Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06813040

Efficacy of Repetitive Transcranial Magnetic Stimulation in Chronic Pain in Patients with Temporomandibular Disorders

Led by University of Coimbra · Updated on 2025-02-13

40

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Temporomandibular disorder (TMD) includes musculoskeletal conditions affecting the jaw joint, chewing muscles, and nearby structures. About 30 to 40% of acute painful TMD cases become chronic, causing ongoing pain that affects daily life, emotional well-being, and quality of life. Chronic orofacial pain involves complex biological and psychological factors, making treatment challenging. This trial investigates the effectiveness of transcranial magnetic stimulation (TMS), a non-invasive brain stimulation method, in treating chronic TMD pain and aims to identify predictors of treatment success using brain connectivity and psychosocial assessments. Participants receive either active or sham repetitive transcranial magnetic stimulation (rTMS) over the motor cortex. The active rTMS is applied at 10Hz with 2000 pulses per session at 90% of the resting motor threshold, using a figure-8 coil. Ten sessions are conducted, spaced between 24 to 72 hours apart. The sham treatment mimics the look and sound of rTMS without delivering magnetic pulses. This randomized, triple-blinded trial compares these two groups to assess rTMS effects on chronic TMD. Participants will be assessed for pain intensity and jaw function before and after all rTMS sessions, with follow-ups at one week, two weeks, and one month post-treatment. Additional evaluations include pain-related disability, depression, anxiety, central sensitization, quality of life, and brain functional connectivity at various time points during and after treatment. The study tracks changes across these measures to understand the impact and safety of rTMS in chronic TMD over the course of treatment and follow-up periods.

CONDITIONS

Brief Title

Efficacy of Repetitive Transcranial Magnetic Stimulation in Temporomandibular Disorders.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals of both sexes, literate, aged over 18 years with a diagnosis of muscular and/or joint TMD by the Diagnostic Criteria for Temporomandibular Disorders (DC-TMD)
  • Orofacial pain lasting longer than 6 months
  • Orofacial pain intensity greater than 5 on the visual analogue scale (VAS)
Not Eligible

You will not qualify if you...

  • Verbal communication impairment due to neurological disorder, previous illness sequelae, or psychiatric condition
  • Pregnant women
  • Presence of any impediment to MRI such as pacemaker, cochlear implant, ferromagnetic clips, deep brain stimulation electrodes, ocular implants, Swan-Ganz catheter, orthopedic prostheses, or metal near the area of interest
  • Contraindications for transcranial magnetic stimulation including focal or generalized encephalopathies, increased intracranial pressure, severe heart disease, history of head trauma or epilepsy, family history of idiopathic epilepsy, use of drugs lowering seizure threshold, chronic alcohol or epileptogenic drug use

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Implementation

Duration - 10 sessions with a minimum interval of 24 hours and a maximum of 72 hours between sessions

Participants receive repetitive transcranial magnetic stimulation (rTMS) over the motor cortex with either active or sham device sessions.

10 visits (in-person) for device sessions

Follow-up

Duration - 1 month after treatment completion

Participants are monitored for changes in pain intensity, functional limitation, and other secondary outcomes after treatment.

3 visits at 1 week, 2 weeks, and 1 month after treatment

Trial Site Locations

Total: 1 location

1

University of Coimbra

Coimbra, Portugal, 3000-548

Actively Recruiting

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Research Team

M

Miguel Castelo-Branco

C

Catarina Duarte

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†.

Eric Schiffman, Richard Ohrbach, Edmond Truelove...

https://pubmed.ncbi.nlm.nih.gov/24482784

Longitudinal outcome of temporomandibular disorders: a 5-year epidemiologic study of muscle disorders defined by research diagnostic criteria for temporomandibular disorders.

Peter Rammelsberg, Linda LeResche, Samuel Dworkin...

https://pubmed.ncbi.nlm.nih.gov/12756926

The neuro-pathophysiology of temporomandibular disorders-related pain: a systematic review of structural and functional MRI studies.

Yuanyuan Yin, Shushu He, Jingchen Xu...

https://pubmed.ncbi.nlm.nih.gov/32560622

The efficacy of transcranial direct current stimulation and transcranial magnetic stimulation for chronic orofacial pain: A systematic review.

Natália R Ferreira, Ygor N Junqueira, Nathália B Corrêa...

https://pubmed.ncbi.nlm.nih.gov/31415654