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

This study has been completed.
Sponsor:
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00790270
First received: November 12, 2008
Last updated: October 22, 2012
Last verified: October 2012

November 12, 2008
October 22, 2012
January 2003
January 2004   (final data collection date for primary outcome measure)
  • 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
Pain [ Time Frame: Daily for 1 week ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00790270 on ClinicalTrials.gov Archive Site
  • 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.
Time to resumption of work [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cervical Strain
  • Drug: Cyclobenzaprine
    5 mg orally every 8 hours as needed
    Other Name: flexeril
  • Drug: Ibuprofen
    Ibuprofen 400 mg every 8 hours as needed
    Other Name: motrin, advil
  • Drug: Ibuprofen plus Cyclobenzaprine
    Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
    Other Name: motrin or advil with flexeril
  • Active Comparator: Cyclobenzaprine
    Intervention: Drug: Cyclobenzaprine
  • Active Comparator: Ibuprofen
    Intervention: Drug: Ibuprofen
  • Experimental: Ibuprophen plus Cyclobenzaprine
    Intervention: Drug: Ibuprofen plus Cyclobenzaprine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
January 2004
January 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • neck pain within 24 hours of injury

Exclusion Criteria:

  • Children, allergy or contraindication to any of the study drugs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00790270
SB2003-1234
No
Adam Singer, MD, Stony Brook University
Stony Brook University
Not Provided
Principal Investigator: adam singer, md Stony Brook University
Stony Brook University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP