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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00790270
First Posted: November 13, 2008
Last Update Posted: November 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stony Brook University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Pain [ Time Frame: Daily for 1 week ]
  • Use of Rescue Medications [ Time Frame: 24 hours ]
    the number of patients taking additional rescue medications beyond the study meds


Secondary Outcome Measures:
  • Time to Resumption of Work [ Time Frame: 1 week ]
  • Resumption of Work or School [ Time Frame: next day ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Adam Singer, MD, Stony Brook University
ClinicalTrials.gov Identifier: NCT00790270     History of Changes
Other Study ID Numbers: SB2003-1234
First Submitted: November 12, 2008
First Posted: November 13, 2008
Results First Submitted: October 19, 2009
Results First Posted: November 21, 2012
Last Update Posted: November 21, 2012
Last Verified: October 2012

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents