Trial Outcomes & Findings for Management Strategies for Patients With Low Back Pain and Sciatica (NCT NCT02391350)
NCT ID: NCT02391350
Last Updated: 2021-01-22
Results Overview
Patient-reported disability due to low back pain. Scores range from 0-100 with higher scores indicating greater disability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
220 participants
Primary outcome timeframe
Baseline, 4 weeks, 6 months, 1 year
Results posted on
2021-01-22
Participant Flow
Participants were recruited from February 2015 through October, 2018. Recruitment was done in 2 health systems (University of Utah and Intermountain Healthcare) in Salt Lake City, Utah. Potential participants were identified using electronic health records and were sent a letter about the study after completing a primary care visit. A research team made follow-up telephone calls to identify those interested in meeting with a research assistant to determine eligibility and provide consent.
Participant milestones
| Measure |
Usual Care
Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
|
Early Intervention
Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
110
|
|
Overall Study
4-week Follow-up
|
106
|
105
|
|
Overall Study
6-month Follow-up
|
100
|
96
|
|
Overall Study
COMPLETED
|
98
|
93
|
|
Overall Study
NOT COMPLETED
|
12
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was missing for one participant in the usual care group.
Baseline characteristics by cohort
| Measure |
Usual Care
n=110 Participants
Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
|
Early Intervention
n=110 Participants
Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 11.2 • n=109 Participants • Age was missing for one participant in the usual care group.
|
40.0 years
STANDARD_DEVIATION 11.2 • n=110 Participants • Age was missing for one participant in the usual care group.
|
39.0 years
STANDARD_DEVIATION 11.2 • n=219 Participants • Age was missing for one participant in the usual care group.
|
|
Sex: Female, Male
Female
|
59 Participants
n=110 Participants • Gender missing for one participant in Early Intervention
|
48 Participants
n=109 Participants • Gender missing for one participant in Early Intervention
|
107 Participants
n=219 Participants • Gender missing for one participant in Early Intervention
|
|
Sex: Female, Male
Male
|
51 Participants
n=110 Participants • Gender missing for one participant in Early Intervention
|
61 Participants
n=109 Participants • Gender missing for one participant in Early Intervention
|
112 Participants
n=219 Participants • Gender missing for one participant in Early Intervention
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=110 Participants
|
14 Participants
n=110 Participants
|
30 Participants
n=220 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=110 Participants
|
81 Participants
n=110 Participants
|
165 Participants
n=220 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=110 Participants
|
15 Participants
n=110 Participants
|
25 Participants
n=220 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=110 Participants
|
5 Participants
n=110 Participants
|
7 Participants
n=220 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=110 Participants
|
2 Participants
n=110 Participants
|
7 Participants
n=220 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=110 Participants
|
1 Participants
n=110 Participants
|
2 Participants
n=220 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=110 Participants
|
1 Participants
n=110 Participants
|
4 Participants
n=220 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=110 Participants
|
92 Participants
n=110 Participants
|
181 Participants
n=220 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=110 Participants
|
7 Participants
n=110 Participants
|
14 Participants
n=220 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=110 Participants
|
2 Participants
n=110 Participants
|
5 Participants
n=220 Participants
|
|
Duration of Symptoms
|
35.9 days
STANDARD_DEVIATION 26.8 • n=109 Participants • Duration of symptoms data was missing for one participant in Usual Care at Baseline
|
35.8 days
STANDARD_DEVIATION 25.6 • n=110 Participants • Duration of symptoms data was missing for one participant in Usual Care at Baseline
|
35.8 days
STANDARD_DEVIATION 26.1 • n=219 Participants • Duration of symptoms data was missing for one participant in Usual Care at Baseline
|
|
StartBack Risk Category
High Risk
|
28 Participants
n=110 Participants
|
26 Participants
n=110 Participants
|
54 Participants
n=220 Participants
|
|
StartBack Risk Category
Medium Risk
|
63 Participants
n=110 Participants
|
68 Participants
n=110 Participants
|
131 Participants
n=220 Participants
|
|
StartBack Risk Category
Low Risk
|
19 Participants
n=110 Participants
|
16 Participants
n=110 Participants
|
35 Participants
n=220 Participants
|
|
Oswestry Disability Index
|
35.8 units on a scale
STANDARD_DEVIATION 15.8 • n=110 Participants
|
38.9 units on a scale
STANDARD_DEVIATION 13.8 • n=110 Participants
|
37.3 units on a scale
STANDARD_DEVIATION 14.9 • n=220 Participants
|
|
Back Pain Intensity Rating
|
4.8 units on a 0-10 scale
STANDARD_DEVIATION 1.9 • n=110 Participants
|
5.1 units on a 0-10 scale
STANDARD_DEVIATION 1.8 • n=110 Participants
|
5.0 units on a 0-10 scale
STANDARD_DEVIATION 1.9 • n=220 Participants
|
|
Leg Pain Intensity Rating
|
3.8 units on a 0-10 scale
STANDARD_DEVIATION 2.2 • n=110 Participants • Leg pain intensity rating was missing at baseline for one participant in the Early Intervention group.
