Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A
Recruiting now · Phase 2
Conditions studied: Temporomandibular Disorders
In brief
The goal of this clinical trial is to investigate the effect of botulinum toxin on neurons' plasticity in the masseter muscle in humans with and without painful myogenous temporomandibular disorders (TMDM). The main questions it aims to answer are: * does treatment with botulinum toxin alter gene expressions, epigenetic signatures, and cells plasticity in the masseter muscles of TMDM patients? * do any such changes differ between patients with local and regional TMDM? * does treatment with botulinum toxin influence pain characteristics (intensity, frequency, and sensibility) and other variables in patients with TMDM and are there correlations between significantly changed expression of biomarkers and other variables? Participants will be examined with a questionnaire, clinical examination (including quantitative sensory testing; QST), and microbiopsy sampling from one of the masseter (MM) and anterior tibialis (AT) muscles and are then randomized to treatment with botulinum toxin or control (isotonic saline). Follow-ups occur after one and three months for all patients, and six months with questionnaire, clinical examination, and collection of post-treatment microbiopsies to see if botulinum toxin alter peripheral molecular events and clinical variables.
Key facts
- Study ID
- NCT05720065
- Run by
- Karolinska Institutet
- People needed
- 100
- Starts
- 2023-11-14
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2026-08-05
Who can join
Age: 20 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Department of Dental Medicine, Karolinska Institutet — Huddinge, Stockholm County, Sweden (enrolling)
Full record on ClinicalTrials.gov
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