Diazepam Use With Standard Management for Acute Low Back Pain

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.

Inclusion Criteria:

- Present to ED primary for management of LBP, defined as pain originating between the
lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain
originating from tissues lateral to the paraspinal muscles, will not be included.

- Absence of non-musculoskeletal etiology of low back, such as urinary tract infection,
cystic ovarian disease, or influenza like illness. The primary clinical diagnosis, at
the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic,
non-radicular, musculoskeletal LBP.

- Patient is to be discharged home. Patients admitted to the hospital are more likely to
be treated with parenteral medication and therefore are not appropriate for this
study.

- Age 21-69 Enrollment will be limited to adults younger than 70 years because of the
increased risk of adverse medication effects in the elderly.

- Non-radicular pain: pain cannot radiate below the gluteal folds in a radicular
pattern. Patients with non-radicular pain extending below the gluteal folds will not
be excluded

- Pain duration <2 weeks (336 hours). Patients with more than two weeks of pain are at
increased risk of poor pain and functional outcomes.(2)

- Prior to the acute attack of LBP, back pain cannot have occurred once per month or
more frequently. Patients with more frequent back pain are at increased risk of poor
pain and functional outcomes.(2)

- Non-traumatic LBP: no substantial and direct trauma to the back within the previous
month

- Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris
Disability Questionnaire

Exclusion Criteria:

- -Not available for follow-up

- Pregnant or breast-feeding

- Chronic pain syndrome defined as use of any analgesic medication on a daily or
near-daily basis

- Allergic to or intolerant of investigational medications

- Contra-indications to non-steroidal anti-inflammatory drugs: peptic ulcer disease,
history of gastro-intestinal bleeding, congestive heart failure, advanced renal
disease, aspirin sensitive asthma

- Contra-indications to diazepam: glaucoma, myasthenia gravis, cirrhosis, sleep apnea,
history of alcoholism or substance abuse