OBJECTIVE

To evaluate the efficacy, safety, tolerability and pharmacokinetics of cyclobenzaprine in patients with abnormal muscle hypertonicity following nonspecific neck and lower back pain.

MATERIAL AND METHODS

A single-blind placebo-controlled multiple-center randomized study included 240 patients randomized into 2 groups by 120 people: the main group — cyclobenzaprine 10 mg 3 times a day for 14 days; the control group — placebo (1 tablet 3 times a day). Patients could take ibuprofen at a dose not exceeding 1200 mg daily as on-demand therapy. Steady-state cyclobenzaprine pharmacokinetics parameters were assessed in 18 patients of the main group.

RESULTS

Considering pain intensity, muscle spasm, soreness and ODI score, we can conclude higher efficiency of treatment in the main group compared to placebo. Cyclobenzaprine significantly reduces the need for additional intake of NSAIDs. Steady-state cyclobenzaprine Cmax,ss, Tmax,ss, AUC0-τ,ss were analyzed. There were mild-to-moderate adverse events in the main group with subsequent recovery in 72.50% of cases. There were no significant between-group differences in severity of adverse events.

CONCLUSION

Cyclobenzaprine is effective and safe for nonspecific neck and lower back pain accompanied by muscle hypertonicity.