Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial | RxWiki

Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.
Condition	Cervical Strain
Intervention	Drug: Cyclobenzaprine Drug: Ibuprofen Drug: Ibuprofen plus Cyclobenzaprine
Phase	Phase 2
Sponsor	Stony Brook University
Responsible Party	Stony Brook University
ClinicalTrials.gov Identifier	NCT00790270
First Received	November 12, 2008
Last Updated	October 22, 2012
Last verified	October 2012

Tracking Information[ + expand ][ + ]

First Received Date	November 12, 2008
Last Updated Date	October 22, 2012
Start Date	January 2003
Estimated Primary Completion Date	January 2004
Current Primary Outcome Measures	Pain [Time Frame: Daily for 1 week] [Designated as safety issue: No] Use of Rescue Medications [Time Frame: 24 hours] [Designated as safety issue: No]the number of patients taking additional rescue medications beyond the study meds
Current Secondary Outcome Measures	Time to Resumption of Work [Time Frame: 1 week] [Designated as safety issue: No] Resumption of Work or School [Time Frame: next day] [Designated as safety issue: No]number of patients resuming regular activity the day following enrollment.

Descriptive Information[ + expand ][ + ]

Brief Title	Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Official Title	Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Brief Summary	The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.
Detailed Description	Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Cervical Strain
Intervention	Drug: Cyclobenzaprine 5 mg orally every 8 hours as needed Other Names: flexerilDrug: Ibuprofen Ibuprofen 400 mg every 8 hours as needed Other Names: motrin, advilDrug: Ibuprofen plus Cyclobenzaprine Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed Other Names: motrin or advil with flexeril
Study Arm (s)	Active Comparator: Cyclobenzaprine Active Comparator: Ibuprofen Experimental: Ibuprophen plus Cyclobenzaprine

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	61
Estimated Completion Date	January 2004
Estimated Primary Completion Date	January 2004
Eligibility Criteria	Inclusion Criteria: - neck pain within 24 hours of injury Exclusion Criteria: - Children, allergy or contraindication to any of the study drugs
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00790270
Other Study ID Numbers	SB2003-1234
Has Data Monitoring Committee	No
Information Provided By	Stony Brook University
Study Sponsor	Stony Brook University
Collaborators	Not Provided
Investigators	Principal Investigator: adam singer, md Stony Brook University
Verification Date	October 2012

Locations[ + expand ][ + ]