 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=152 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=242 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Timed Up and Go Test
|
9.5 seconds
Standard Deviation 2.0
|
9.5 seconds
Standard Deviation 2.3
|
9.5 seconds
Standard Deviation 3.0
|
10.0 seconds
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Unlike outcomes collected via surveys, this outcome required an in-person meeting or teleconference. It was frequently difficult to schedule within the outcome window and thus has lower follow-up than survey outcomes. Measure was not collected in the UG3 phase of the study (November 2018 through April 2019).
Measured by a blinded examiner, in seconds, the amount of time a person requires to stand up and sit down from a chair 5 times without using their arms
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=223 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=146 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=132 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=223 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Sit-to-stand
|
10.5 seconds
Standard Deviation 2.8
|
11.4 seconds
Standard Deviation 3.3
|
10.9 seconds
Standard Deviation 2.9
|
10.9 seconds
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Unlike outcomes collected via surveys, this outcome required an in-person meeting or teleconference. It was frequently difficult to schedule within the outcome window and thus has lower follow-up than survey outcomes.
Measured by a blinded examiner on a scale from 0-3, with 0 being can easily grab the toes with the fingertips of both hands and 3 being can hardly, if at all, reach as far as to the malleoli. Each leg is scored separately with the greater leg score serving as the overall score.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=237 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=166 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=152 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=244 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
The Sock Test
0: Patient can easily reach and grab toes with fingertips.
|
112 Participants
|
65 Participants
|
53 Participants
|
114 Participants
|
|
The Sock Test
1: Patient can reach toes with effort.
|
28 Participants
|
15 Participants
|
17 Participants
|
30 Participants
|
|
The Sock Test
2: Patient can reach beyond the malleoli but cannot reach toes.
|
20 Participants
|
23 Participants
|
28 Participants
|
25 Participants
|
|
The Sock Test
3: Patient has difficulty reaching even the malleoli.
|
77 Participants
|
63 Participants
|
54 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
Assessed using 8 different diagrams describing back pain change over the last 12 months
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=277 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=186 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=178 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=282 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Visual Trajectory for Pain
(a) A single episode with no other major episode of back pain
|
18 Participants
|
6 Participants
|
13 Participants
|
15 Participants
|
|
Visual Trajectory for Pain
(b) A few episodes of back pain, with mostly pain-free periods in between
|
103 Participants
|
53 Participants
|
51 Participants
|
65 Participants
|
|
Visual Trajectory for Pain
(c) Some back pain most of the time, and a few episodes of severe pain
|
72 Participants
|
58 Participants
|
56 Participants
|
99 Participants
|
|
Visual Trajectory for Pain
(d) Pain that goes up and down all the time, with episodes of severe back pain
|
26 Participants
|
25 Participants
|
16 Participants
|
51 Participants
|
|
Visual Trajectory for Pain
(e) Severe back pain all or nearly all of the time
|
2 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
|
Visual Trajectory for Pain
(f) Back pain that has got gradually worse
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Visual Trajectory for Pain
(g) Back pain that has improved gradually
|
38 Participants
|
28 Participants
|
28 Participants
|
33 Participants
|
|
Visual Trajectory for Pain
(h) No back pain, or only the odd day with mild pain
|
16 Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Unlike outcomes collected via surveys, this outcome required an in-person meeting or teleconference. It was frequently difficult to schedule within the outcome window and thus has lower follow-up than survey outcomes.
