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Completed

NCT Number: NCT00790270

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

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.

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Key information

Conditions

Cervical Strain Neck Injuries Whiplash Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stony Brook University

Stony Brook, New York, 11733, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • neck pain within 24 hours of injury

Exclusion criteria

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

Treatment and study plan

Cyclobenzaprine

Drug

5 mg orally every 8 hours as needed

Other names: flexeril

Ibuprofen

Drug

Ibuprofen 400 mg every 8 hours as needed

Other names: motrin, advil

Ibuprofen plus Cyclobenzaprine

Drug

Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed

Other names: motrin or advil with flexeril

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Nov 13, 2008
Registry last updated
Nov 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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