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

University of Minnesota (UMN)

Status: Completed

Conditions: Pain, Chronic; Sciatica; Back Related Leg Pain; Intervertebral Disc Displacement; Low Back Pain

Treatments: Drug: Medical Care; Behavioral: Supported Biopsychosocial Self-Management (SBSM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05022121

CSH-2021-30117

R34AT011209

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Supported Biopsychosocial Self-Management (SBSM)

Experimental group

Description:

Supported Biopsychosocial Self-Management (SBSM)

Treatment:

Behavioral: Supported Biopsychosocial Self-Management (SBSM)

Medical Care

Active Comparator group

Description:

Medical Care

Treatment:

Drug: Medical Care