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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:

Pain

Use of Rescue Medications

Secondary outcome:

Time to Resumption of Work

Resumption 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

Page last updated: August 23, 2015

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