SUPPORT: Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Supported Biopsychosocial Self-Management (SBSM) Supported Biopsychosocial Self-Management (SBSM) |
Behavioral: Supported Biopsychosocial Self-Management (SBSM)
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.
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| Active Comparator: Medical Care Medical Care |
Drug: Medical Care
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.
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Outcome Measures
Primary Outcome Measures
- Number of particpants screened per month [Through study enrollment, an average of 6 months]
As a measure of recruitment feasibility, the average number of participants screened per month will be reported as an integer value.
- Percentage of screened participants who are female [Through study enrollment, an average of 6 months]
As a measure of recruitment feasibility, the number of female participants in the study will be reported as a percent value of all participants.
- Percentage of screened participants who are minorities [Through study enrollment, an average of 6 months]
As a measure of recruitment feasibility, the number of minority participants in the study will be reported as a percent value of all participants.
- Number of participants enrolled per month [Through study enrollment, an average of 6 months]
As a measure of enrollment feasibility, the average number of participants recruited per month will be reported as an integer value.
- Percentage of enrolled participants who are female [Through study enrollment, an average of 6 months]
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.
- Percentage of enrolled participants who are minorities [Through study enrollment, an average of 6 months]
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.
- Percentage of enrollees not receiving any treatment [Through study treatment, an average of 3 months]
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.
- Percentage of enrollees receiving prohibited treatments [Through study treatment, an average of 3 months]
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.
- Percentage of enrollees satisfied with treatment [Through study treatment, an average of 3 months]
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.
- Percentage of enrollees attending required sessions [Through study treatment, an average of 3 months]
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.
- Percentage of enrollees in supported biopsychosocial self-management group reporting participation in home practice [Through study treatment, an average of 3 months]
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.
- Percentage of enrollees in medical care group reporting taking medications as prescribed [Through study treatment, an average of 3 months]
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.
- Percentage of provider visits where all required intervention activities were delivered [Through study treatment, an average of 3 months]
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.
- Percentage of enrollees completing the month 3 assessment [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.
- Percentage of enrollees completing the month 6 assessment [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.
- Percentage of weekly pain severity and frequency assessments completed [Through completion of all weekly assessments, an average of 6 months]
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.
Secondary Outcome Measures
- Percentage of participants screened per month by recruitment method [Through study enrollment, an average of 6 months]
As an element of recruitment protocol refinement, the mean number of participants screened per month by recruitment method will be reported as percent values.
- Percentage of participants screened who are female by recruitment method [Through study enrollment, an average of 6 months]
As an element of recruitment protocol refinement, the number of female participants screened by recruitment method will be reported as a percent value.
- Percentage of participants screened who are minorities by recruitment method [Through study enrollment, an average of 6 months]
As an element of recruitment protocol refinement, the number of minority participants screened by recruitment method will be reported as a percent value.
- Percentage of participants excluded by eligibility criterion [Through study enrollment, an average of 6 months]
As an element of enrollment protocol refinement, the number of participants excluded from the study by eligibility criterion will be reported as percent values.
- Percentage of participants declining participation [Through study enrollment, an average of 6 months]
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.
- Average time to enrollment from initial screening [Through study enrollment, an average of 6 months]
As an element of enrollment protcol refinement, the mean time to participant enrollmet from initial screening will be reported as an integer.
- Percentage of enrollees withdrawing from treatment [Through study treatment, an average of 3 months]
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.
- Percentage of required intervention activities not performed by provider [Through study treatment, an average of 3 months]
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.
Other Outcome Measures
- Provider views of intervention [Through study treatment, an average of 3 months]
As an element of protocol refinement, provider views of the intervention pertaining to afforability, practicalitym effectiveness, acceptability, and equity will be assessed via open-ended, qualitative questions issued via questionnaire in addition to semi-structured interviews.
- Enrollee views of intervention [Through study treatment, an average of 3 months]
As an element of protocol refinement, enrollee views of the intervention pertaining to afforability, practicalitym effectiveness, acceptability, and equity will be assessed via open-ended, qualitative questions issued via questionnaire in addition to semi-structured interviews.
- Provider beliefs regarding back-related leg pain [Through study treatment, an average of 3 months]
As an element of intervention protocol refinement, provider beliefs regarding back-related leg pain will be assed via open-ended, qualitative questions issued via questionnaire and semi-structured interviews.
- Participant views and perspectives on research participation [Through study enrollment, an average of 6 months]
As a measure of recruitment and enrollment feasibility, participant views and perspectives on particiaption in the research will be assessed via open-ended, qualitative questions issued via questionnaire.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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18 years of age or older.
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Back-related leg pain severity of 3 or higher at all screening assessments (0 to 10 scale)
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Episode duration of 12 weeks or more
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Ability to read English fluently
Exclusion Criteria:
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Spinal stenosis (QTF 7)
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Specific, non-mechanical causes of BRLP (QTF 11; e.g. infection, tumor)
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Contraindications to study interventions (e.g. spinal fracture (QTF 5))
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Inflammatory conditions of the lumbar spine (QTF 11)
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Lumbar fusion
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Progressive neurological deficits
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Cauda equina syndrome
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Pregnancy, nursing
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Ongoing care from another healthcare provider for BRLP
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Severe unmanaged comorbid conditions (e.g. substance abuse, major depressive disorder, stage 3 hypertension).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 2 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15260 |
Sponsors and Collaborators
- University of Minnesota
- University of Pittsburgh
- Duke University
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Study Director: Linda Hanson, DC, MS, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSH-2021-30117
- R34AT011209