Actively Recruiting
Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patients With Temporomandibular Disorders - A Quality Study Associated With a New Treatment Routine
Led by Region Stockholm · Updated on 2025-04-24
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Botulinum toxin A (BTX) as a treatment for patients with myogenous temporomandibular disorders (TMD), a condition causing muscle-related jaw pain. The study aims to find out if BTX injections in the masseter and temporalis muscles reduce pain and improve quality of life, and if the effect depends on the dose given. It also explores whether different sub-groups of myogenous TMD respond differently to treatment. Participants will receive one of two doses of BTX: either 50 units or 100 units, both dissolved in sterile saline and injected into the targeted jaw muscles. This is a randomized study with two groups receiving different doses to compare effects. The treatments are given according to a defined protocol to assess pain relief and other outcomes over time. During the study, participants will be monitored for changes in pain levels, quality of life using the Oral Health Impact Profile questionnaire, jaw opening ability, pressure pain threshold, and psychological factors. These assessments will be conducted over a six-month period to understand the treatment effects. Safety and impact of the doses on pain relief will be closely observed throughout the trial.
CONDITIONS
Brief Title
Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has given written consent
- Diagnosed with myalgia, myofacial pain, or myofascial pain with referred pain
- Average pain score of 3 or higher on the NRS scale for more than three months
- Palpation pain in masseter or temporalis muscles
- No treatment for orofacial pain within the last three months
- Using adequate contraceptives and has a negative pregnancy test
- May have co-diagnoses such as disc displacement with or without reduction, degenerative joint disease, or arthralgia
You will not qualify if you...
- Received Botulinum toxin treatment in the last 12 months
- Treatment for orofacial pain within the last 3 months
- Has systemic inflammatory diseases like rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
- Has widespread pain conditions such as fibromyalgia
- Neuropathic pain or neurologic diseases like myasthenia gravis
- Pain caused by dental issues
- Currently using muscle relaxants or aminoglycoside antibiotics
- Pregnant or nursing
- Hypersensitivity to Botulinum toxin
- Has neuropsychiatric conditions
- Difficulty understanding the Swedish language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment with effects observed up to 6 months
Participants receive injections of Botulinum toxin A into the masseter and temporalis muscles to reduce pain associated with myogenous temporomandibular disorders.
1 treatment visit and follow-up assessments over 6 months
Trial Site Locations
Total: 1 location
1
Eastman institute Folktandvården Region Stockholm
Stockholm, Sweden, 11324
Actively Recruiting
Research Team
V
Veronica de Flon
H
Hajer Jasim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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