Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 5U/0,1 ml Botulinum toxin A, 10U/0,1 ml Botulinum toxin A.
- Who it may be relevant to
- Registry conditions: Temporomandibular Disorder. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders - a Quality Study Associated to a New Treatment Routine
Overview
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.
Interventions
- Drug 5U/0,1 ml Botulinum toxin A
Botox® 100 U (AbbVie) will be dissolved in 2 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 5 U/0.1 mL. Each patient will receive a total dose of 50 U, administered bilaterally into the masseter and temporalis muscles. - Drug 10U/0,1 ml Botulinum toxin A
Botox® 100 U (AbbVie) will be dissolved in 1 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 10 U/0.1 mL. Each patient will receive a total dose of 100 U, administered bilaterally into the masseter and temporalis muscles.
Primary outcome measures
- Changes in pain and impact of doses on pain relief [Time frame: Six months]
Secondary outcome measures (4)
- Changes in quality of life according to The Oral Healthy Impact profile questionnaire (OHIP-5) [Time frame: 6 months]
- Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes. [Time frame: 6 months]
- Changes i pressure pain threshold (PPT) [Time frame: 6 months]
- Changes in psychological factors [Time frame: 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Sweden · 1 center
- Eastman institute Folktandvården Region Stockholm — Stockholm
Identifiers
NCT: NCT06941636 · 2023-504033-44-00