Trial Outcomes & Findings for Diazepam Use With Standard Management for Acute Low Back Pain (NCT NCT02646124)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

114 participants

Primary outcome timeframe

Between baseline and one week after emergency department discharge

Results posted on

2018-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Diazepam Naproxen +Diazepam Naproxen: Naproxen 500mg by mouth two times a day, #20 Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28	Placebo Naproxen + Placebo Naproxen: Naproxen 500mg by mouth two times a day, #20 Placebo: 28 placebo capsules
Overall Study STARTED	57	57
Overall Study COMPLETED	57	55
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Diazepam Naproxen +Diazepam Naproxen: Naproxen 500mg by mouth two times a day, #20 Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28	Placebo Naproxen + Placebo Naproxen: Naproxen 500mg by mouth two times a day, #20 Placebo: 28 placebo capsules
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diazepam n=57 Participants Naproxen +Diazepam Naproxen: Naproxen 500mg by mouth two times a day, #20 Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day,, #28	Placebo n=57 Participants Naproxen + Placebo Naproxen: Naproxen 500mg by mouth two times a day, #20 Placebo: 28 placebo capsules	Total n=114 Participants Total of all reporting groups
Age, Continuous	34 Years STANDARD_DEVIATION 12 • n=57 Participants	38 Years STANDARD_DEVIATION 12 • n=57 Participants	36 Years STANDARD_DEVIATION 12 • n=114 Participants
Sex: Female, Male Female	27 Participants n=57 Participants	24 Participants n=57 Participants	51 Participants n=114 Participants
Sex: Female, Male Male	30 Participants n=57 Participants	33 Participants n=57 Participants	63 Participants n=114 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	57 Participants n=57 Participants	57 Participants n=57 Participants	114 Participants n=114 Participants
Duration of Back Pain Prior to Study	72 hours n=57 Participants	48 hours n=57 Participants	48 hours n=114 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diazepam n=57 Participants Naproxen +Diazepam Naproxen: Naproxen 500mg by mouth two times a day, #20 Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28	Placebo n=55 Participants Naproxen + Placebo Naproxen: Naproxen 500mg by mouth two times a day, #20 Placebo: 28 placebo capsules
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire	11 units on a scale Interval 9.0 to 13.0	11 units on a scale Interval 9.0 to 13.0

SECONDARY outcome

Timeframe: 1 week after discharge from emergency department

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.

Outcome measures

Outcome measures
Measure	Diazepam n=57 Participants Naproxen +Diazepam Naproxen: Naproxen 500mg by mouth two times a day, #20 Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28	Placebo n=55 Participants Naproxen + Placebo Naproxen: Naproxen 500mg by mouth two times a day, #20 Placebo: 28 placebo capsules
Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale	18 Participants	12 Participants

SECONDARY outcome

Timeframe: One week after discharge from the emergency department

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

Outcome measures

Outcome measures
Measure	Diazepam n=57 Participants Naproxen +Diazepam Naproxen: Naproxen 500mg by mouth two times a day, #20 Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28	Placebo n=55 Participants Naproxen + Placebo Naproxen: Naproxen 500mg by mouth two times a day, #20 Placebo: 28 placebo capsules
Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours	26 Participants	25 Participants

SECONDARY outcome

Timeframe: Assessed three months after emergency department discharge

Population: data not collected

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week

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?"

Outcome measures

Outcome measures
Measure	Diazepam n=57 Participants Naproxen +Diazepam Naproxen: Naproxen 500mg by mouth two times a day, #20 Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28	Placebo n=55 Participants Naproxen + Placebo Naproxen: Naproxen 500mg by mouth two times a day, #20 Placebo: 28 placebo capsules
Participants Satisfied With Treatment	44 Participants	37 Participants

Adverse Events

Diazepam

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diazepam n=57 participants at risk Naproxen +Diazepam Naproxen: Naproxen 500mg by mouth two times a day, #20 Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28	Placebo n=55 participants at risk Naproxen + Placebo Naproxen: Naproxen 500mg by mouth two times a day, #20 Placebo: 28 placebo capsules
Nervous system disorders Drowsy	7.0% 4/57 • Number of events 4	1.8% 1/55 • Number of events 1
Nervous system disorders Dizzy	1.8% 1/57 • Number of events 1	0.00% 0/55
Gastrointestinal disorders Stomach irritation	1.8% 1/57 • Number of events 1	1.8% 1/55 • Number of events 1
General disorders Other	10.5% 6/57 • Number of events 6	10.9% 6/55 • Number of events 6

Additional Information

Benjamin W. Friedman, MD, MS

Montefiore Medical Center

Phone: (718)920-6266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place