Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
CompletedNot applicableNCT05022121
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
- Conditions
- Low Back Pain
- Sciatica
- Back Related Leg Pain
- Pain, Chronic
- Intervertebral Disc Displacement
- Interventions
- Behavioral: Supported Biopsychosocial Self-Management (SBSM)
- Drug: Medical Care
- Sponsor
- University of Minnesota
- Collaborators
- University of Pittsburgh; Duke University; National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2022-01-26
- Primary completion
- 2023-02-20
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05022121