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New treatment option for Myofascial Pain Syndrome (MPS)
Official title EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles
ClinicalTrials.gov ID: NCT07082972
What this study is testing
What is Botulinum toxin injection?
Botulinum toxin injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for myofascial pain syndrome (mps).
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
- This randomized controlled clinical trial aims to evaluate the individual and combined effects of occlusal splint therapy and botulinum toxin type A (BTX-A) injections into the masseter muscle on the activity of head and neck muscles in patients diagnosed with myofascial pain syndrome (MPS). MPS is a common subtype of temporomandibular disorders (TMD), frequently involving the masticatory and cervical muscles.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
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 55
You may be able to join if
- Having a diagnosis of myofascial pain syndrome
- No missing teeth
- No history of previous temporomandibular disorder treatment
- Absence of an arthrogenic temporomandibular disorder
You likely can't join if
- Pregnancy or lactation; osteoporosis and bisphosphonate use
- Previous botulinum toxin injection to the masseter region
- Bleeding disorders or use of anticoagulant medications
- Presence of systemic muscular or neurological diseases (e.g., myasthenia gravis, ALS)
- Active infection, open wound, or dermatological condition in the facial area
- Undergoing other facial aesthetic procedures (e.g., fillers, PRP, etc.) within the last six months
See the full eligibility criteria
- Having a diagnosis of myofascial pain syndrome
- No missing teeth
- No history of previous temporomandibular disorder treatment
- Absence of an arthrogenic temporomandibular disorder
- Pregnancy or lactation; osteoporosis and bisphosphonate use
- Previous botulinum toxin injection to the masseter region
- Bleeding disorders or use of anticoagulant medications
- Presence of systemic muscular or neurological diseases (e.g., myasthenia gravis, ALS)
- Active infection, open wound, or dermatological condition in the facial area
- Undergoing other facial aesthetic procedures (e.g., fillers, PRP, etc.) within the last six months
- Individuals with severe psychiatric disorders or those on regular psychiatric medications
- Patients who are unlikely to comply with the study protocol or complete the follow-up period
- Individuals with a body mass index (BMI) outside the normal range, including underweight or overweight participants, will be excluded from the study.
The study team makes the final eligibility decision.
Where it's taking place
- Istanbul, Vezneciler, Turkey (Türkiye)
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 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Istanbul, Vezneciler, Turkey (Türkiye). 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.