Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

Qualifiers

a diagnosis of TMDM myalgia or myofascial pain according to the DC/TMD criteria

females with adequate contraceptives and a negative pregnancy test

pain upon digital palpation of at least one of the masseter muscle

a characteristic pain intensity of > 40/100

Disqualifiers

difficulties understanding the Swedish language

systemic inflammatory connective tissue diseases

widespread pain

neuromuscular disorders

Trial design

Treatments tested in this trial

  • Botulinum toxin type A
  • Isotonic saline 0,9%

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators