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

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Region Örebro County
• Collaborators: Landstinget i Värmland; Region Västmanland
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• age > 18 years

• > 3-month complaints of jaw/face pain

• the diagnose myalgia according to DC/TMD

• understands Swedish verbally and in writing

• in writing give his/her consent to participate

Exclusion Criteria:

• polyarthritis/connective tissue disease

• fibromyalgia or other generalized pain

• neurological disorders

• whiplash associated disorders

• ongoing virus or bacterial infection

• ongoing dental treatment

• botulinum toxin injection in the jaw or face past six months

• complex psychiatric/psychological profile, institutional residence

• employee at the trial clinic, internal resident

• hypersensitivity to botulinum toxin, human albumin

• serious health conditions according to the examiner's assessment

• in the presence of infection at the proposed injection site(s)

• pregnancy or lactating

• fertile women not on contraception