MedPath

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

Phase 2
Completed
Conditions
Cervical Strain
Interventions
Registration Number
NCT00790270
Lead Sponsor
Stony Brook University
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
61
Inclusion Criteria
  • neck pain within 24 hours of injury
Exclusion Criteria
  • Children, allergy or contraindication to any of the study drugs

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IbuprofenIbuprofen-
Ibuprophen plus CyclobenzaprineIbuprofen plus Cyclobenzaprine-
CyclobenzaprineCyclobenzaprine-
Primary Outcome Measures
NameTimeMethod
PainDaily for 1 week
Use of Rescue Medications24 hours

the number of patients taking additional rescue medications beyond the study meds

Secondary Outcome Measures
NameTimeMethod
Time to Resumption of Work1 week
Resumption of Work or Schoolnext day

number of patients resuming regular activity the day following enrollment.

Trial Locations

Locations (1)

Stony Brook University

🇺🇸

Stony Brook, New York, United States

© Copyright 2025. All Rights Reserved by MedPath