Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

• Status: Not yet recruiting
• Trial end date: 2022-10-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota
• Collaborators: Duke University; National Center for Complementary and Integrative Health (NCCIH); University of Pittsburgh

Criteria

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).