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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Adam Singer, MD, Stony Brook University
ClinicalTrials.gov Identifier:	NCT00790270 History of Changes
Other Study ID Numbers:	SB2003-1234
First Posted:	November 13, 2008
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