A Randomized Study of Three Medication Regimens for Acute Low Back Pain
Condition: Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Naproxen; Cyclobenzaprine; Oxycodone/ acetaminophen
Intervention description: Naproxen 500mg twice/ day x 10 days; Cyclobenzaprine 5-10mg three times/ day x 10 days; Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days
Intervention MeSH terms: Acetaminophen; Naproxen; Acetaminophen, hydrocodone drug combination; Oxycodone; Cyclobenzaprine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: low back pain

Summary:

      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
    

Eligibility criteria:

        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