Skip to main content
OpenTrials
Completed

NCT Number: NCT05022121

Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Back Related Leg Pain Bone Diseases Chronic Pain Hernia Intervertebral Disc Displacement Mononeuropathies Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Chronic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Sciatica Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Supported Biopsychosocial Self-Management (SBSM)

Behavioral

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

Drug

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

    Time frame: 6 month period of active study screening

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

  2. Percentage of Screened Participants Who Are Female

    Time frame: 6 month period of active study screening

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

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

    Time frame: 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.

  4. Number of Participants Enrolled Per Month

    Time frame: 6 month period of active study screening

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

  5. Percentage of Enrolled Participants Who Are Female

    Time frame: 6 month period of active study enrollment

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

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

    Time frame: 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.

  7. Percentage of Enrollees Not Receiving Any Treatment

    Time frame: 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.

  8. Percentage of Enrollees Receiving Prohibited Treatments

    Time frame: 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.

  9. Percentage of Enrollees Satisfied With Treatment

    Time frame: 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.

  10. Percentage of Enrollees Attending Required Sessions

    Time frame: 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.

  11. Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice

    Time frame: 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.

  12. Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed

    Time frame: 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.

  13. Percentage of Provider Visits Where All Required Intervention Activities Were Delivered

    Time frame: 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.

  14. Percentage of Enrollees Completing the Month 3 Assessment

    Time frame: Month 3 assessment

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

  15. Percentage of Enrollees Completing the Month 6 Assessment

    Time frame: Month 6 assessment

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

  16. Percentage of Weekly Pain Severity and Frequency Assessments Completed

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Duke University
  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Pittsburgh

Registry information

Acronym: SUPPORT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2021
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.