Measured by a blinded examiner who will classify the participant's spinal disorder as 0) no pain; 1) pain without radiation; 2) pain with radiation to the proximal extremity; 3) pain with radiation to the distal extremity; 4) pain with radiation to the extremity and neurologic signs.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=248 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=167 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=155 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=253 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Quebec Task Force
0: No pain
|
70 Participants
|
38 Participants
|
32 Participants
|
59 Participants
|
|
Quebec Task Force
1: Pain without radiation
|
150 Participants
|
106 Participants
|
100 Participants
|
163 Participants
|
|
Quebec Task Force
2: Pain with radiation to extremity, proximally
|
19 Participants
|
10 Participants
|
11 Participants
|
13 Participants
|
|
Quebec Task Force
3: Pain with radiation to extremity, distally
|
8 Participants
|
13 Participants
|
10 Participants
|
13 Participants
|
|
Quebec Task Force
4: Pain with radiation to lower limb with neurologic signs
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and 2, 6, and 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
The PROMIS depression scale consists of 4 questions related to depression over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 41.0 - 79.3. Higher scores indicate greater depression. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression
Baseline
|
50.6 T-Score
Standard Deviation 7.2
|
50.2 T-Score
Standard Deviation 7.4
|
50.8 T-Score
Standard Deviation 7.3
|
50.8 T-Score
Standard Deviation 8.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression
2-month
|
49.6 T-Score
Standard Deviation 7.6
|
49.0 T-Score
Standard Deviation 7.9
|
49.7 T-Score
Standard Deviation 8.2
|
50.4 T-Score
Standard Deviation 8.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression
6-month
|
48.2 T-Score
Standard Deviation 8.1
|
48.2 T-Score
Standard Deviation 7.8
|
48.6 T-Score
Standard Deviation 8.4
|
49.6 T-Score
Standard Deviation 8.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression
12-month
|
48.2 T-Score
Standard Deviation 8.0
|
47.8 T-Score
Standard Deviation 8.2
|
48.2 T-Score
Standard Deviation 8.2
|
49.0 T-Score
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline and 2, 6, and 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
The PROMIS physical function scale consists of 4 questions about ability to perform tasks of daily living. The raw score is converted to the T-Score that is reported here. The range of possible scores is 22.6 - 57.0. Higher scores indicate greater physical function. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Baseline
|
40.7 T-Score
Standard Deviation 4.6
|
21.7 T-Score
Standard Deviation 5.7
|
41.3 T-Score
Standard Deviation 5.5
|
40.5 T-Score
Standard Deviation 4.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
2-month
|
46.0 T-Score
Standard Deviation 6.8
|
46.8 T-Score
Standard Deviation 7.3
|
46.4 T-Score
Standard Deviation 7.0
|
44.8 T-Score
Standard Deviation 6.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
6-month
|
48.0 T-Score
Standard Deviation 7.5
|
47.3 T-Score
Standard Deviation 7.4
|
47.5 T-Score
Standard Deviation 8.1
|
46.3 T-Score
Standard Deviation 7.6
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
12-month
|
48.5 T-Score
Standard Deviation 7.5
|
47.7 T-Score
Standard Deviation 7.7
|
48.6 T-Score
Standard Deviation 7.7
|
46.6 T-Score
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Baseline and 2, 6, and 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
The PROMIS anxiety scale consists of 4 questions related to anxiety over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 40.3 - 81.4. Higher scores indicate greater anxiety. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety
12-month
|
48.9 T-Score
Standard Deviation 9.1
|
48.7 T-Score
Standard Deviation 8.9
|
49.1 T-Score
Standard Deviation 9.5
|
50.1 T-Score
Standard Deviation 9.8
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety
Baseline
|
53.5 T-Score
Standard Deviation 8.2
|
53.6 T-Score
Standard Deviation 7.9
|
