RecruitingPhase 3NCT06941636

Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders

Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders - a Quality Study Associated to a New Treatment Routine

Sponsor

Region Stockholm

Enrollment

90 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Temporomandibular Disorder

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria10

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 Criteria12

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

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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.