Back to resultsComparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Primary Purpose
Cervical Strain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclobenzaprine
Ibuprofen
Ibuprofen plus Cyclobenzaprine
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Strain focused on measuring Cervical strain, whiplash, ibuprofen, cyclobenzaprine
Eligibility Criteria
Inclusion Criteria:
- neck pain within 24 hours of injury
Exclusion Criteria:
- Children, allergy or contraindication to any of the study drugs
Sites / Locations
- Stony Brook University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Cyclobenzaprine
Ibuprofen
Ibuprophen plus Cyclobenzaprine
Arm Description
Outcomes
Primary Outcome Measures
Pain
Use of Rescue Medications
the number of patients taking additional rescue medications beyond the study meds
Secondary Outcome Measures
Time to Resumption of Work
Resumption of Work or School
number of patients resuming regular activity the day following enrollment.
Full Information
NCT ID
NCT00790270
First Posted
November 12, 2008
Last Updated
October 22, 2012
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT00790270
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Strain
Keywords
Cervical strain, whiplash, ibuprofen, cyclobenzaprine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cyclobenzaprine
Arm Type
Active Comparator
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Title
Ibuprophen plus Cyclobenzaprine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cyclobenzaprine
Other Intervention Name(s)
flexeril
Intervention Description
5 mg orally every 8 hours as needed
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
motrin, advil
Intervention Description
Ibuprofen 400 mg every 8 hours as needed
Intervention Type
Drug
Intervention Name(s)
Ibuprofen plus Cyclobenzaprine
Other Intervention Name(s)
motrin or advil with flexeril
Intervention Description
Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
Primary Outcome Measure Information:
Title
Pain
Time Frame
Daily for 1 week
Title
Use of Rescue Medications
Description
the number of patients taking additional rescue medications beyond the study meds
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time to Resumption of Work
Time Frame
1 week
Title
Resumption of Work or School
Description
number of patients resuming regular activity the day following enrollment.
Time Frame
next day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
neck pain within 24 hours of injury
Exclusion Criteria:
Children, allergy or contraindication to any of the study drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
adam singer, md
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11733
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
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