Phase 3
N=114
Diazepam Use With Standard Management for Acute Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02646124 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire — 11; 11 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Naproxen (Drug); Placebo (Drug); Diazepam (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire |
11; 11 | — |
| SECONDARY Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale |
18; 12 | — |
| SECONDARY Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours |
26; 25 | — |
| SECONDARY Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 72 Hours |
— | — |
| SECONDARY Participants Satisfied With Treatment |
44; 37 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02646124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.