N/A
N=220
Management Strategies for Patients With Low Back Pain and Sciatica
Low Back Pain · Sciatica · Physical Therapy
Bottom Line
View on ClinicalTrials.gov: NCT02391350 ↗Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change From Baseline in Oswestry Disability Index — -8.8; -17.0; -17.0; -22.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education and re-assurance (Behavioral); Physical Therapy (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Oswestry Disability Index |
-8.8; -17.0; -17.0; -22.4; -17.7; -22.5 | — |
| SECONDARY Change From Baseline in Numeric Pain Ratings |
-1.0; -2.4; -1.5; -2.3; -1.6; -2.6 | — |
| SECONDARY Change From Baseline in EQ-5D |
0.05; 0.12; 0.14; 0.15; 0.13; 0.17 | — |
Summary
Low back pain and sciatica is a common condition resulting in high costs and disability for society and affected individuals. Presently there is a lack of evidence for what treatments may help this condition early in the course of care. Improved early management could reduce risks for persistent disability and high costs. The goal of this project is to examine the clinical outcomes and costs associated with adding a physical therapy program to early management of patients with low back pain and sciatica within primary care.
Eligibility Criteria
Inclusion Criteria
- Symptoms of pain and/or numbness between the 12th rib and buttocks, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region.
- Symptoms of pain and/or numbness primarily into one leg that have extended below the knee in the last 72 hours, and correspond to a lower lumbar nerve root distribution (L4, L5, S1)
- Current symptoms present for 90 days or fewer
- Oswestry disability score > 20%
- One or more of the following symptoms:
- Positive ipsilateral or contralateral straight leg raise test (reproduction of symptoms at <70 degrees)
- Reflex, sensory, or strength deficits in a pattern consistent with lower lumbar nerve root
Exclusion Criteria
- Any prior spine fusion surgery, or any surgery to the lumbosacral spine in the past year
- Current pregnancy
- Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.) or any treatment for LBP in prior 6 months.
- Judgment of primary care provider of "red flags" of a potentially serious condition including cauda equina, major or rapidly progressing neurologic deficit, fracture, cancer, infection or systemic disease
Data sourced from ClinicalTrials.gov (NCT02391350). 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.