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

Cervical Strain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790270
• Other study ID #: SB2003-1234
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2008
• Last updated: October 22, 2012
• Start date: January 2003
• Est. completion date: January 2004

Study information

• Verified date: October 2012
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• neck pain within 24 hours of injury

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Strain
• Sprains and Strains

Intervention

Drug:
• Cyclobenzaprine
5 mg orally every 8 hours as needed
• Ibuprofen
Ibuprofen 400 mg every 8 hours as needed
• Ibuprofen plus Cyclobenzaprine
Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		Daily for 1 week	No
Primary	Use of Rescue Medications	the number of patients taking additional rescue medications beyond the study meds	24 hours	No
Secondary	Time to Resumption of Work		1 week	No
Secondary	Resumption of Work or School	number of patients resuming regular activity the day following enrollment.	next day	No