Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (SUPPORT)

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supported Biopsychosocial Self-Management (SBSM)	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.
Active Comparator: Medical Care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants screened per month by recruitment method	As an element of recruitment protocol refinement, the mean number of participants screened per month by recruitment method will be reported as percent values.	Through study enrollment, an average of 6 months
Percentage of participants screened who are female by recruitment method	As an element of recruitment protocol refinement, the number of female participants screened by recruitment method will be reported as a percent value.	Through study enrollment, an average of 6 months
Percentage of participants screened who are minorities by recruitment method	As an element of recruitment protocol refinement, the number of minority participants screened by recruitment method will be reported as a percent value.	Through study enrollment, an average of 6 months
Percentage of participants excluded by eligibility criterion	As an element of enrollment protocol refinement, the number of participants excluded from the study by eligibility criterion will be reported as percent values.	Through study enrollment, an average of 6 months
Percentage of participants declining participation	As an element of enrollment protocol refinement, the number of participants who decline participation will be reported as a percent value. The participants will also have the opportunity to communicate their reasons for declining participation from qualitatively.	Through study enrollment, an average of 6 months
Average time to enrollment from initial screening	As an element of enrollment protcol refinement, the mean time to participant enrollmet from initial screening will be reported as an integer.	Through study enrollment, an average of 6 months
Percentage of enrollees withdrawing from treatment	As an element of intervention protocol refinement, the number of enrollees who withdraw from treatment will be reported as a percent value. Participants will also be provided with the opportunity to share their reasons for withdrawal qualitatively.	Through study treatment, an average of 3 months
Percentage of required intervention activities not performed by provider	As an element of intervention protocol refinement, the number of required intervention activities not performed by the provider will be reported as a percent value.	Through study treatment, an average of 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider views of intervention	As an element of protocol refinement, provider views of the intervention pertaining to afforability, practicalitym effectiveness, acceptability, and equity will be assessed via open-ended, qualitative questions issued via questionnaire in addition to semi-structured interviews.	Through study treatment, an average of 3 months
Enrollee views of intervention	As an element of protocol refinement, enrollee views of the intervention pertaining to afforability, practicalitym effectiveness, acceptability, and equity will be assessed via open-ended, qualitative questions issued via questionnaire in addition to semi-structured interviews.	Through study treatment, an average of 3 months
Provider beliefs regarding back-related leg pain	As an element of intervention protocol refinement, provider beliefs regarding back-related leg pain will be assed via open-ended, qualitative questions issued via questionnaire and semi-structured interviews.	Through study treatment, an average of 3 months
Participant views and perspectives on research participation	As a measure of recruitment and enrollment feasibility, participant views and perspectives on particiaption in the research will be assessed via open-ended, qualitative questions issued via questionnaire.	Through study enrollment, an average of 6 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: University of Pittsburgh; Duke University; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Study Director: Linda Hanson, DC, MS, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Sciatica; Chronic Pain; Intervertebral Disc Displacement
• Other Study ID Numbers: CSH-2021-30117; R34AT011209 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No