N/A N=42 Randomized Double-blind Other

Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

Low Back Pain · Sciatica · Back Related Leg Pain · Pain, Chronic · Intervertebral Disc Displacement

Bottom Line

View on ClinicalTrials.gov: NCT05022121 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Mar 2024

Primary outcome: Primary: Number of Particpants Screened Per Month — 103 participants per month

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Supported Biopsychosocial Self-Management (SBSM) (Behavioral); Medical Care (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Particpants Screened Per Month	103	—
PRIMARY Percentage of Screened Participants Who Are Female	414	—
PRIMARY Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations	168	—
PRIMARY Number of Participants Enrolled Per Month	7	—
PRIMARY Percentage of Enrolled Participants Who Are Female	25	—
PRIMARY Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations	8	—
PRIMARY Percentage of Enrollees Not Receiving Any Treatment	0; 1	—
PRIMARY Percentage of Enrollees Receiving Prohibited Treatments	1; 1	—
PRIMARY Percentage of Enrollees Satisfied With Treatment	17; 14	—
PRIMARY Percentage of Enrollees Attending Required Sessions	19; 20	—
PRIMARY Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice	19	—
PRIMARY Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed	17	—
PRIMARY Percentage of Provider Visits Where All Required Intervention Activities Were Delivered	111; 79	—
PRIMARY Percentage of Enrollees Completing the Month 3 Assessment	18; 20	—
PRIMARY Percentage of Enrollees Completing the Month 6 Assessment	18; 20	—
PRIMARY Percentage of Weekly Pain Severity and Frequency Assessments Completed	461; 479	—

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).

Eligibility 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05022121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.