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Effects by botulinum toxin in patients with jaw muscle pain
EU CTIS ID: 2024-514739-12-00
What this study is testing
To investigate if treatment with BTX alter gene expressions, epigenetic signatures, and cells plasticity in the masseter muscle of patients with TMDM
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A diagnosis of myalgia or myofascial pain with referral according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) axix I
- Female aged 20 – 45 years
- A characteristic pain intensity of > 40/100
- Pain upon digital palpation of at least one of the masseter muscles
- Males aged 20 – 45 years
You likely can't join if
- Difficulties understanding the Swedish language
- Known allergy to botulinum toxin or antibiotics
- Use of muscle relaxants, antidepressant, neuropsychiatric, or anticoagulant drugs
- Use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy
- Previous treatment with BTX during the last 12 months
- Infection at the injection site
See the full eligibility criteria
- A diagnosis of myalgia or myofascial pain with referral according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) axix I
- Female aged 20 – 45 years
- A characteristic pain intensity of > 40/100
- Pain upon digital palpation of at least one of the masseter muscles
- Males aged 20 – 45 years
- Difficulties understanding the Swedish language
- Known allergy to botulinum toxin or antibiotics
- Use of muscle relaxants, antidepressant, neuropsychiatric, or anticoagulant drugs
- Use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy
- Previous treatment with BTX during the last 12 months
- Infection at the injection site
- Systemic inflammatory connective tissue diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) c) widespread pain (e.g. fibromyalgia)
- Widespread pain (e.g. fibromyalgia)
- Neuromuscular disorders (e.g. craniomandibular dystonia, myasthenia gravis)
- Diagnosed or severe psychiatric disease (e.g. schizophrenia, bipolar disorder)
- Neuropathic pain
- Pain of dental origin
- History of trauma to the face, head or neck (incl. orthognathic surgery)
- Pregnancy or nursing
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.