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NCT Number: NCT06941636

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Eastman institute Folktandvården Region Stockholm

Stockholm, 11324, Sweden

Location status: Recruiting

Location contact

Veronica de Flon

CONTACT

[email protected]

+46702182623

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5U/0,1 ml Botulinum toxin A

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.

Other names: Botox®100 U, AbbVie

10U/0,1 ml Botulinum toxin A

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.

Other names: Botox®100 U, AbbVie

Primary outcomes

  1. Changes in pain and impact of doses on pain relief

    Time frame: Six months

    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)

Secondary outcomes

  1. Changes in quality of life according to The Oral Healthy Impact profile questionnaire (OHIP-5)

    Time frame: 6 months

    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

  2. Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes.

    Time frame: 6 months

    Treatment outcome in sub-groups of myogenous TMD.

  3. Changes i pressure pain threshold (PPT)

    Time frame: 6 months

    Sensitivity to pressure induced pain by PPT (pressure pain threshold). PPT will be measured three times and average value will be used.

  4. Changes in psychological factors

    Time frame: 6 months

    According to changes in Axis II (a psykometric form)

Study contacts

Contact information is provided by the study sponsor or research team.

Hajer Jasim

CONTACT

[email protected]

Veronica de Flon

CONTACT

[email protected]

+ 46 702182623

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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