Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

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• Low Back Pain 2,922
• Sciatica 149
• Chronic Pain 3,227
• Intervertebral Disc Displacement 474

Low Back Pain

2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Study arms

• Experimental
  Supported Biopsychosocial Self-Management (SBSM)

  Supported Biopsychosocial Self-Management (SBSM)

  Behavioral: Supported Biopsychosocial Self-Management (SBSM)

• Active comparator
  Medical Care

  Medical Care

  Drug: Medical Care

Interventions

• BehavioralSupported 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.

• DrugMedical 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.

Primary outcomes

1. Number of Particpants Screened Per Month

   As a measure of recruitment feasibility, the average number of participants screened per month is reported

   Time frame: 6 month period of active study screening

2. Percentage of Screened Participants Who Are Female

   As a measure of recruitment feasibility, the number of female participants in the study is reported

   Time frame: 6 month period of active study screening

3. Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations

   As a measure of recruitment feasibility, the number of participants from racial or ethnic minority populations is reported.

   Time frame: 6 month period of active study screening

4. Number of Participants Enrolled Per Month

   As a measure of enrollment feasibility, the average number of participants recruited per month is reported.

   Time frame: 6 month period of active study screening

5. Percentage of Enrolled Participants Who Are Female

   As a measure of enrollment feasibility, the number of female participants enrolled in the study is reported.

   Time frame: 6 month period of active study enrollment

6. Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations

   As a measure of enrollment feasibility, the number of participants enrolled from racial or ethnic minority populations is reported.

   Time frame: 6 month period of active enrollment

7. 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 is reported.

   Time frame: Through study treatment, an average of 3 months

8. 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 is reported.

   Time frame: Through study treatment, an average of 3 months

9. Percentage of Enrollees Satisfied With Treatment

   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.

   Time frame: Through study treatment, an average of 3 months

10. Percentage of Enrollees Attending Required Sessions

    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.

    Time frame: Through study treatment, an average of 3 months

11. 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 is reported.

    Time frame: Through study treatment, an average of 3 months

12. 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 is reported.

    Time frame: Through study treatment, an average of 3 months

13. 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 is reported.

    Time frame: Through study treatment, an average of 3 months

14. Percentage of Enrollees Completing the Month 3 Assessment

    As a measure of data collection feasibility, the number of enrollees completing the month 3 assessment is reported.

    Time frame: Month 3 assessment

15. Percentage of Enrollees Completing the Month 6 Assessment

    As a measure of data collection feasibility, the number of enrollees completing the month 6 assessment is reported.

    Time frame: Month 6 assessment

16. 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 is reported.

    Time frame: Through completion of all weekly assessments, an average of 6 months

Baseline characteristics

Study documents

• Protocol and statistical analysis plan ↗ · Jul 18, 2022
• Informed consent form ↗ · Jul 19, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No