Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
SUPPORT
2 other identifiers
interventional
42
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable low-back-pain
Started Jan 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedStudy Start
First participant enrolled
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2023
CompletedResults Posted
Study results publicly available
March 15, 2024
CompletedMarch 15, 2024
February 1, 2024
1.1 years
May 18, 2021
February 15, 2024
February 15, 2024
Conditions
Outcome Measures
Primary Outcomes (16)
Number of Particpants Screened Per Month
As a measure of recruitment feasibility, the average number of participants screened per month is reported
6 month period of active study screening
Percentage of Screened Participants Who Are Female
As a measure of recruitment feasibility, the number of female participants in the study is reported
6 month period of active study screening
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.
6 month period of active study screening
Number of Participants Enrolled Per Month
As a measure of enrollment feasibility, the average number of participants recruited per month is reported.
6 month period of active study screening
Percentage of Enrolled Participants Who Are Female
As a measure of enrollment feasibility, the number of female participants enrolled in the study is reported.
6 month period of active study enrollment
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.
6 month period of active enrollment
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.
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 is reported.
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 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.
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 the minimum number of required study sessions (6 for SBSM and 2 for Medical Care) are reported.
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 is reported.
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 is reported.
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 is reported.
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 is reported.
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 is reported.
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 is reported.
Through completion of all weekly assessments, an average of 6 months
Study Arms (2)
Supported Biopsychosocial Self-Management (SBSM)
EXPERIMENTALSupported Biopsychosocial Self-Management (SBSM)
Medical Care
ACTIVE COMPARATORMedical Care
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- University of Pittsburghcollaborator
- Duke Universitycollaborator
- National Center for Complementary and Integrative Health (NCCIH)collaborator
Study Sites (2)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brent Leininger
- Organization
- University of Minnesota
Study Officials
- STUDY DIRECTOR
Linda Hanson, DC, MS
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2021
First Posted
August 26, 2021
Study Start
January 26, 2022
Primary Completion
February 20, 2023
Study Completion
February 20, 2023
Last Updated
March 15, 2024
Results First Posted
March 15, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share