Trial Outcomes & Findings for A Randomized Study of Three Medication Regimens for Acute Low Back Pain (NCT NCT01587274)

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

PHASE4

Target enrollment

323 participants

Primary outcome timeframe

Baseline and one week after discharge from emergency department

Results posted on

2018-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	Opioid Naproxen + opioid Naproxen: Naproxen 500mg twice/ day x 10 days Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days	Skeletal Muscle Relaxant Naproxen + skeletal muscle relaxant Naproxen: Naproxen 500mg twice/ day x 10 days Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days	Naproxen Alone Naproxen + placebo Naproxen: Naproxen 500mg twice/ day x 10 days
Overall Study STARTED	108	108	107
Overall Study COMPLETED	104	103	104
Overall Study NOT COMPLETED	4	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Opioid Naproxen + opioid Naproxen: Naproxen 500mg twice/ day x 10 days Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days	Skeletal Muscle Relaxant Naproxen + skeletal muscle relaxant Naproxen: Naproxen 500mg twice/ day x 10 days Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days	Naproxen Alone Naproxen + placebo Naproxen: Naproxen 500mg twice/ day x 10 days
Overall Study Lost to Follow-up	4	5	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Opioid n=108 Participants Naproxen + opioid Naproxen: Naproxen 500mg twice/ day x 10 days Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days	Skeletal Muscle Relaxant n=108 Participants Naproxen + skeletal muscle relaxant Naproxen: Naproxen 500mg twice/ day x 10 days Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days	Naproxen Alone n=107 Participants Naproxen + placebo Naproxen: Naproxen 500mg twice/ day x 10 days	Total n=323 Participants Total of all reporting groups
Age, Continuous	39 years STANDARD_DEVIATION 11 • n=108 Participants	38 years STANDARD_DEVIATION 11 • n=108 Participants	39 years STANDARD_DEVIATION 11 • n=107 Participants	39 years STANDARD_DEVIATION 11 • n=323 Participants
Sex: Female, Male Female	60 Participants n=108 Participants	45 Participants n=108 Participants	53 Participants n=107 Participants	158 Participants n=323 Participants
Sex: Female, Male Male	48 Participants n=108 Participants	63 Participants n=108 Participants	54 Participants n=107 Participants	165 Participants n=323 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	108 participants n=108 Participants	108 participants n=108 Participants	107 participants n=107 Participants	323 participants n=323 Participants
Pre-existing functional impairment as measured by the Roland Morris Disability Questionnaire	20 units on a scale n=108 Participants	19 units on a scale n=108 Participants	20 units on a scale n=107 Participants	20 units on a scale n=323 Participants

PRIMARY outcome

Timeframe: Baseline and one week after discharge from emergency department

Population: Multiple imputation used to account for participants lost to follow-up

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	Opioid n=108 Participants Naproxen + opioid Naproxen: Naproxen 500mg twice/ day x 10 days Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days	Skeletal Muscle Relaxant n=108 Participants Naproxen + skeletal muscle relaxant Naproxen: Naproxen 500mg twice/ day x 10 days Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days	Naproxen Alone n=107 Participants Naproxen + placebo Naproxen: Naproxen 500mg twice/ day x 10 days
Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire	5 units on a scale Interval 0.0 to 15.0	4 units on a scale Interval 0.0 to 16.0	7 units on a scale Interval 0.0 to 18.0

Adverse Events

Opioid

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Skeletal Muscle Relaxant

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Naproxen Alone

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Opioid n=108 participants at risk Naproxen + opioid Naproxen: Naproxen 500mg twice/ day x 10 days Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days	Skeletal Muscle Relaxant n=108 participants at risk Naproxen + skeletal muscle relaxant Naproxen: Naproxen 500mg twice/ day x 10 days Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days	Naproxen Alone n=107 participants at risk Naproxen + placebo Naproxen: Naproxen 500mg twice/ day x 10 days
Gastrointestinal disorders Nausea/ vomiting	17.6% 19/108	3.7% 4/108	5.6% 6/107
Nervous system disorders Drowsiness	14.8% 16/108	6.5% 7/108	3.7% 4/107
Nervous system disorders Dizziness	14.8% 16/108	6.5% 7/108	3.7% 4/107
Gastrointestinal disorders Stomach irritation	6.5% 7/108	6.5% 7/108	4.7% 5/107
Investigations Other	0.00% 0/108	10.2% 11/108	2.8% 3/107

Additional Information

Benjamin W. Friedman, MD

Montefiore Health

Phone: 7189206626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place