Clinical trial NCT05022121: Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
Official title: Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Sciatica
Back Related Leg Pain
Pain, Chronic
Intervertebral Disc Displacement
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Duke University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-08-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

Primary outcomes:
measure: Number of Particpants Screened Per Month
timeFrame: 6 month period of active study screening
measure: Percentage of Screened Participants Who Are Female
timeFrame: 6 month period of active study screening
measure: Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations
timeFrame: 6 month period of active study screening
measure: Number of Participants Enrolled Per Month
timeFrame: 6 month period of active study screening
measure: Percentage of Enrolled Participants Who Are Female
timeFrame: 6 month period of active study enrollment
measure: Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations
timeFrame: 6 month period of active enrollment
measure: Percentage of Enrollees Not Receiving Any Treatment
timeFrame: Through study treatment, an average of 3 months
measure: Percentage of Enrollees Receiving Prohibited Treatments
timeFrame: Through study treatment, an average of 3 months
measure: Percentage of Enrollees Satisfied With Treatment
timeFrame: Through study treatment, an average of 3 months
measure: Percentage of Enrollees Attending Required Sessions
timeFrame: Through study treatment, an average of 3 months
measure: Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice
timeFrame: Through study treatment, an average of 3 months
measure: Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed
timeFrame: Through study treatment, an average of 3 months
measure: Percentage of Provider Visits Where All Required Intervention Activities Were Delivered
timeFrame: Through study treatment, an average of 3 months
measure: Percentage of Enrollees Completing the Month 3 Assessment
timeFrame: Month 3 assessment
measure: Percentage of Enrollees Completing the Month 6 Assessment
timeFrame: Month 6 assessment
measure: Percentage of Weekly Pain Severity and Frequency Assessments Completed
timeFrame: Through completion of all weekly assessments, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Minnesota
name: Linda Hanson, DC, MS
role: STUDY_DIRECTOR
References: