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New treatment option for Temporomandibular Disorder
Official title Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
ClinicalTrials.gov ID: NCT06941636
What this study is testing
What is 5U/0,1 ml Botulinum toxin A?
5U/0,1 ml Botulinum toxin A is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for temporomandibular disorder.
Also referred to as Botox®100 U, AbbVie.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
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 female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.