Investigating the effects of botulinum toxin on jaw pain mechanisms
Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A. A Randomized, Controlled, Double-blind Study
This study is testing if botulinum toxin can help reduce jaw pain by looking at how it affects the muscles and nerves in people with and without jaw disorders.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge, Stockholm County) |
| Trial ID | NCT05720065 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore how botulinum toxin affects neuronal plasticity in the masseter muscle of individuals with and without painful temporomandibular disorders (TMDM). Participants will undergo a thorough assessment, including questionnaires, clinical examinations, and biopsies, before being randomly assigned to receive either botulinum toxin or a saline placebo. The study will evaluate changes in gene expression, pain characteristics, and other relevant biomarkers to determine the treatment's efficacy. The trial is conducted at the University Dental Clinic, Karolinska Institutet in Sweden.
Who should consider this trial
Good fit: Ideal candidates are females diagnosed with myalgia or myofascial pain related to TMDM, experiencing significant pain upon palpation of the masseter muscle.
Not a fit: Patients with systemic inflammatory diseases, widespread pain, or those who have recently received botulinum toxin treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief from pain and improve quality of life for patients suffering from temporomandibular disorders.
How similar studies have performed: Previous studies have shown promising results with botulinum toxin for treating various pain conditions, suggesting potential success for this approach in TMDM.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Huddinge, Stockholm County
- Department of Dental Medicine, Karolinska Institutet — Huddinge, Stockholm County, Sweden (Recruiting)
Study contacts
- Principal investigator: Malin Ernberg — Karolinska Institutet
- Study coordinator: Malin Ernberg, PhD
- Email: malin.ernberg@ki.se
- Phone: +46706368236
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.