N/A
Completed N=42
Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
Low Back Pain · Sciatica · Back Related Leg Pain · Pain, Chronic
Source: ClinicalTrials.gov NCT05022121 ↗
Enrolled (actual)
42
Serious AEs
4.8%
Results posted
Mar 2024
Primary outcomePrimary: Number of Particpants Screened Per Month — 103 participants per month
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).
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 | — |
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).
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. Informational only — not medical advice.