Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A (NCT05720065) | Clinical Trial Compass
RecruitingPhase 2
Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A
Sweden100 participantsStarted 2023-11-14
Plain-language summary
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.
Who can participate
Age range
20 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of gene expression measured with bulk RNA-seq
Timeframe: 1-6 months
2
Change of RNA expression measured with single-cell RNA (scRNA) seq/spatial trnascriptomics.
Timeframe: 1-6 months
3
Change of expression of sensory neuron markers measured with IHC
Timeframe: 1-6 months
4
Change of proteome measured with proteomics
Timeframe: 1-6 months
5
Change of proteome measured with affinity-based proteomics.