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

NCT ID: NCT06941636

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-12-01

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.

Conditions

Temporomandibular Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

BTX-L for myogenous TMD

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

Group Type: ACTIVE_COMPARATOR

5U/0,1 ml Botulinum toxin A

Intervention Type: DRUG

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.

BTX-H for myogenous TMD

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

Group Type: ACTIVE_COMPARATOR

10U/0,1 ml Botulinum toxin A

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Botox®100 U, AbbVie; Botox®100 U, AbbVie

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronica de Flon

Role: PRINCIPAL_INVESTIGATOR

Region Stockholm

Locations

Eastman institute Folktandvården Region Stockholm

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Veronica de Flon

Role: CONTACT

veronica.deflon@regionstockholm.se

+ 46 702182623

Hajer Jasim

Role: CONTACT

hajer.jasim@reigionstockholm.se

Facility Contacts

Veronica de Flon

Role: primary

veronica.deflon@regionstockholm.se

+46702182623

Other Identifiers

2023-504033-44-00

Identifier Type: -

Identifier Source: org_study_id