Comparative Effectiveness of Acute Low Back Pain Management
Completed · Not applicable
Conditions studied: Low Back Pain
In brief
Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.
Key facts
- Study ID
- NCT01726803
- Run by
- University of Utah
- People needed
- 220
- Starts
- 2011-04-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2018-10-09
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region.
- Age 18 - 60 years
- Oswestry disability score > 20%
- Both of the following clinical decision rule criteria: a)Duration of current symptoms < 16 days; and b)Patient report of no symptoms (pain, numbness, etc.) distal to the knee in past 72 hours.
You may not qualify if…
- Prior surgery to the lumbosacral spine
- Any treatment for low back pain in past 6 months
- Current pregnancy
- Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.)
- Presence of neurogenic LBP defined as the presence of either of the following:
- a) Positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at <45 degrees); or b)Reflex, sensory, or strength deficits in a pattern consistent with lumbar nerve root compression
- Judgment of the primary care provider of "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection or systemic disease
Where it is running
- Intermountain Health Care — Salt Lake City, Utah, United States
- The University of Utah Healthcare System — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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