|
4.3 units on a 0-10 scale
STANDARD_DEVIATION 2.2 • n=109 Participants • Leg pain intensity rating was missing at baseline for one participant in the Early Intervention group.
|
4.1 units on a 0-10 scale
STANDARD_DEVIATION 2.2 • n=219 Participants • Leg pain intensity rating was missing at baseline for one participant in the Early Intervention group.
|
|
Euroqol 5 Dimensions (EQ-5D)
|
0.64 units on a scale
STANDARD_DEVIATION 0.20 • n=107 Participants • Baseline values were missing for 3 participants in Usual Care and 6 participants in Early Physical Therapy group.
|
0.64 units on a scale
STANDARD_DEVIATION 0.20 • n=104 Participants • Baseline values were missing for 3 participants in Usual Care and 6 participants in Early Physical Therapy group.
|
0.64 units on a scale
STANDARD_DEVIATION 0.20 • n=211 Participants • Baseline values were missing for 3 participants in Usual Care and 6 participants in Early Physical Therapy group.
|
|
Pain Catastrophizing Scale
|
19.0 units on a scale
STANDARD_DEVIATION 11.9 • n=108 Participants • Pain Catastrophizing Scale was missing at baseline for 2 participants in Usual Care and 3 participants in Early Physical Therapy group.
|
20.9 units on a scale
STANDARD_DEVIATION 12.6 • n=107 Participants • Pain Catastrophizing Scale was missing at baseline for 2 participants in Usual Care and 3 participants in Early Physical Therapy group.
|
19.9 units on a scale
STANDARD_DEVIATION 12.3 • n=215 Participants • Pain Catastrophizing Scale was missing at baseline for 2 participants in Usual Care and 3 participants in Early Physical Therapy group.
|
|
Fear-Avoidance Beliefs - Physical Activity
|
14.0 units on a scale
STANDARD_DEVIATION 5.9 • n=109 Participants • Fear avoidance beliefs about physical activity data was missing for one participant in usual care group
|
15.2 units on a scale
STANDARD_DEVIATION 5.7 • n=110 Participants • Fear avoidance beliefs about physical activity data was missing for one participant in usual care group
|
14.6 units on a scale
STANDARD_DEVIATION 5.8 • n=219 Participants • Fear avoidance beliefs about physical activity data was missing for one participant in usual care group
|
|
Fear-Avoidance Beliefs - Work
|
13.9 units on a scale
STANDARD_DEVIATION 11.8 • n=109 Participants • The Fear Avoidance Beliefs about Work questionnaire was missing for 4 participants in the Early Intervention group and 1 participant in the Usual Care group.
|
15.4 units on a scale
STANDARD_DEVIATION 12.3 • n=106 Participants • The Fear Avoidance Beliefs about Work questionnaire was missing for 4 participants in the Early Intervention group and 1 participant in the Usual Care group.
|
14.6 units on a scale
STANDARD_DEVIATION 12.0 • n=215 Participants • The Fear Avoidance Beliefs about Work questionnaire was missing for 4 participants in the Early Intervention group and 1 participant in the Usual Care group.
