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

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ClinicalTrials.gov Identifier: NCT00790270
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Information provided by:
Stony Brook University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Strain Drug: Cyclobenzaprine Drug: Ibuprofen Drug: Ibuprofen plus Cyclobenzaprine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
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
Study Start Date : January 2003
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

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Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  1. Time to Resumption of Work [ Time Frame: 1 week ]
  2. Resumption of Work or School [ Time Frame: next day ]
    number of patients resuming regular activity the day following enrollment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, New York
Stony Brook University
Stony Brook, New York, United States, 11733
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: adam singer, md Stony Brook University
More Information
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Responsible Party: Adam Singer, MD, Stony Brook University
ClinicalTrials.gov Identifier: NCT00790270    
Other Study ID Numbers: SB2003-1234
First Posted: November 13, 2008    Key Record Dates
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:
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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