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Trial record 28 of 46 for:    CYCLOBENZAPRINE

A Randomized Study of Three Medication Regimens for Acute Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01587274
Recruitment Status : Completed
First Posted : April 30, 2012
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Low Back Pain
Interventions Drug: Naproxen
Drug: Cyclobenzaprine
Drug: Oxycodone/ acetaminophen
Enrollment 323
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Opioid Skeletal Muscle Relaxant Naproxen Alone
Hide Arm/Group Description

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

Naproxen + skeletal muscle relaxant

Naproxen: Naproxen 500mg twice/ day x 10 days

Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days

Naproxen + placebo

Naproxen: Naproxen 500mg twice/ day x 10 days

Period Title: Overall Study
Started 108 108 107
Completed 104 103 104
Not Completed 4 5 3
Reason Not Completed
Lost to Follow-up             4             5             3
Arm/Group Title Opioid Skeletal Muscle Relaxant Naproxen Alone Total
Hide Arm/Group Description

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

Naproxen + skeletal muscle relaxant

Naproxen: Naproxen 500mg twice/ day x 10 days

Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days

Naproxen + placebo

Naproxen: Naproxen 500mg twice/ day x 10 days

Total of all reporting groups
Overall Number of Baseline Participants 108 108 107 323
Hide Baseline Analysis Population Description
Patients enrolled and randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 108 participants 107 participants 323 participants
39  (11) 38  (11) 39  (11) 39  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 108 participants 107 participants 323 participants
Female
60
  55.6%
45
  41.7%
53
  49.5%
158
  48.9%
Male
48
  44.4%
63
  58.3%
54
  50.5%
165
  51.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 108 participants 108 participants 107 participants 323 participants
108 108 107 323
Pre-existing functional impairment as measured by the Roland Morris Disability Questionnaire   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 108 participants 107 participants 323 participants
20
(17 to 22)
19
(17 to 21)
20
(17 to 21)
20
(17 to 21)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire
Hide Description 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.
Time Frame Baseline and one week after discharge from emergency department
Hide Outcome Measure Data
Hide Analysis Population Description
Multiple imputation used to account for participants lost to follow-up
Arm/Group Title Opioid Skeletal Muscle Relaxant Naproxen Alone
Hide Arm/Group Description:

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

Naproxen + skeletal muscle relaxant

Naproxen: Naproxen 500mg twice/ day x 10 days

Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days

Naproxen + placebo

Naproxen: Naproxen 500mg twice/ day x 10 days

Overall Number of Participants Analyzed 108 108 107
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(0 to 15)
4
(0 to 16)
7
(0 to 18)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Opioid Skeletal Muscle Relaxant Naproxen Alone
Hide Arm/Group Description

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

Naproxen + skeletal muscle relaxant

Naproxen: Naproxen 500mg twice/ day x 10 days

Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days

Naproxen + placebo

Naproxen: Naproxen 500mg twice/ day x 10 days

All-Cause Mortality
Opioid Skeletal Muscle Relaxant Naproxen Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Opioid Skeletal Muscle Relaxant Naproxen Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/108 (0.00%)   0/107 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Opioid Skeletal Muscle Relaxant Naproxen Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/108 (39.81%)   36/108 (33.33%)   22/107 (20.56%) 
Gastrointestinal disorders       
Nausea/ vomiting *  19/108 (17.59%)  4/108 (3.70%)  6/107 (5.61%) 
Stomach irritation *  7/108 (6.48%)  7/108 (6.48%)  5/107 (4.67%) 
Investigations       
Other *  0/108 (0.00%)  11/108 (10.19%)  3/107 (2.80%) 
Nervous system disorders       
Drowsiness *  16/108 (14.81%)  7/108 (6.48%)  4/107 (3.74%) 
Dizziness *  16/108 (14.81%)  7/108 (6.48%)  4/107 (3.74%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Benjamin W. Friedman, MD
Organization: Montefiore Health
Phone: 7189206626
EMail: befriedm@montefiore.org
Layout table for additonal information
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01587274     History of Changes
Other Study ID Numbers: 11-10-379
First Submitted: April 26, 2012
First Posted: April 30, 2012
Results First Submitted: April 15, 2018
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018