Jaw muscle pain relief following local injection with Botox. A randomized double-blind controlled multicenter pilot study

Phase 1

• Conditions: Myalgia of jaw muscle; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-004704-35-SE
• Lead Sponsor: Region Örebro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-12
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified