Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

Not Applicable

Completed

• Conditions: Intervertebral Disc Displacement; Back Related Leg Pain; Low Back Pain; Sciatica; Pain, Chronic
• Interventions: Drug: Medical Care; Behavioral: Supported Biopsychosocial Self-Management (SBSM)

• Registration Number: NCT05022121
• Lead Sponsor: University of Minnesota

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Study Start: 2022-01-26
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-20
• Status Verified: 2024-02
• Results First Submitted: 2024-02-15
• Results First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Results First Posted: 2024-03-15
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical Care	Medical Care	Medical Care
Supported Biopsychosocial Self-Management (SBSM)	Supported Biopsychosocial Self-Management (SBSM)	Supported Biopsychosocial Self-Management (SBSM)

Primary Outcome Measures

Name	Time	Method
Percentage of Screened Participants Who Are Female	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	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	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 Enrolled Participants Who Are From Racial or Ethnic Minority Populations	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 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 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	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	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	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	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	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 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 is reported.
Number of Particpants Screened Per Month	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	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	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	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	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.

Trial Locations

Locations (2)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States