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

October 22, 2012 updated by: Stony Brook University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11733
        • Stony Brook University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • neck pain within 24 hours of injury

Exclusion Criteria:

  • Children, allergy or contraindication to any of the study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ibuprofen
Drug: Ibuprofen
Ibuprofen 400 mg every 8 hours as needed
Other Names:
  • motrin, advil
Active Comparator: Cyclobenzaprine
Drug: Cyclobenzaprine
5 mg orally every 8 hours as needed
Other Names:
  • flexeril
Experimental: Ibuprophen plus Cyclobenzaprine
Drug: Ibuprofen plus Cyclobenzaprine
Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
Other Names:
  • motrin or advil with flexeril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Daily for 1 week
Daily for 1 week
Use of Rescue Medications
Time Frame: 24 hours
the number of patients taking additional rescue medications beyond the study meds
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Resumption of Work
Time Frame: 1 week
1 week
Resumption of Work or School
Time Frame: next day
number of patients resuming regular activity the day following enrollment.
next day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

November 21, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB2003-1234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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