Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

Study Overview
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Brief Summary
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Guidelines advocate several complementary modalities as alternatives to drugs and other invasive treatments for chronic low back pain (LBP) conditions. However, there is little high-quality research investigating treatments for back-related leg pain, one of the more severe and disabling presentations of LBP. The investigators are conducting a pilot study to assess the feasibility of a future phase II multi-site randomized clinical trial (RCT). The future trial will assess the comparative effectiveness of a novel supported biopsychosocial self-management (SBSM) intervention versus Medical Care (MC).

Official Title
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Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

Conditions
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Low Back Pain, Sciatica, Back Related Leg Pain, Pain, Chronic, Intervertebral Disc Displacement

Intervention / Treatment
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* Behavioral: Supported Biopsychosocial Self-Management (SBSM)
* Drug: Medical Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Back-related leg pain (BRLP) consistent with the Quebec Task Force (QTF) classifications 2-4 (radiating pain into proximal or distal extremity with or without neurological signs). 18 years of age or older. Back-related leg pain severity of 3 or higher at all screening assessments (0 to 10 scale) Episode duration of 12 weeks or more Ability to read English fluently Exclusion Criteria: Spinal stenosis (QTF 7) Specific, non-mechanical causes of BRLP (QTF 11; e.g. infection, tumor) Contraindications to study interventions (e.g. spinal fracture (QTF 5)) Inflammatory conditions of the lumbar spine (QTF 11) Lumbar fusion Progressive neurological deficits Cauda equina syndrome Pregnancy, nursing Ongoing care from another healthcare provider for BRLP Severe unmanaged comorbid conditions (e.g. substance abuse, major depressive disorder, stage 3 hypertension).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supported Biopsychosocial Self-Management (SBSM)<br>Supported Biopsychosocial Self-Management (SBSM) | Behavioral: Supported Biopsychosocial Self-Management (SBSM)<br>* Participants receive training and instruction in skills to engage in healthy physical, psychological, and social self-management behaviors. This will be accomplished through 6-12 sessions with a trained chiropractor or physical therapist. Patients will receive training and instruction in exercises targeting posture, strength, stabilization, and mobility based on their individual needs. They will learn psychological strategies including problem solving and cognitive restructuring to address unhelpful thoughts and emotions. Social strategies include pleasant activity planning with a social focus, and communication techniques for navigating relationships to garner support for self-sufficiency. Other elements include providing key evidence based information about BRLP and spinal manipulation therapies (SMT). SMT will include manipulation, mobilization and soft-tissue treatment. Other intervention elements include enablement, persuasion, and resources and materials to support the patient.<br>|
| Active Comparator: Medical Care<br>Medical Care | Drug: Medical Care<br>* Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of particpants screened per month | As a measure of recruitment feasibility, the average number of participants screened per month will be reported as an integer value. | Through study enrollment, an average of 6 months | 
| Percentage of screened participants who are female | As a measure of recruitment feasibility, the number of female participants in the study will be reported as a percent value of all participants. | Through study enrollment, an average of 6 months | 
| Percentage of screened participants who are minorities | As a measure of recruitment feasibility, the number of minority participants in the study will be reported as a percent value of all participants. | Through study enrollment, an average of 6 months | 
| Number of participants enrolled per month | As a measure of enrollment feasibility, the average number of participants recruited per month will be reported as an integer value. | Through study enrollment, an average of 6 months | 
| Percentage of enrolled participants who are female | As a measure of enrollment feasibility, the number of female participants enrolled in the study will be reported as a percent value of all participants. | Through study enrollment, an average of 6 months | 
| Percentage of enrolled participants who are minorities | As a measure of enrollment feasibility, the number of minority participants enrolled in the study will be reported as a percent value of all participants. | Through study enrollment, an average of 6 months | 
| Percentage of enrollees not receiving any treatment | As a measure of intervention acceptability and credibility associated with feasibility, the number of enrollees not receiving any treatment will be reported as a percent value of all enrollees. | Through study treatment, an average of 3 months | 
