Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulard… (NCT06941636) | Clinical Trial Compass
RecruitingPhase 3
Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
Sweden90 participantsStarted 2025-05-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
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:
* 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 Criteria:
* 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
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
Changes in pain and impact of doses on pain relief