View Clinical Trial (Medical Research Study)
A Randomized Three-armed Comparative Effectiveness Study of Various Medications for Musculoskeletal Low Back Pain: Defining the Added Benefit of Muscle Relaxants and Opioids.
| City: |
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Bronx |
| State: |
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New York |
| Zip Code: |
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10467 |
| Conditions: |
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Acute Low Back Pain |
| Purpose: |
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Low back pain causes 2.4% of visits to US emergency departments (ED) resulting in 2.7
million visits annually. In a general low back pain (LBP) population, prognosis is poor.
About 50% of patients who visited general practitioners with new onset musculoskeletal LBP
report persistent pain and functional disability three months after the index visit.
Outcomes are similarly poor for the population of patients forced to use an ED for
management of their LBP. In an observational study of patients with non-traumatic LBP
recently completed at the PI's institution, patients were contacted one week after ED
discharge: 70% reported persistent back-pain related functional impairment, 59% reported
moderate or severe LBP, and 69% reported analgesic use within the previous 24 hours. Three
months after the ED visit, 48% reported functional impairment, 42% reported moderate or
severe pain, and 46% reported analgesic use within the previous 24 hours.
A variety of evidence-based medications are available to treat LBP. Non-steroidal
anti-inflammatory drugs (NSAID) are more efficacious than placebo with regard to pain
relief, global improvement, and requirement of analgesic medication. Skeletal
muscle-relaxants too are effective for short-term pain relief and global efficacy. Opioids
are commonly used for moderate or severe acute LBP,(9) though high-quality evidence
supporting this practice is lacking.
Treatment of LBP with multiple concurrent medications is common in the ED setting. Emergency
physicians often prescribe NSAIDs, skeletal muscle relaxants, and opioids in combination.
Several clinical trials have compared combination therapy with NSAIDS+ skeletal muscle
relaxants to monotherapy with just one of these agents. These trials have reported
heterogeneous results. The combination of opioids + NSAIDS has not been evaluated
experimentally in patients with acute LBP.
Given the poor pain and functional outcomes that persist beyond an ED visit for
musculoskeletal LBP, the investigators propose a clinical trial to evaluate whether
combining muscle relaxants or opioids with NSAIDs is more effective than NSAID monotherapy
for the treatment of non-traumatic, non-radicular low back pain. Specifically, the
investigators will evaluate three distinct hypotheses:
1. The combination of naproxen + cyclobenzaprine will provide greater relief of LBP than
naproxen alone seven days after an ED visit, as measured by the Roland Morris low back
pain functional disability scale
2. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of
LBP than naproxen alone seven days after an ED visit, as measured by the Roland Morris
low back pain functional disability scale
3. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of
LBP than naproxen + cyclobenzaprine seven days after an ED visit, as measured by the
Roland Morris low back pain functional disability scale
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Non-radicular, non-traumatic low back pain of no more than 2 weeks duration
Exclusion Criteria:
- Back pain longer than 2 weeks
- Prior to the acute attack of low back pain, back pain once per month or more
frequently
- Prior to the acute attack of low back pain, daily or near daily use of pain
medication
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| NCT ID: |
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NCT01587274 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Bronx, New York 10467
United States
Benjamin W Friedman, MD, MS
Phone: 718-920-6626
Email: befriedm@montefiore.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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