Clinical trial NCT02391350: Management Strategies for Patients With Low Back Pain and Sciatica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Sciatica
Physical Therapy
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-03-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Low back pain (LBP) is a common and costly condition. When accompanied by sciatica, risks for persistent disability and future invasive treatments increase. Most patients with LBP and sciatica enter the healthcare system in primary care. Optimal primary care management is currently unclear and little data are available to assist clinicians and inform patients of the likely effects of common options. Practice guidelines agree that imaging, spinal injections and surgeries should be reserved for patients whose symptoms do not diminish within 4-8 weeks, yet utilization rates for these procedures are increasing rapidly, partly due to the uncertainty of what options may be offered to patients for initial treatment. Physical therapy is considered an option in the initial management period, but is used inconsistently. It is currently unclear what can be expected from early physical therapy for patients with LBP and sciatica, and what if any long-term effect it may have on clinical outcomes or future healthcare utilization. The investigators research team has conducted a series of clinical trials to clarify the evidence for the most effective physical therapy procedures for patients with LBP and sciatica, and is now in a position to evaluate if the use of early, evidence-based physical therapy can reduce the risk of future disability, healthcare utilization and costs. The proposed study is a randomized trial comparing the effectiveness of usual, guideline-based initial management of newly consulting patients with LBP with sciatica with or without the addition of early physical therapy. Specific aims are to compare the clinical effectiveness, costs (direct and indirect), and cost-effectiveness of the addition of physical therapy. All patients will be managed with advice, education and medication. One group will also receive 6-8 sessions of physical therapy Outcomes will include measures of disability, pain, psychological distress, healthcare, utilization, and costs over 1 year. This study will permit an examination of the effectiveness and costs associated with the use of early physical therapy within primary care for patients with acute LBP and sciatica. The results of this study will provide needed information to assist clinicians and inform patients of their options for initial management of this common condition.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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)
3. Current symptoms present for 90 days or fewer
4. Oswestry disability score \> 20%
5. 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:

1. Any prior spine fusion surgery, or any surgery to the lumbosacral spine in the past year
2. Current pregnancy
3. 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.
4. 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

Primary outcomes:
measure: Change From Baseline in Oswestry Disability Index
timeFrame: Baseline, 4 weeks, 6 months, 1 year
Secondary outcomes:
measure: Change From Baseline in Numeric Pain Ratings
timeFrame: Baseline, 4 weeks, 6 months, 1 year
measure: Change From Baseline in EQ-5D
timeFrame: Baseline, 4 weeks, 6 months, 1 year
Other outcomes:
measure: Change From Baseline in Fear-Avoidance Beliefs
timeFrame: Baseline, 4 weeks, 6 months, 1 year
measure: Change From Baseline in Pain Catastrophizing Scale
timeFrame: Baseline, 4 weeks, 6 months, 1 year
measure: Number of Participants Utilizing Healthcare
timeFrame: monthly throughout 12 month follow-up period
Locations:
city: Salt Lake City
country: United States
facility: The University of Utah Healthcare System
state: Utah
Study officials:
References:
citation: Fritz JM, Lane E, McFadden M, Brennan G, Magel JS, Thackeray A, Minick K, Meier W, Greene T. Physical Therapy Referral From Primary Care for Acute Back Pain With Sciatica : A Randomized Controlled Trial. Ann Intern Med. 2021 Jan;174(1):8-17. doi: 10.7326/M20-4187. Epub 2020 Oct 6.