Evaluation of the Efficacy of Neuromodulation in the Control of Chronic Orofacial Pain
Enrolling by invitationNot applicableNCT07352384
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic orofacial pain significantly affects patients' quality of life, compromising essential functions such as chewing and speech. Although conventional treatments are available, many patients do not achieve adequate and lasting relief. This project investigates the effectiveness of neuromodulation techniques, namely transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS), as innovative therapeutic alternatives for the control of chronic orofacial pain. The study will be conducted in adult patients diagnosed with orofacial pain. Participants will be divided into two groups: one group will receive active neuromodulation (tDCS or TMS) and the other a sham treatment (placebo). Sessions will take place daily over two weeks. Assessments will include pain intensity, pain pressure threshold, masticatory function, and bite strength, in order to observe any functional changes. The group undergoing neuromodulation is expected to show a significant reduction in pain levels and improvements in quality of life compared to the placebo group. This study could support the adoption of neuromodulation as a complementary approach in the treatment of chronic orofacial pain, offering an effective and non-invasive alternative for patients who do not respond to conventional treatments.
Study details
- Official title
- Evaluation of the Efficacy of Neuromodulation in the Control of Chronic Orofacial Pain: A Randomized Controlled Trial
- Conditions
- Orofacial Pain
- Interventions
- Device: Active Neuromodulation (tDCS or TMS)
- Device: Sham Neuromodulation (tDCS or TMS)
- Sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Collaborators
- University of Sao Paulo; University of Aarhus; Universidade Federal de Alfenas
- Start date
- 2025-11-01
- Primary completion
- 2026-05-01
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Portugal
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age: Participants between 18 and 75 years old. * Diagnosis of Chronic Orofacial Pain: Patients with persistent orofacial pain for more than 3 months, confirmed using DC/TMD or other validated diagnostic criteria. * Pain Intensity: Baseline score on the Visual Analogue Scale (VAS) ≥ 4 (moderate to severe pain). * Treatment History: Patients who have previously tried at least one conventional treatment (e.g., medication or physiotherapy) with limited or no success. * Cognitive Ability: Participants cognitively able to understand the study procedures and provide informed consent. * Stable Medication Regimen: Stable chronic pain medication for at least four weeks prior to the intervention. Exclusion Criteria: * Neurological Disorders: History of epilepsy, seizures, or other neurological disorders that contraindicate TMS or tDCS. * Implanted Medical Devices: Presence of pacemakers, cochlear implants, or other electronic/metallic devices in the head or neck region. * Pregnancy: Pregnant or breastfeeding individuals, due to potential risks. * Psychiatric Disorders: Severe psychiatric disorders (e.g., schizophrenia, unstable major depression) that may interfere with study adherence. * Substance Abuse: Current or recent history (within the last 6 months) of alcohol or substance abuse. * Active Medical Conditions: Active infections or untreated systemic diseases that may interfere with results. * TMJ Surgery: History of recent temporomandibular joint surgery or invasive dental procedures (within the last 3 months). * Contraindications for TMS/tDCS: Sensitivity, intolerance, or inability to tolerate the neuromodulation device. * Participation in Another Study: Simultaneous or recent (within the last 3 months) participation in another clinical trial.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07352384