Actively Recruiting

Phase 3
Age: 18Years - 50Years
FEMALE
NCT06941636

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

Led by Region Stockholm · Updated on 2025-04-24

90

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written consent given
  • Diagnosis of myalgia, myofacial pain, or myofascial pain with referred pain
  • Average pain score of 3 or higher for more than three months
  • Palpation pain in masseter or temporalis muscles
  • No orofacial pain treatment within the past three months
  • Use of adequate contraceptives and negative pregnancy test
  • Presence of co-diagnoses such as disc displacement with or without reduction, degenerative joint disease, or arthralgia allowed
Not Eligible

You will not qualify if you...

  • Botulinum toxin treatment within the last 12 months
  • Orofacial pain treatment within the last 3 months
  • Systemic inflammatory diseases like rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
  • Widespread pain conditions such as fibromyalgia
  • Neuropathic pain
  • Neurologic diseases like myasthenia gravis
  • Pain caused by dental issues
  • Use of muscle relaxants or aminoglycoside antibiotics
  • Pregnancy or nursing
  • Hypersensitivity to Botulinum toxin
  • Neuropsychiatric conditions
  • Difficulty understanding the Swedish language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Eastman institute Folktandvården Region Stockholm

Stockholm, Sweden, 11324

Actively Recruiting

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Research Team

V

Veronica de Flon

CONTACT

H

Hajer Jasim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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