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 6 months, 1 yearPopulation: Missing data across follow-up is outlined by group
Patient-reported disability due to low back pain. Scores range from 0-100 with higher scores indicating greater disability.
Outcome measures
| Measure |
Usual Care
n=106 Participants
Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
|
Early Intervention
n=105 Participants
Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
|
|---|---|---|
|
Change From Baseline in Oswestry Disability Index
4 Weeks
|
-8.8 units on a scale
Interval -11.5 to -6.0
|
-17.0 units on a scale
Interval -19.7 to -14.2
|
|
Change From Baseline in Oswestry Disability Index
6 months
|
-17.0 units on a scale
Interval -19.9 to -14.2
|
-22.4 units on a scale
Interval -25.3 to -19.6
|
|
Change From Baseline in Oswestry Disability Index
1 year
|
-17.7 units on a scale
Interval -20.6 to -14.8
|
-22.5 units on a scale
Interval -25.4 to -19.5
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 6 months, 1 yearPopulation: Missing data reflected across follow-up points
Separate rating for low back pain and leg pain intensity on a 0-10 scale. Higher numbers indicate greater pain intensity.
Outcome measures
| Measure |
Usual Care
n=106 Participants
Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
|
Early Intervention
n=105 Participants
Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
|
|---|---|---|
|
Change From Baseline in Numeric Pain Ratings
Back pain intensity 4 weeks
|
-1.0 units on a scale
Interval -1.4 to -0.6
|
-2.4 units on a scale
Interval -2.8 to -2.1
|
|
Change From Baseline in Numeric Pain Ratings
Back pain intensity 6 months
|
-1.5 units on a scale
Interval -1.9 to -1.1
|
-2.3 units on a scale
Interval -2.7 to -1.9
|
|
Change From Baseline in Numeric Pain Ratings
Back pain intensity 1 year
|
-1.6 units on a scale
Interval -2.0 to -1.2
|
-2.6 units on a scale
Interval -3.0 to -2.2
|
|
Change From Baseline in Numeric Pain Ratings
Leg pain intensity 4 weeks
|
-1.0 units on a scale
Interval -1.4 to -0.6
|
-1.8 units on a scale
Interval -2.3 to -1.4
|
|
Change From Baseline in Numeric Pain Ratings
Leg pain intensity 6 months
|
-1.9 units on a scale
Interval -2.3 to -1.5
|
-1.8 units on a scale
Interval -2.2 to -1.3
|
|
Change From Baseline in Numeric Pain Ratings
Leg pain intensity 1 year
|
-1.8 units on a scale
Interval -2.2 to -1.3
|
-2.2 units on a scale
Interval -2.7 to -1.8
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 6 months, 1 yearPopulation: Missing data noted across all follow-up points
Self-report measure of Quality of Life. Scores range from 0 - 1.0, with higher scores indicating greater quality of life.
Outcome measures
| Measure |
Usual Care
n=106 Participants
Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
|
Early Intervention
n=105 Participants
Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
|
|---|---|---|
|
Change From Baseline in EQ-5D
EQ-5D 4 weeks
|
0.05 score on a scale
Interval 0.02 to 0.08
|
0.12 score on a scale
Interval 0.08 to 0.15
|
|
Change From Baseline in EQ-5D
EQ-5D 6 months
|
0.14 score on a scale
Interval 0.1 to 0.17
|
0.15 score on a scale
Interval 0.12 to 0.19
|
|
Change From Baseline in EQ-5D
EQ-5D 1 year
|
0.13 score on a scale
Interval 0.1 to 0.17
|
0.17 score on a scale
Interval 0.14 to 0.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4 weeks, 6 months, 1 yearPopulation: Missing data noted across follow-up time points
Fear Avoidance Beliefs about physical activity and work on separate scales. The Fear avoidance about physical activity scale assesses participants' concern that physical activity will harm their back. Scores range from 0-24 with higher scores indicating greater fear of physical activity. The Fear avoidance about work scale assesses participants' concern that work-related activity will harm their back. Scores range from 0-42 with higher scores indicating greater fear of physical activity.
