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

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:

Drug Information available for: Cyclobenzaprine Cyclobenzaprine hydrochloride Ibuprofen Ibuprofen sodium Ibuprofen lysine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on February 27, 2015