Temporomandibular Disorder
Conditions
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.
Interventions
DRUG5U/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.
DRUG10U/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.
Sponsors
Region Stockholm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Masking description
The preparation of the drugs and syringe is made by a research assistant.Preparation is performed immediately before the injection. The research assistant will hand over the syringe with the drug to be injected to the investigator to ensure that the patient and the investigator are blinded.
Intervention model description
A randomized doubleblind single-center clinical trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
Sweden
Contacts
Primary ContactVeronica de Flon
Backup ContactHajer Jasim
Outcome results
None listed