Using Botulinumtoxin A to treat pain in jaw disorders
Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders - a Quality Study Associated to a New Treatment Routine
This study is testing if Botulinumtoxin A injections can help reduce pain and improve life for people with jaw disorders caused by muscle issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06941636 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Botulinumtoxin A (BTX) injections in the masseter and temporal muscles for patients suffering from myogenous temporomandibular disorders (TMD). The primary goal is to determine if BTX can reduce pain and improve quality of life, while also exploring whether the effects are dose-dependent. Additionally, the study aims to identify differences in treatment outcomes among various sub-groups of myogenous TMD to personalize pain management strategies.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with myalgia or myofascial pain related to temporomandibular disorders, experiencing moderate to severe pain for over three months.
Not a fit: Patients with systemic inflammatory diseases, widespread pain conditions, or those who have received recent treatments for orofacial pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain and enhance the quality of life for patients with myogenous TMD.
How similar studies have performed: Previous studies have shown promising results with BTX for pain management in similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm
- Eastman institute Folktandvården Region Stockholm — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Veronica de Flon — Region Stockholm
- Study coordinator: Veronica de Flon
- Email: veronica.deflon@regionstockholm.se
- Phone: + 46 702182623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.