Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders

Launched by REGION STOCKHOLM · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether injections of Botulinumtoxin A (BTX) can help relieve pain in people with temporomandibular disorders (TMD), which often cause discomfort in the jaw and face. The researchers want to see if the amount of BTX given makes a difference in how well it works. They are looking for women aged 18 to 65 who have been experiencing pain for more than three months and have specific types of pain in the jaw muscles. Participants must also be able to understand the study and provide informed consent, meaning they agree to take part after being fully informed about the trial.

If you qualify and decide to participate, you will receive BTX injections in your jaw muscles. The study is currently recruiting participants, and those selected will be monitored to see how effective the treatment is over time. It's important to note that if you've had certain other treatments recently or have specific health conditions, you might not be eligible to join. This trial could provide valuable information on a potential new treatment for TMD pain.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Has given a written consent
• • Diagnose of myalgia, myofacial pain or myofascial pain with referred pain according
• • Average pain due to NRS ≥ 3 for more than three months
• • Palpationpain in masseter or temporalis.
• • Eventual treatment for orofacial pain \> three months ago.
• • Adequate contraceptives and a negative pregnancy test.
• • Patients will still be included even if they have one or more co-diagnoses
• • Discdisplacement with or without reduction
• • Degenerative joint disease
• • Arthralgia
• Exclusion Criteria:
• • Treatment with BTX during the last 12 months
• • Treatment for orofacial pain within the last 3 months.
• • Systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
• • Widespread pain e.g., fibromyalgia
• • Neuropathic pain
• • Neurologic disease (myasthenia gravis)
• • Pain of dental origin
• • Use of muscle relaxants, or aminoglycoside antibiotics
• • Pregnancy or nursing
• • Hypersensitivity to BTX
• • Neuropsychiatric conditions.
• • Difficulties understanding the Swedish language