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

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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Drug: 5U/0,1 ml Botulinum toxin A; Drug: 10U/0,1 ml Botulinum toxin A

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Veronica de Flon; Phone Number: + 46 702182623; Email: veronica.deflon@regionstockholm.se
• Study Contact Backup: Name: Hajer Jasim; Email: hajer.jasim@reigionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden, 11324
    • Recruiting
    • Eastman institute Folktandvården Region Stockholm
    • Contact: Veronica de Flon; Phone Number: +46702182623; Email: veronica.deflon@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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.; Other Names: Botox®100 U, AbbVie
Active Comparator: 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	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.; Other Names: Botox®100 U, AbbVie

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pain and impact of doses on pain relief	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)	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life according to The Oral Healthy Impact profile questionnaire (OHIP-5)	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	6 months
Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes.	Treatment outcome in sub-groups of myogenous TMD.	6 months
Changes i pressure pain threshold (PPT)	Sensitivity to pressure induced pain by PPT (pressure pain threshold). PPT will be measured three times and average value will be used.	6 months
Changes in psychological factors	According to changes in Axis II (a psykometric form)	6 months

Collaborators and Investigators

• Sponsor: Region Stockholm
• Investigators: Principal Investigator: Veronica de Flon, Region Stockholm

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Stomatognathic Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Musculoskeletal Pain; Craniomandibular Disorders; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Myalgia; Facial Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA; Botulinum Toxins
• Other Study ID Numbers: 2023-504033-44-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No