Diazepam Use With Standard Management for Acute Low Back Pain

NCT02646124 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2015-4639
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

benzodiazepine

Outcome Measures

Primary Outcomes (1)

• Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire

  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.

  Between baseline and one week after emergency department discharge

Secondary Outcomes (4)

• Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale

  1 week after discharge from emergency department

• Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours

  One week after discharge from the emergency department

• Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 72 Hours

  Assessed three months after emergency department discharge

• Participants Satisfied With Treatment

  1 week

Study Arms (2)

Diazepam

EXPERIMENTAL

Naproxen +Diazepam

Drug: Naproxen; Drug: Diazepam

Placebo

ACTIVE COMPARATOR

Naproxen + Placebo

Drug: Naproxen; Drug: Placebo

Interventions

Naproxen DRUG

Naproxen 500mg by mouth two times a day, #20

Diazepam; Placebo

Placebo DRUG

28 placebo capsules

Also known as: Placebo Diazepam

Placebo

Diazepam DRUG

Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28

Diazepam

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Naproxen; Diazepam

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Benjamin W. Friedman, MD, MS
• Organization: Montefiore Medical Center

befriedm@montefiore.org

(718)920-6266

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: January 5, 2016
• Study Start: June 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 1, 2018
• Results First Posted: July 3, 2018

Record last verified: 2018-07

Locations

US (1)