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

Region Stockholm

Status and phase: Enrolling; Phase 3

Conditions: Temporomandibular Disorder

Treatments: Drug: 5U/0,1 ml Botulinum toxin A; Drug: 10U/0,1 ml Botulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT06941636

2023-504033-44-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

BTX-L for myogenous TMD

Active Comparator group

Description:

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

Treatment:

Drug: 5U/0,1 ml Botulinum toxin A

BTX-H for myogenous TMD

Active Comparator group

Description:

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

Treatment:

Drug: 10U/0,1 ml Botulinum toxin A