Status:
RECRUITING
Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
Lead Sponsor:
Region Stockholm
Conditions:
Temporomandibular Disorder
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
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 a...
Detailed Description
The primary goal with this study is to expand treatment modalities for patient with myogenous TMD, and to develop clinical protocols with adequate doses for myogenous TMD. A secondary goal is to study...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06941636
Start Date
May 1 2025
End Date
December 1 2026
Last Update
April 24 2025
Active Locations (1)
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1
Eastman institute Folktandvården Region Stockholm
Stockholm, Sweden, 11324