54.2 T-Score
Standard Deviation 7.6
|
53.8 T-Score
Standard Deviation 8.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety
2-month
|
51.7 T-Score
Standard Deviation 8.0
|
51.2 T-Score
Standard Deviation 8.2
|
52.6 T-Score
Standard Deviation 8.3
|
52.6 T-Score
Standard Deviation 8.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety
6-month
|
49.4 T-Score
Standard Deviation 8.9
|
49.2 T-Score
Standard Deviation 9.2
|
50.6 T-Score
Standard Deviation 9.7
|
50.3 T-Score
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Baseline and 2, 6, and 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
The PROMIS fatigue scale consists of 4 questions related to fatigue over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 33.7 - 75.8. Higher scores indicate greater fatigue. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue
Baseline
|
55.2 T-Score
Standard Deviation 8.1
|
54.3 T-Score
Standard Deviation 8.1
|
54.8 T-Score
Standard Deviation 8.0
|
55.2 T-Score
Standard Deviation 8.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue
2-month
|
52.4 T-Score
Standard Deviation 8.5
|
51.2 T-Score
Standard Deviation 8.0
|
51.8 T-Score
Standard Deviation 8.4
|
53.8 T-Score
Standard Deviation 9.2
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue
6-month
|
51.3 T-Score
Standard Deviation 9.7
|
50.8 T-Score
Standard Deviation 9.7
|
50.4 T-Score
Standard Deviation 10.1
|
52.2 T-Score
Standard Deviation 10.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue
12-month
|
50.8 T-Score
Standard Deviation 10.1
|
50.6 T-Score
Standard Deviation 10.1
|
50.0 T-Score
Standard Deviation 10.2
|
52.3 T-Score
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline and 2, 6, and 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
The PROMIS sleep disturbance scale consists of 4 questions related to sleep disturbance over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 32.0 - 73.3. Higher scores indicate greater sleep disturbance. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance
Baseline
|
52.0 T-Score
Standard Deviation 3.0
|
51.8 T-Score
Standard Deviation 3.4
|
52.0 T-Score
Standard Deviation 3.5
|
52.1 T-Score
Standard Deviation 3.1
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance
2-month
|
52.6 T-Score
Standard Deviation 3.1
|
52.2 T-Score
Standard Deviation 2.9
|
52.1 T-Score
Standard Deviation 3.8
|
52.2 T-Score
Standard Deviation 3.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance
6-month
|
52.2 T-Score
Standard Deviation 3.6
|
51.8 T-Score
Standard Deviation 3.7
|
52.1 T-Score
Standard Deviation 3.5
|
51.9 T-Score
Standard Deviation 3.4
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance
12-month
|
52.2 T-Score
Standard Deviation 3.0
|
52.1 T-Score
Standard Deviation 3.3
|
51.7 T-Score
Standard Deviation 3.6
|
51.7 T-Score
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline and 2, 6, and 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
The PROMIS participation scale consists of 4 questions related to participation in social activities. The raw score is converted to the T-Score that is reported here. The range of possible scores is 27.5 - 64.2. Higher scores indicate greater ability to participate in social activities. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation
Baseline
|
46.8 T-Score
Standard Deviation 6.1
|
47.7 T-Score
Standard Deviation 6.7
|
47.7 T-Score
Standard Deviation 7.2
|
46.6 T-Score
Standard Deviation 6.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation
2-month
|
53.2 T-Score
Standard Deviation 7.6
|
53.5 T-Score
Standard Deviation 7.4
|
52.9 T-Score
Standard Deviation 7.7
|
52.1 T-Score
Standard Deviation 8.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation
6-month
|
54.8 T-Score
Standard Deviation 7.9
|
54.5 T-Score
Standard Deviation 8.5
|
55.0 T-Score
Standard Deviation 8.7
|
53.5 T-Score
Standard Deviation 8.4
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation
12-month
|
55.2 T-Score
Standard Deviation 8.0
|
54.7 T-Score
Standard Deviation 8.4
|
55.8 T-Score
Standard Deviation 8.4
|
54.1 T-Score
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline and 2, 6, and 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables.
