Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
- Conditions
- Temporomandibular Disorder
- Interventions
- Drug: 5U/0,1 ml Botulinum toxin ADrug: 10U/0,1 ml Botulinum toxin A
- Registration Number
- NCT06941636
- Lead Sponsor
- Region Stockholm
- Brief Summary
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.
- Detailed Description
The primary goal with this study is to expand treatment modalities for patient with myogenous TMD, and to develop clinical protocols with adequate doses for myogenous TMD. A secondary goal is to study if there are differences in treatment effect between sub-groups of myogenous TMD for more personalised pain-treatment.
Hypothesis The investigators hypothesis is that application of BTX into the masseter and temporalis muscle will reduce pain and increase quality of life in patients with myogenous TMD, and that the reduction of pain is only to a certain degree due to the dose. High doses of BTX does not necessarily entail increased reduction of pain or better quality of life. The investigators also hypotheses that the effect may differ in sub-groups of myogenous TMD.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BTX-L for myogenous TMD 5U/0,1 ml Botulinum toxin A Patients (n=45) with myogenious TMD will receive treatment with 50 U of Botox®100 U, AbbVie. The drug will be dissolved in 2 millilitres of room-temperate sterile isotonic saline. This gives 5U/0,1 ml solution and each patient will receive a total o 50 U as described in the protocol BTX-H for myogenous TMD 10U/0,1 ml Botulinum toxin A Patients (n=45) with myogenious TMD will receive treatment with 100 U of Botox®100 U, AbbVie. The drug will be dissolved in 1 millilitre of room-temperate sterile isotonic saline. This gives 10U/0,1 ml solution and each patient will receive a total of 100 U as described in the protocol
- Primary Outcome Measures
Name Time Method Changes in pain and impact of doses on pain relief Six months Pain level will be assessed using the Numeric rating Scale (NRS, a scale ranging from 0 (no pain) to 10 (worst pain imaginable). A 30% reduction in pain according to the NRS is considered a significant effect. The study compare two doses (low and high)
- Secondary Outcome Measures
Name Time Method Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes. 6 months Treatment outcome in sub-groups of myogenous TMD.
Changes i pressure pain threshold (PPT) 6 months Sensitivity to pressure induced pain by PPT (pressure pain threshold). PPT will be measured three times and average value will be used.
Changes in psychological factors 6 months According to changes in Axis II (a psykometric form)
Changes in quality of life according to The Oral Healthy Impact profile questionnaire (OHIP-5) 6 months The influence of the quality of life will be measured. Scores are categorized as follow: No influence (0-7 p), some influence (8-15 p) and large influence (16-20 p). Higher score mean worse outcomes
Trial Locations
- Locations (1)
Eastman institute Folktandvården Region Stockholm
🇸🇪Stockholm, Sweden