Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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, and biopsy sampling from one of the masseter and are then randomized to treatment with botulinum toxin or control (isotonic saline). Follow-ups occur after one, three, 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• difficulties understanding the Swedish language

• systemic inflammatory connective tissue diseases

• widespread pain

• neuromuscular disorders

• diagnosed or severe psychiatric disease

• neuropathic pain

• pain of dental origin

• history of trauma to the face, head or neck

• pregnancy or nursing

• known allergy to botulinum toxin or antibiotics

• use of muscle relaxants, antidepressant, neuropsychiatric, anticoagulant drugs, or aminoglycoside antibiotics

• previous treatment with botulinum toxin during the last 12 months

• use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy

• skin infection over injection/biopsy site