Outcome measures
| Measure |
Usual Care
n=106 Participants
Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
|
Early Intervention
n=105 Participants
Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
|
|---|---|---|
|
Change From Baseline in Fear-Avoidance Beliefs
Fear-Avoidance Beliefs - physical activity, 4 weeks
|
-3.2 units on a scale
Interval -4.4 to -2.0
|
-4.9 units on a scale
Interval -6.1 to -3.7
|
|
Change From Baseline in Fear-Avoidance Beliefs
Fear-Avoidance Beliefs - physical activity, 6 months
|
-4.9 units on a scale
Interval -6.1 to -3.6
|
-5.6 units on a scale
Interval -6.9 to -4.3
|
|
Change From Baseline in Fear-Avoidance Beliefs
Fear-Avoidance Beliefs - physical activity, 1 year
|
-3.7 units on a scale
Interval -5.0 to -2.5
|
-7.3 units on a scale
Interval -8.6 to -6.0
|
|
Change From Baseline in Fear-Avoidance Beliefs
Fear-Avoidance Beliefs - work, 4 weeks
|
-1.4 units on a scale
Interval -3.1 to 0.2
|
-3.0 units on a scale
Interval -4.7 to -1.3
|
|
Change From Baseline in Fear-Avoidance Beliefs
Fear-Avoidance Beliefs - work, 6 months
|
-3.2 units on a scale
Interval -4.9 to -1.4
|
-5.0 units on a scale
Interval -6.8 to -3.3
|
|
Change From Baseline in Fear-Avoidance Beliefs
Fear-Avoidance Beliefs - work, 1 year
|
-2.6 units on a scale
Interval -4.3 to -0.9
|
-6.2 units on a scale
Interval -8.0 to -4.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4 weeks, 6 months, 1 yearPopulation: Missing data reflected across time points
Self-reported measure assessing the extent to which a participant experiences catastrophizing cognitions about back pain (e.g., feelings of helplessness, hypervigilance etc.). Scores range from 13-52 with higher numbers indicating greater catastrophizing cognitions.
Outcome measures
| Measure |
Usual Care
n=106 Participants
Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
|
Early Intervention
n=105 Participants
Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
|
|---|---|---|
|
Change From Baseline in Pain Catastrophizing Scale
Pain catastrophizing - 4 weeks
|
-3.7 units on a scale
Interval -5.5 to -1.9
|
-5.6 units on a scale
Interval -7.5 to -3.7
|
|
Change From Baseline in Pain Catastrophizing Scale
Pain catastrophizing - 6 months
|
-6.7 units on a scale
Interval -8.7 to -4.8
|
-8.0 units on a scale
Interval -9.9 to -6.1
|
|
Change From Baseline in Pain Catastrophizing Scale
Pain catastrophizing - 1 year
|
-7.8 units on a scale
Interval -9.7 to -5.9
|
-9.0 units on a scale
Interval -11.0 to -7.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: monthly throughout 12 month follow-up periodPopulation: Health care utilization over 1 year follow-up period. Participants are included in the analyses if at least one monthly utilization report was provided over the 12 month follow-up period.
collected via online diaries
Outcome measures
| Measure |
Usual Care
n=109 Participants
Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
|
Early Intervention
n=108 Participants
Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
|
|---|---|---|
|
Number of Participants Utilizing Healthcare
Lumbar spine surgery
|
7 Participants
|
9 Participants
|
|
Number of Participants Utilizing Healthcare
Lumbar injections
|
14 Participants
|
15 Participants
|
|
Number of Participants Utilizing Healthcare
Advanced Imaging
|
31 Participants
|
24 Participants
|
|
Number of Participants Utilizing Healthcare
Emergency Department Visit
|
11 Participants
|
10 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Early Intervention
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Usual Care
n=110 participants at risk
Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
|
Early Intervention
n=110 participants at risk
Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.
Education and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
Physical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
back surgery
|
6.4%
7/110 • Number of events 7 • 1 year
|
8.2%
9/110 • Number of events 9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
injections
|
12.7%
14/110 • Number of events 20 • 1 year
|
13.6%
15/110 • Number of events 25 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place