Burning mouth syndrome
Conditions
Interventions
Active stimulation group:Anode placed over the left DLPFC, cathode over the right frontal pole. Stimulation parameters: 2 mA, 20 minutes per session, twice daily (=2?hour interval), 2–3 days per week
Sham stimulation group:A "short onset + current decay" protocol was applied as the placebo control
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. International Classification of Headaches, Third Edition (ICHD-3) BMS diagnostic criteria: (1) Oral pain lasting more than 2 hours per day for more than 3 months; (2) Characterised by burning pain confined to the superficial oral mucosa; (3) May be accompanied by tongue numbness, dry mouth, dysgeusia, or other uncomfortable symptoms; (4) The burning sensation persists or increases in intensity during the day and does not interfere with eating, drinking, or sleeping; (5) The appearance of the oral mucosa is normal, and the clinical examination of the oral mucosa, including sensory examination, is normal; (6) No local or systemic causes of burning pain in the oral mucosa, such as oral mucositis, oral candidiasis, glossitis, Sjogren’s syndrome, diabetes, anemia, and cardiovascular disease, have been found. 2. BMS Subjects Inclusion Criteria: (1) Meets BMS diagnostic criteria; (2) Age >= 18 and = 3 months; (4) Visual Analogue Score (VAS) > 3 points; (5) Understands, agrees to participate in this study and signs the informed consent form, and cooperates with the treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Presence of detectable organic lesions with pain in the oral mucosa, teeth or periodontal tissues, such as ulcers, deep caries, periodontitis, etc. 2. History of orofacial neuralgia, such as trigeminal neuralgia, glossopharyngeal neuralgia, diabetic neuropathy, chemotherapy-induced neuropathy 3. History of head and neck radiotherapy accompanied by salivary gland diseases or other oral mucosal diseases 4. Diabetes, autoimmune diseases, or severe diseases of vital organs including the heart, liver, kidneys and hematological system 5. Primary psychiatric disorders (including major depressive disorder, severe personality disorders) or history of substance abuse (excluding caffeine and nicotine) 6. Comorbidity with other chronic pain-related disorders, such as fibromyalgia, chronic headache, postherpetic neuralgia 7. Comorbidity with other vitamin B12 deficiency-related diseases, such as pernicious anemia 8. Received treatment with central nervous system-related medications (e.g., anxiolytics, antidepressants, GABAergic drugs) within the past 1 month 9. Received treatments potentially affecting the central nervous system (e.g., transcranial magnetic stimulation, electrical stimulation) within the past 6 months 10. Contraindications to transcranial direct current stimulation (tDCS): recent traumatic brain injury, history of seizures, brain surgery, intracranial hypertension, pacemaker or other metallic implants, abnormal response to electrical stimulation, etc. 11. Contraindications to MRI: metallic cardiac pacemaker, implantable defibrillator, intracranial metallic implants, claustrophobia 12. Severe cognitive impairment or inability to cooperate with assessment and treatment 13. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of oral mucosal pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| The sensory and affective aspects of pain;The state of central sensitization;Symptoms of generalized anxiety;Depressive symptoms;The oral health-related quality of life;Sleep quality;gray matter volume (GMV), cortical thickness (CT), etc.;Resting-State Brain Function;Unstimulated salivary flow rate;Salivary molecules;Clinical Global Impression;Patient Global Impression; | — |
Countries
China
Contacts
Public ContactDu Guanhuan
Department of Oral Medicine, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School
Outcome results
None listed