Actively Recruiting

Phase 2
Age: 20Years - 45Years
FEMALE
NCT05720065

Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A

Led by Karolinska Institutet · Updated on 2025-02-17

50

Participants Needed

1

Research Sites

205 weeks

Total Duration

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AI-Summary

What this Trial Is About

The goal of this clinical trial is to investigate the effect of botulinum toxin on neurons' plasticity in the masseter muscle in humans with and without painful myogenous temporomandibular disorders (TMDM). The main questions it aims to answer are: * does treatment with botulinum toxin alter gene expressions, epigenetic signatures, and cells plasticity in the masseter muscles of TMDM patients? * do any such changes differ between patients with local and regional TMDM? * does treatment with botulinum toxin influence pain characteristics (intensity, frequency, and sensibility) and other variables in patients with TMDM and are there correlations between significantly changed expression of biomarkers and other variables? Participants will be examined with a questionnaire, clinical examination (including quantitative sensory testing; QST), and microbiopsy sampling from one of the masseter (MM) and anterior tibialis (AT) muscles and are then randomized to treatment with botulinum toxin or control (isotonic saline). Follow-ups occur after one and three months for all patients, and six months with questionnaire, clinical examination, and collection of post-treatment microbiopsies to see if botulinum toxin alter peripheral molecular events and clinical variables.

CONDITIONS

Official Title

Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A

Who Can Participate

Age: 20Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of myalgia or myofascial pain related to temporomandibular disorders using DC/TMD criteria
  • Female participants using adequate contraception and with a negative pregnancy test
  • Pain present when pressing on at least one masseter muscle
  • Characteristic pain intensity greater than 40 on a 100-point scale
  • Negative pregnancy test on the day of treatment
Not Eligible

You will not qualify if you...

  • Difficulty understanding the Swedish language
  • Systemic inflammatory connective tissue diseases
  • Widespread pain
  • Neuromuscular disorders
  • Diagnosed or severe psychiatric illness
  • Neuropathic pain
  • Pain originating from dental issues
  • History of trauma to the face, head, or neck
  • Pregnancy or breastfeeding
  • Known allergy to botulinum toxin or antibiotics
  • Use of muscle relaxants, antidepressants, neuropsychiatric, anticoagulant drugs, or aminoglycoside antibiotics
  • Previous botulinum toxin treatment within the last 12 months
  • Use of pain relief or anti-inflammatory medication within 48 hours before biopsy
  • Skin infection over the injection or biopsy site

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

Department of Dental Medicine, Karolinska Institutet

Huddinge, Stockholm County, Sweden, SE14104

Actively Recruiting

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Research Team

M

Malin Ernberg, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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