The PROMIS participation scale consists of 4 questions related to pain interference in the last 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 41.6 - 75.6. Higher scores indicate greater pain interference. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=305 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=201 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=193 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=301 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference
Baseline
|
60.3 T-Score
Standard Deviation 5.0
|
59.2 T-Score
Standard Deviation 5.4
|
59.9 T-Score
Standard Deviation 5.3
|
60.3 T-Score
Standard Deviation 5.2
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference
2-month
|
52.9 T-Score
Standard Deviation 7.0
|
52.0 T-Score
Standard Deviation 7.3
|
52.4 T-Score
Standard Deviation 7.3
|
53.9 T-Score
Standard Deviation 7.8
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference
6-month
|
51.4 T-Score
Standard Deviation 7.9
|
51.5 T-Score
Standard Deviation 7.6
|
51.2 T-Score
Standard Deviation 8.0
|
52.7 T-Score
Standard Deviation 8.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference
12-month
|
50.3 T-Score
Standard Deviation 8.4
|
51.0 T-Score
Standard Deviation 7.9
|
50.6 T-Score
Standard Deviation 7.9
|
52.4 T-Score
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts may differ somewhat from the Participant Flow tables.
The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4).
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=289 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=194 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=182 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=291 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
STarT Back Risk Classification
Low risk
|
238 Participants
|
164 Participants
|
160 Participants
|
226 Participants
|
|
STarT Back Risk Classification
Medium risk
|
45 Participants
|
28 Participants
|
19 Participants
|
46 Participants
|
|
STarT Back Risk Classification
High risk
|
6 Participants
|
2 Participants
|
3 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts may differ somewhat from the Participant Flow tables.
The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4).
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=281 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=186 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=179 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=283 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
STarT Back Risk Classification
Low risk
|
253 Participants
|
156 Participants
|
147 Participants
|
214 Participants
|
|
STarT Back Risk Classification
Medium risk
|
23 Participants
|
24 Participants
|
27 Participants
|
55 Participants
|
|
STarT Back Risk Classification
High risk
|
5 Participants
|
6 Participants
|
5 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts may differ somewhat from the Participant Flow tables.
The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4).
Outcome measures
| Measure |
Supported Self-Management (SSM)
n=280 Participants
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=186 Participants
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=178 Participants
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=279 Participants
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
STarT Back Risk Classification
Low risk
|
243 Participants
|
158 Participants
|
157 Participants
|
226 Participants
|
|
STarT Back Risk Classification
Medium risk
|
34 Participants
|
23 Participants
|
18 Participants
|
39 Participants
|
|
STarT Back Risk Classification
High risk
|
3 Participants
|
5 Participants
|
3 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2, 6, 12 monthsUsing a 10-100 numerical rating scale (10=very uncertain, 100 = very certain), self-efficacy is measured with the 22-item Chronic Pain Self-Efficacy Scale adapted for acute/sub-acute pain. This is a psychosocial mediating measure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2, 6, 12 monthsMeasured using the 13-item Pain Catastrophizing Scale; it uses a 5-item point scale (0=not at all, 4 all the time). This is a psychosocial mediating measure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2, 6, 12 monthsMeasured using the 11-item Tampa Scale for Kinesiophobia demonstrated to have internal consistency, responsiveness and validity similar to the original 17-item instrument. A four-item scale is used (strongly disagree to strongly agree). This is a psychosocial mediating measure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2, 6, 12 monthsMeasured using an adapted version of the 28-item Brief Coping Orientation to Problems Experienced (COPE) instrument on a 4 point scale (I haven't been doing this at all to I've been doing this a lot). This is a psychosocial mediating measure.
