Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

Low Back Pain Clinical Trial

— SUPPORT  

Official title:

Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022121
• Other study ID #: CSH-2021-30117
• Secondary ID: R34AT011209
• Status: Completed
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain
• Intervertebral Disc Displacement
• Low Back Pain
• Pain, Chronic
• Sciatica

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	Duke University, National Center for Complementary and Integrative Health (NCCIH), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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