Diazepam Use With Standard Management for Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Given the poor pain and functional outcomes that persist beyond an Emergency Department (ED)
      visit for musculoskeletal low back pain (LBP), we propose a clinical trial to evaluate
      whether combining a benzodiazepine with an NSAID is more effective than nonsteroidal
      antiinflammatory drug (NSAID) monotherapy for the treatment of acute, non-traumatic,
      non-radicular low back pain.
    

Detailed description: 
      Low back pain (LBP) causes 2.4% of visits to US emergency departments (ED) resulting in 2.7
      million visits annually. In general, outcomes for these patients are poor. One week after ED
      discharge, 70% of patients report persistent back-pain related functional impairment and 69%
      report analgesic use within the previous 24 hours. Three months after the ED visit, 48% of
      these patients report functional impairment, 42% report moderate or severe pain, and 46%
      report persistent analgesic use.

      It is not clear how acute LBP should be treated. Non-steroidal anti-inflammatory drugs
      (NSAID) are guideline-supported, first line therapy for acute LBP. NSAIDs are more
      efficacious than placebo with regard to pain relief, global improvement, and requirement of
      analgesic medication but are not sufficient therapy for as many as ½ of ED patients, who
      continue to suffer despite therapy with NSAIDs. Treatment of LBP with multiple concurrent
      medications is common in the ED--emergency physicians often prescribe benzodiazepines,
      skeletal muscle relaxants, or opioids in combination with NSAIDs. However, work recently
      completed here at Montefiore has revealed that combining skeletal muscle relaxants or opioids
      with NSAIDs does not improve outcomes. It remains uncertain if adding benzodiazepines to
      NSAIDs improves LBP outcomes.

      Although benzodiazepines are used in 300,000 US ED visits for LBP annually, scant evidence
      exists to determine the appropriateness of this approach. Efficacy of benzodiazepines may be
      related to direct or centrally-mediated action on skeletal muscle or may instead work by
      mitigating anxiety about the condition or numbing a patient to the pain.

      Given the poor pain and functional outcomes that persist beyond an ED visit for
      musculoskeletal LBP, we propose a clinical trial to evaluate whether combining a
      benzodiazepine with an NSAID is more effective than NSAID monotherapy for the treatment of
      acute, non-traumatic, non-radicular low back pain. Specifically, we will evaluate the
      following hypothesis:

      A daily regimen of naproxen + diazepam will provide greater relief of LBP than naproxen +
      placebo one week after an ED visit, as measured by the Roland Morris Disability
      Questionnaire.
    

Intervention name(s): Naproxen; Placebo; Diazepam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Naproxen 500mg by mouth two times a day, #20; 28 placebo capsules; Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28
Other intervention name(s): Placebo Diazepam
Intervention MeSH terms: Naproxen; Diazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: benzodiazepine