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

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 |
- 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
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- neck pain within 24 hours of injury
Exclusion Criteria:
- Children, allergy or contraindication to any of the study drugs

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
United States, New York | |
Stony Brook University | |
Stony Brook, New York, United States, 11733 |
Principal Investigator: | adam singer, md | Stony Brook University |
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 |
Cervical strain whiplash ibuprofen cyclobenzaprine |
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 |