Clinical trial NCT06941636: Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Temporomandibular Disorder
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2025-04-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized doubleblind single-center clinical trial.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Changes in pain and impact of doses on pain relief
timeFrame: Six months
Secondary outcomes:
measure: Changes in quality of life according to The Oral Healthy Impact profile questionnaire (OHIP-5)
timeFrame: 6 months
measure: Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes.
timeFrame: 6 months
measure: Changes i pressure pain threshold (PPT)
timeFrame: 6 months
measure: Changes in psychological factors
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Eastman institute Folktandvården Region Stockholm
Study officials:
affiliation: Region Stockholm
name: Veronica de Flon
role: PRINCIPAL_INVESTIGATOR
References: