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

Recruiting now · Phase 3

Conditions studied: Temporomandibular Disorder

In brief

Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent. The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent.

Key facts

Study ID

NCT06941636

Run by

Region Stockholm

People needed

90

Starts

2025-05-01

Expected to finish

2026-12-01

Last updated by the study team

2025-04-24

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Eastman institute Folktandvården Region Stockholm — Stockholm, Sweden (enrolling)

Full record on ClinicalTrials.gov

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