Cyclobenzaprine 5 mg versus cyclobenzaprine 5 mg plus ibuprofen for spasm and pain of the back and neck

Abstract

Acute musculoskeletal spasm and pain is a leading cause of physician visits and disability in people under 45 years of age. This community-based study compared therapeutic outcomes obtained when patients with acute musculoskeletal spasm and pain of the back or neck were treated with cyclobenzaprine 5 mg tid (Cyc5)(Flexeril®) alone or in combination with ibuprofen 400 mg tid (Cyc5/Ibu400) or ibuprofen 800 mg tid (Cyc5/Ibu800). A prospective, randomized, open-label, multi-center, 7-day study was conducted to compare Cyc5, Cyc5/Ibu400, and Cyc5/Ibu800 in patients 18–65 years of age with acute muscle spasm of the back and/or neck. Patient Global Impression of Change (PGIC; 0=worsening to 4=marked improvement) was the primary endpoint. The mean Oswestry Disability Index (ODI; calculated from the 10 section scores and normalized to 100) served as a secondary endpoint. Data were collected via an Interactive Voice Recognition System after 3 and 7 days of therapy. Patients (N=867) completing up to 7 days of therapy were assessed. The mean PGIC scores showed improvements after Day 3 (Cyc5=2.5, Cyc5/Ibu400=2.6, and Cyc5/Ibu800=2.6) and Day 7 (Cyc5=3.0, Cyc5/Ibu400=3.0, and Cyc5/Ibu800=2.9) that were comparable for each treatment group. Improvements from baseline in the mean ODI scores were also similar for each treatment group. Mean PGIC and ODI scores showed significantly (p<0.001) greater improvements after 7 days than after 3 days for all three treatments, but there were no significant differences in these scores among the 3 treatment groups on either day. The comparable improvements in PGIC and ODI observed for patients treated with Cyc5 either alone or in combination with ibuprofen (400 or 800 mg) suggest that there may be no additional benefits of taking ibuprofen if muscle relaxant therapy with Cyc5 is used for spasm and pain of the back and neck. Funded by McNeil Consumer & Specialty Pharmaceuticals.