| Percentage of enrollees receiving prohibited treatments | As a measure of intervention acceptability and credibility associated with feasibility, the number of enrollees receiving prohibited treatments, (contamination), during the 12-week intervention phase of the study will be reported as a percent value of all enrollees. | Through study treatment, an average of 3 months | 
| Percentage of enrollees satisfied with treatment | As a measure of intervention acceptability and credibility associated with feasibility, treatment satisfaction will be reported by participants via a 7-point Likert satisfaction scale, ranging from 1, completely satisfied, to 7, completely dissatisfied, where lower numbers indicate greater satisfaction. The percentage of enrollees satisfied with treatment will be reported as a percent value representing those who choose somewhat satisfied or better on the scale. | Through study treatment, an average of 3 months | 
| Percentage of enrollees attending required sessions | As a measure of participant treatment adherence associated with feasibility, the number of enrollees attending required study sessions will be reported as a percent value. | Through study treatment, an average of 3 months | 
| Percentage of enrollees in supported biopsychosocial self-management group reporting participation in home practice | As a measure of participant treatment adherence associated with feasibility, the number of enrollees who are part of the supported biopsychosocial self-management arm of the study who self-report participation in home treatment practice will be reported as a percent value. | Through study treatment, an average of 3 months | 
| Percentage of enrollees in medical care group reporting taking medications as prescribed | As a measure of participant treatment adherence associated with feasibility, the number of enrollees who are part of the medical care arm self-reporting taking medications as prescribed will be reported as a percent value. | Through study treatment, an average of 3 months | 
| Percentage of provider visits where all required intervention activities were delivered | As a measure of provider fidelity, the percentage of provider vists where 100% of required intervention activities were delivered will be reported as a percent value. | Through study treatment, an average of 3 months | 
| Percentage of enrollees completing the month 3 assessment | As a measure of data collection feasibility, the number of enrollees completing the month 3 assessment will be reported as a percent value. | Month 3 assessment | 
| Percentage of enrollees completing the month 6 assessment | As a measure of data collection feasibility, the number of enrollees completing the month 6 assessment will be reported as a percent value. | Month 6 assessment | 
| Percentage of weekly pain severity and frequency assessments completed | As a measure of data collection feasibility, the number of weekly pain severity and frequency assessments completed by participants will be reported as a percent value. | Through completion of all weekly assessments, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants screened per month by recruitment method | As an element of recruitment protocol refinement, the mean number of participants screened per month by recruitment method will be reported as percent values. | Through study enrollment, an average of 6 months | 
| Percentage of participants screened who are female by recruitment method | As an element of recruitment protocol refinement, the number of female participants screened by recruitment method will be reported as a percent value. | Through study enrollment, an average of 6 months | 
| Percentage of participants screened who are minorities by recruitment method | As an element of recruitment protocol refinement, the number of minority participants screened by recruitment method will be reported as a percent value. | Through study enrollment, an average of 6 months | 
| Percentage of participants excluded by eligibility criterion | As an element of enrollment protocol refinement, the number of participants excluded from the study by eligibility criterion will be reported as percent values. | Through study enrollment, an average of 6 months | 
| Percentage of participants declining participation | As an element of enrollment protocol refinement, the number of participants who decline participation will be reported as a percent value. The participants will also have the opportunity to communicate their reasons for declining participation from qualitatively. | Through study enrollment, an average of 6 months | 
| Average time to enrollment from initial screening | As an element of enrollment protcol refinement, the mean time to participant enrollmet from initial screening will be reported as an integer. | Through study enrollment, an average of 6 months | 
| Percentage of enrollees withdrawing from treatment | As an element of intervention protocol refinement, the number of enrollees who withdraw from treatment will be reported as a percent value. Participants will also be provided with the opportunity to share their reasons for withdrawal qualitatively. | Through study treatment, an average of 3 months | 
| Percentage of required intervention activities not performed by provider | As an element of intervention protocol refinement, the number of required intervention activities not performed by the provider will be reported as a percent value. | Through study treatment, an average of 3 months |