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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
History of Changes
  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 Intervention Phase
Cervical Strain
 Drug: Cyclobenzaprine
Drug: Ibuprofen
Drug: Ibuprofen plus Cyclobenzaprine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stony Brook University:

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


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.


Enrollment: 61
Study Start Date: January 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cyclobenzaprine Drug: Cyclobenzaprine
5 mg orally every 8 hours as needed
Other Name: flexeril
Active Comparator: Ibuprofen Drug: Ibuprofen
Ibuprofen 400 mg every 8 hours as needed
Other Name: motrin, advil
Experimental: Ibuprophen plus Cyclobenzaprine Drug: Ibuprofen plus Cyclobenzaprine
Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
Other Name: motrin or advil with flexeril

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neck pain within 24 hours of injury

Exclusion Criteria:

  • Children, allergy or contraindication to any of the study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790270

Locations
United States, New York
Stony Brook University
Stony Brook, New York, United States, 11733
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: adam singer, md Stony Brook University
  More Information

No publications provided

Responsible Party: Adam Singer, MD, Stony Brook University
ClinicalTrials.gov Identifier: NCT00790270     History of Changes
Other Study ID Numbers: SB2003-1234
Study First Received: November 12, 2008
Results First Received: October 19, 2009
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
Cervical strain
whiplash
ibuprofen
cyclobenzaprine

Additional relevant MeSH terms:
Sprains and Strains
Wounds and Injuries
Ibuprofen
Amitriptyline
Cyclobenzaprine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
 Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013