Outcome measures
Outcome data not reported
Adverse Events
Supported Self-Management (SSM)
Serious events: 27 serious events
Other events: 93 other events
Deaths: 0 deaths
Spinal Manipulation Therapy (SMT)
Serious events: 13 serious events
Other events: 63 other events
Deaths: 0 deaths
Combined SSM/SMT
Serious events: 22 serious events
Other events: 63 other events
Deaths: 0 deaths
Medical Care (MC)
Serious events: 22 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Supported Self-Management (SSM)
n=298 participants at risk
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=198 participants at risk
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=190 participants at risk
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=296 participants at risk
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Lumbar back-related procedure
|
0.67%
2/298 • Number of events 2 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
1.1%
2/190 • Number of events 2 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
1.0%
3/296 • Number of events 3 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Surgical and medical procedures
Other surgical/medical procedure
|
2.0%
6/298 • Number of events 6 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
3.5%
7/198 • Number of events 8 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
3.2%
6/190 • Number of events 8 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
2.4%
7/296 • Number of events 9 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.51%
1/198 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.34%
1/296 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Injury, poisoning and procedural complications
Fall or accident
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.51%
1/198 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
1.0%
3/296 • Number of events 3 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Infections and infestations
COVID
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Infections and infestations
Non-COVID infection
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.51%
1/198 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.68%
2/296 • Number of events 2 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.34%
1/296 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.51%
1/198 • Number of events 2 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Psychiatric disorders
Inpatient mental health visit
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.51%
1/198 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Cardiac disorders
Cardiac problems
|
0.67%
2/298 • Number of events 2 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.51%
1/198 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
1.6%
3/190 • Number of events 3 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
1.4%
4/296 • Number of events 4 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Endocrine disorders
Diabetes complications
|
0.67%
2/298 • Number of events 2 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Gastrointestinal disorders
Gastrointestinal issues
|
1.3%
4/298 • Number of events 4 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
1.1%
2/190 • Number of events 3 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.34%
1/296 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory issue
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
1.1%
2/190 • Number of events 2 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancers
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Nervous system disorders
Nervous system problem
|
1.0%
3/298 • Number of events 3 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.51%
1/198 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Ear and labyrinth disorders
Severe vertigo
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Eye disorders
Diabetic retinopathy
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
General disorders
Fluid retention in abdomen and lungs
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.34%
1/296 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Hepatobiliary disorders
Jaundice from gallstones
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Immune system disorders
Anaphylaxis from known allergy
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.34%
1/296 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Investigations
Inpatient diagnostic visit
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Metabolism and nutrition disorders
Malnutrition due to anorexia nervosa
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.34%
1/296 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Musculoskeletal and connective tissue disorders
Thumb pain/weakness
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.34%
1/296 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Reproductive system and breast disorders
Uterine blood clot
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/190 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Vascular disorders
Blood clot in lung
|
0.00%
0/298 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
General disorders
Hospitalization without additional information
|
0.34%
1/298 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/198 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.53%
1/190 • Number of events 1 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
0.00%
0/296 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
Other adverse events
| Measure |
Supported Self-Management (SSM)
n=298 participants at risk
Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
|
Spinal Manipulation Therapy (SMT)
n=198 participants at risk
Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
|
Combined SSM/SMT
n=190 participants at risk
Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment.
|
Medical Care (MC)
n=296 participants at risk
Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
23/298 • Number of events 25 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
7.6%
15/198 • Number of events 17 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
10.0%
19/190 • Number of events 23 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
14.2%
42/296 • Number of events 52 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Infections and infestations
COVID
|
12.8%
38/298 • Number of events 40 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
17.7%
35/198 • Number of events 37 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
11.1%
21/190 • Number of events 22 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
8.4%
25/296 • Number of events 26 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Infections and infestations
Non-COVID infection
|
9.7%
29/298 • Number of events 35 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
7.1%
14/198 • Number of events 16 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
11.1%
21/190 • Number of events 23 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
4.4%
13/296 • Number of events 15 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
|
Gastrointestinal disorders
Gastrointestinal issues
|
6.7%
20/298 • Number of events 23 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
6.1%
12/198 • Number of events 12 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
9.5%
18/190 • Number of events 21 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
|
5.4%
16/296 • Number of events 18 • 1 year from randomization
Participants were queried about adverse events during treatment visits and in all monthly surveys. Participants who did not have any treatment visits are excluded from the adverse events tabulations. Thus denominators differ from the overall study population.
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Additional Information
Eric Meier, Study Biostatistician
University of Washington
Phone: 206-450-0020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place