Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
Overview
- Phase
- Not Applicable
- Intervention
- Supported Biopsychosocial Self-Management (SBSM)
- Conditions
- Low Back Pain
- Sponsor
- University of Minnesota
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Percentage of Screened Participants Who Are Female
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
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).
Arms & Interventions
Supported Biopsychosocial Self-Management (SBSM)
Supported Biopsychosocial Self-Management (SBSM)
Intervention: Supported Biopsychosocial Self-Management (SBSM)
Medical Care
Medical Care
Intervention: Medical Care
Outcomes
Primary Outcomes
Percentage of Screened Participants Who Are Female
Time Frame: 6 month period of active study screening
As a measure of recruitment feasibility, the number of female participants in the study is reported
Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed
Time Frame: 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 is reported.
Percentage of Provider Visits Where All Required Intervention Activities Were Delivered
Time Frame: 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 is reported.
Percentage of Enrollees Attending Required Sessions
Time Frame: Through study treatment, an average of 3 months
As a measure of participant treatment adherence associated with feasibility, the number of enrollees attending the minimum number of required study sessions (6 for SBSM and 2 for Medical Care) are reported.
Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice
Time Frame: 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 is reported.
Percentage of Enrollees Completing the Month 6 Assessment
Time Frame: Month 6 assessment
As a measure of data collection feasibility, the number of enrollees completing the month 6 assessment is reported.
Percentage of Enrollees Not Receiving Any Treatment
Time Frame: 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 is reported.
Percentage of Enrollees Completing the Month 3 Assessment
Time Frame: Month 3 assessment
As a measure of data collection feasibility, the number of enrollees completing the month 3 assessment is reported.
Percentage of Weekly Pain Severity and Frequency Assessments Completed
Time Frame: 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 is reported.
Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations
Time Frame: 6 month period of active enrollment
As a measure of enrollment feasibility, the number of participants enrolled from racial or ethnic minority populations is reported.
Percentage of Enrollees Receiving Prohibited Treatments
Time Frame: 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 is reported.
Number of Particpants Screened Per Month
Time Frame: 6 month period of active study screening
As a measure of recruitment feasibility, the average number of participants screened per month is reported
Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations
Time Frame: 6 month period of active study screening
As a measure of recruitment feasibility, the number of participants from racial or ethnic minority populations is reported.
Number of Participants Enrolled Per Month
Time Frame: 6 month period of active study screening
As a measure of enrollment feasibility, the average number of participants recruited per month is reported.
Percentage of Enrolled Participants Who Are Female
Time Frame: 6 month period of active study enrollment
As a measure of enrollment feasibility, the number of female participants enrolled in the study is reported.
Percentage of Enrollees Satisfied With Treatment
Time Frame: Through study treatment, an average of 3 months
As a measure of intervention acceptability and credibility associated with feasibility, treatment satisfaction was 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 is reported as a percent value representing those who choose "somewhat satisfied" or better on the scale.