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Diazepam Use With Standard Management for Acute Low Back Pain

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Naproxen

Placebo

Diazepam

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring benzodiazepine

Eligibility Criteria

21 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diazepam

Placebo

Arm Description

Naproxen +Diazepam

Naproxen + Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Patients with moderate or serve pain. Worst Lower Back Pain (LBP) over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.

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

Telephone questionnaire is used to assess patients needing any analgesic or low back pain medication within the previous 24 hours.

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

Patients needing any analgesic or LBP medication within the previous 72 hours

Participants Satisfied With Treatment

Participants who answered "Yes" when asked the question "Do you want to receive the same combination of medications during a subsequent visit to the ER?"

Full Information

NCT ID

NCT02646124

First Posted

December 31, 2015

Last Updated

July 4, 2018

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02646124

Brief Title

Diazepam Use With Standard Management for Acute Low Back Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

benzodiazepine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diazepam

Arm Type

Experimental

Arm Description

Naproxen +Diazepam

Arm Title

Placebo

Arm Type

Active Comparator

Arm Description

Naproxen + Placebo

Intervention Type

Drug

Intervention Name(s)

Naproxen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo Diazepam

Intervention Description

28 placebo capsules

Intervention Type

Drug

Intervention Name(s)

Diazepam

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Between baseline and one week after emergency department discharge

Secondary Outcome Measure Information:

Title

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

Description

Patients with moderate or serve pain. Worst Lower Back Pain (LBP) over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.

Time Frame

1 week after discharge from emergency department

Title

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

Description

Telephone questionnaire is used to assess patients needing any analgesic or low back pain medication within the previous 24 hours.

Time Frame

One week after discharge from the emergency department

Title

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

Description

Patients needing any analgesic or LBP medication within the previous 72 hours

Time Frame

Assessed three months after emergency department discharge

Title

Participants Satisfied With Treatment

Description

Participants who answered "Yes" when asked the question "Do you want to receive the same combination of medications during a subsequent visit to the ER?"

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

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 <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

Facility Information:

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

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Diazepam Use With Standard Management for Acute Low Back Pain

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