Trial Outcomes & Findings for Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients (NCT NCT02647658)
NCT ID: NCT02647658
Last Updated: 2020-02-10
Results Overview
Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2300 participants
Primary outcome timeframe
6 months from baseline
Results posted on
2020-02-10
Participant Flow
Unit of analysis: Primary Care Clinics
Participant milestones
| Measure |
GBC+PIPT
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Overall Study
STARTED
|
1207 39
|
1093 37
|
|
Overall Study
6 Month Assessment
|
658 38
|
635 35
|
|
Overall Study
COMPLETED
|
1192 39
|
1069 37
|
|
Overall Study
NOT COMPLETED
|
15 0
|
24 0
|
Reasons for withdrawal
| Measure |
GBC+PIPT
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Overall Study
Consent refusal
|
15
|
24
|
Baseline Characteristics
All of those patients who completed the survey.
Baseline characteristics by cohort
| Measure |
GBC+PIPT
n=1207 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1093 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
Total
n=2300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 16.2 • n=1207 Participants
|
50.6 years
STANDARD_DEVIATION 17.1 • n=1093 Participants
|
49.9 years
STANDARD_DEVIATION 16.6 • n=2300 Participants
|
|
Sex: Female, Male
Female
|
721 Participants
n=1207 Participants
|
635 Participants
n=1093 Participants
|
1356 Participants
n=2300 Participants
|
|
Sex: Female, Male
Male
|
486 Participants
n=1207 Participants
|
458 Participants
n=1093 Participants
|
944 Participants
n=2300 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
75 Participants
n=1207 Participants
|
72 Participants
n=1093 Participants
|
147 Participants
n=2300 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1087 Participants
n=1207 Participants
|
995 Participants
n=1093 Participants
|
2082 Participants
n=2300 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=1207 Participants
|
26 Participants
n=1093 Participants
|
71 Participants
n=2300 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
949 Participants
n=1207 Participants
|
769 Participants
n=1093 Participants
|
1718 Participants
n=2300 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
181 Participants
n=1207 Participants
|
224 Participants
n=1093 Participants
|
405 Participants
n=2300 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
25 Participants
n=1207 Participants
|
57 Participants
n=1093 Participants
|
82 Participants
n=2300 Participants
|
|
Race/Ethnicity, Customized
Race · Missing/Unknown
|
52 Participants
n=1207 Participants
|
43 Participants
n=1093 Participants
|
95 Participants
n=2300 Participants
|
|
Oswestry Disability Index
|
48.0 score on scale
STANDARD_DEVIATION 17.4 • n=1161 Participants • All of those patients who completed the survey.
|
48.3 score on scale
STANDARD_DEVIATION 17.5 • n=1063 Participants • All of those patients who completed the survey.
|
48.1 score on scale
STANDARD_DEVIATION 17.4 • n=2224 Participants • All of those patients who completed the survey.
|
|
STarT Back Total
|
7.2 score on a scale
STANDARD_DEVIATION 1.1 • n=1207 Participants
|
7.2 score on a scale
STANDARD_DEVIATION 1.1 • n=1093 Participants
|
7.2 score on a scale
STANDARD_DEVIATION 1.1 • n=2300 Participants
|
|
STarT Back Subscore
|
4.4 score on a scale
STANDARD_DEVIATION 0.5 • n=1207 Participants
|
4.3 score on a scale
STANDARD_DEVIATION 0.5 • n=1093 Participants
|
4.4 score on a scale
STANDARD_DEVIATION 0.5 • n=2300 Participants
|
PRIMARY outcome
Timeframe: 6 months from baselinePopulation: Among participants with assessment data at 6 months
Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.
Outcome measures
| Measure |
GBC+PIPT
n=658 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=635 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)
|
312 Participants
|
318 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants with assessment data at 6 months.
Measured using the 10-item Oswestry Disability Index (version 2.1a). Also known as the Oswestry Low Back Pain Disability Questionnaire. A measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability.
Outcome measures
| Measure |
GBC+PIPT
n=658 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=635 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Functional Disability
|
27.3 score on a scale
Interval 25.4 to 29.3
|
29.5 score on a scale
Interval 27.5 to 31.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All screened excluding those not consented for EMR follow up at 12 months at 1 site.
Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.
Outcome measures
| Measure |
GBC+PIPT
n=1192 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1069 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients Referred to Physical Therapy
|
106 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All screened excluding patients that did not consent to EMR data at 12 months at 1 site.
Medication prescription for opioids measured using electronic health records over 12 months.
Outcome measures
| Measure |
GBC+PIPT
n=1192 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1069 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients Prescribed Opioids
|
89 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records
Outcome measures
| Measure |
GBC+PIPT
n=1192 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1069 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients With Orders for Diagnostic Imaging Tests
|
74 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records
Outcome measures
| Measure |
GBC+PIPT
n=1192 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1069 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients Referred to Other Rehabilitation or Pain Management Specialist
|
45 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records
Outcome measures
| Measure |
GBC+PIPT
n=1192 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1069 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients Referred to Surgery Specialist
|
38 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records
Outcome measures
| Measure |
GBC+PIPT
n=1192 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1069 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients Undergoing Interventional Pain Procedures
|
32 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
Documentation that patient underwent back surgery in electronic health records
Outcome measures
| Measure |
GBC+PIPT
n=1192 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1069 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients Who Had Back Surgery
|
29 Participants
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 21 days after initial visit for acute low back painMedication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization.
Outcome measures
| Measure |
GBC+PIPT
n=1207 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1093 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients Prescribed Opioids
|
300 Participants
|
270 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 21 days after initial visit for acute low back painPatient referred to physical therapy or psychologically informed physical therapy measured using electronic health records at the index baseline visit. This is a measure of intervention fidelity post-randomization of the clinics.
Outcome measures
| Measure |
GBC+PIPT
n=1207 Participants
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
|
Guideline Based Care
n=1093 Participants
Guideline Based Care (GBC)
Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
|
|---|---|---|
|
Number of Patients Referred to Physical Therapy
|
658 Participants
|
335 Participants
|
Adverse Events
GBC+PIPT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Guideline Based Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place