Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Information source: Stony Brook University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Strain
Intervention: Cyclobenzaprine (Drug); Ibuprofen (Drug); Ibuprofen plus Cyclobenzaprine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Stony Brook University Official(s) and/or principal investigator(s): adam singer, md, Principal Investigator, Affiliation: Stony Brook University
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.
Clinical Details
Official title: Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: PainUse of Rescue Medications
Secondary outcome: Time to Resumption of WorkResumption of Work or School
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- neck pain within 24 hours of injury
Exclusion Criteria:
- Children, allergy or contraindication to any of the study drugs
Locations and Contacts
Stony Brook University, Stony Brook, New York 11733, United States
Additional Information
Starting date: January 2003
Last updated: October 22, 2012
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