Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A

Launched by KAROLINSKA INSTITUTET · Jan 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how botulinum toxin, commonly known for its use in cosmetic treatments, may help people with painful jaw conditions called temporomandibular disorders (TMDM). Researchers want to find out if this treatment changes the way certain genes and nerve cells in the jaw muscles behave, which might help reduce pain. The study will involve women who have specific types of jaw pain, and they will be asked to take part in questionnaires and some simple medical tests, including a small tissue sample from the jaw muscle. Participants will either receive botulinum toxin or a harmless salt solution, and follow-ups will occur at one, three, and six months to see how their pain changes.

To be eligible for this trial, participants must be women with a specific type of muscle pain in the jaw, have a certain level of pain, and be using effective birth control. They cannot have certain health conditions, like widespread pain or severe psychiatric issues, and must not be pregnant or nursing. Throughout the study, participants will have their pain levels and muscle responses carefully monitored to see if the treatment works and how it affects their daily lives.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • a diagnosis of TMDM myalgia or myofascial pain according to the DC/TMD criteria
• • females with adequate contraceptives and a negative pregnancy test
• • pain upon digital palpation of at least one of the masseter muscle
• • a characteristic pain intensity of \> 40/100
• • a negative pregnancy test at the day of treatment
• Exclusion Criteria:
• • difficulties understanding the Swedish language
• • systemic inflammatory connective tissue diseases
• • widespread pain
• • neuromuscular disorders
• • diagnosed or severe psychiatric disease
• • neuropathic pain
• • pain of dental origin
• • history of trauma to the face, head or neck
• • pregnancy or nursing
• • known allergy to botulinum toxin or antibiotics
• • use of muscle relaxants, antidepressant, neuropsychiatric, anticoagulant drugs, or aminoglycoside antibiotics
• • previous treatment with botulinum toxin during the last 12 months
• • use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy
• • skin infection over injection/biopsy site