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

Stony Brook University

Status and phase: Completed; Phase 2

Conditions: Cervical Strain

Treatments: Drug: Ibuprofen; Drug: Cyclobenzaprine; Drug: Ibuprofen plus Cyclobenzaprine

Study type: Interventional

Funder types: Other

Identifiers

NCT00790270

SB2003-1234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• neck pain within 24 hours of injury

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

61 participants in 3 patient groups

Cyclobenzaprine

Active Comparator group

Treatment:

Drug: Cyclobenzaprine

Ibuprofen

Active Comparator group

Treatment:

Drug: Ibuprofen

Ibuprophen plus Cyclobenzaprine

Experimental group

Treatment:

Drug: Ibuprofen plus Cyclobenzaprine