Who is sponsoring NCT02646124?

NCT02646124 is sponsored by Montefiore Medical Center.

What condition does NCT02646124 study?

NCT02646124 studies Low Back Pain.

What drugs are being tested in NCT02646124?

Interventions: Naproxen, Placebo, Diazepam.

What is the status of NCT02646124?

NCT02646124 is currently COMPLETED.

Last reviewed 2018-07-04 · How we verify

Adding Diazepam to Standard Management of Acute, Non-radicular Low Back Pain. An Emergency Department Based Randomized Comparative Effectiveness Study

NCT02646124 Phase 2/Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Montefiore Medical Center
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	114
Start date	2015-06
Completion	2016-05

Conditions

Low Back Pain

Interventions

Naproxen
Placebo
Diazepam

Primary outcomes

Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire — Between baseline and one week after emergency department discharge
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score.

Countries

United States