drugset / Trial / NCT04426123

Masseter Myofascial Pain Relief Following an Intra-muscular Injection With Botulinum Toxin Type A.

NCT04426123

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Investigating the effect of a single intramuscular injection with botulinum toxin (BTX) compared to NaCl in patients with jaw muscle myalgia. This investigation is designed as an double blind multicenter pilot study for hypothesis generation on 48 patients with chronic jaw muscle myalgia at four specialist dental clinics. The subjects visit the clinic on 3 predefined occasions, one telephone call and one scheduled evaluation by mail. The objective is primarily to evaluate the change in number of days with pain at two months following one session of BTX injections of the masseter and temporalis muscles in subjects with jaw muscle myalgia pain. The outcome of this study will serve as a basis for a later randomized controlled trial

Timeline

Start
2020-07-01
Primary completion
2020-12-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic Intramuscular