Comparative Effectiveness of Acute Low Back Pain Management
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Low Back Pain |
Other: Early Physical Therapy Other: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparative Effectiveness of Management Strategies for Acute Low Back Pain |
- Oswestry Disability Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]10-item Oswestry Disability Index
- Numeric Pain Rating [ Time Frame: Baseline. 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]0-10 numeric rating of low back pain intensity
- EQ-5D [ Time Frame: Baseline. 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]European Quality of Life Measure
- Fear-Avoidance Beliefs Questionnaire [ Time Frame: Baseline. 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]
- Patient Global Rating of Improvement [ Time Frame: 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]15-point patient global rating scale
- Health care utilization [ Time Frame: 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]Utilization of healthcare for low back pain
- Pain Catastrophizing [ Time Frame: Baseline. 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]13-item Pain Catastrophizing Scale
- Lost work time [ Time Frame: 4 weeks, 3 months, 12 months ] [ Designated as safety issue: No ]Number of hours of lost work productivity
| Estimated Enrollment: | 220 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Usual Care
Usual care arm will receive management as recommended by practice guidelines and directed by the primary care provider. The recommended stepped care approach is used with initial management of advice and education only and no referral to physical therapy during the initial 4 weeks.
|
Other: Early Physical Therapy
The early physical therapy arm includes 4 total sessions. The first 2 sessions include use of thrust spinal manipulation with exercises for range of motion and strengthening of the spine. The final 2 sessions include the exercise component only.
Other: Usual Care
The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress.
|
|
Experimental: Early Physical Therapy
The Early Physical Therapy arm will receive the same advice and education intervention received by the usual care group and will be referred to receive 4 sessions of physical therapy during the first 4 weeks. The physical therapy protocol involves spinal manipulation and exercise.
|
Other: Usual Care
The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Jake Magel, PT, DSc | 801-581-6861 | jake.magel@hsc.utah.edu |
| Contact: Julie M Fritz, PT, PhD | 801-581-6861 | julie.fritz@hsc.utah.edu |
| United States, Utah | |
| The University of Utah Healthcare System | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Contact: Jake Magel, PT, DSc 801-581-6861 jake.magel@hsc.utah.edu | |
| Principal Investigator: Julie M Fritz, PT, PhD | |
| Intermountain Health Care | Recruiting |
| Salt Lake City, Utah, United States, 84106 | |
| Contact: Jake Magel, PT, DSc 801-581-8681 Jake.Magel@imail.org | |
| Principal Investigator: Julie M Fritz, PT, PhD | |
| Principal Investigator: | Julie M Fritz, PT, PhD | University of Utah and Intermountain Healthcare |
More Information
No publications provided
| Responsible Party: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT01726803 History of Changes |
| Other Study ID Numbers: | 1R18HS018672 |
| Study First Received: | November 8, 2012 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Agency for Healthcare Research and Quality |
Keywords provided by University of Utah:
|
Low Back Pain Primary Care Physical Therapy |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013