Health Condition 1: G891- Acute pain, not elsewhere classified
Conditions
Interventions
Intervention1: wearable device for controlling neuropathic pain: Patients reporting at the OPD with TN (ICHD-3) criteria, shall be included and assessed for the effect of the vibrotactile device in r
Sponsors
Dr Samapika Routray
Eligibility
Inclusion criteria
Inclusion criteria: Adults more than 18 years. Clinically confirmed classical Trigeminal Neuralgia (TN) according to International Classification of Headache Disorders (ICHD-3) criteria. At least 3 paroxysmal episodes of pain per day, reported over the last 2 weeks. TN symptoms have been present for at least 6 months. The average VAS pain score has been 4 out of 10 over the past week. Willingness and ability to provide informed written consent and comply with the study protocol. No other known causes of neuropathy
Exclusion criteria
Exclusion criteria: a. Secondary TN due to tumors, multiple sclerosis, vascular compression other than idiopathic classical TN, or post-herpetic neuralgia. b. History of facial surgery, trauma, or skin condition (e.g., dermatitis, open wounds) in the stimulation area. c. Recent invasive procedure (e.g., microvascular decompression, radiofrequency ablation) in the past 6 months. d. Implanted neurostimulator or pacemaker e. Uncontrolled psychiatric conditions, such as severe depression, anxiety, or psychosis. f. Pregnant or breastfeeding women. g. Substance abuse or dependency in the past year. h. Neurological or systemic condition interfering with pain perception or response (e.g., diabetic neuropathy, epilepsy). i. Participation in another clinical trial involving an investigational device or drug within the past 3 months. j. Other neurological and psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the effect of a vibrotactile device in reducing the acute pain of trigeminal neuralgia using a visual analogue scale 2.To assess the effect of a vibrotactile device on improving the quality of life in trigeminal neuralgia patients Timepoint: 6 consecutive sessions | — |
Secondary
| Measure | Time frame |
|---|---|
| determine which frequency of stimulation is most suited for reducing trigeminal neuralgic painTimepoint: 6 consecutive time points | — |
Countries
India
Contacts
Public ContactDr Samapika Routray
All india Institute of Medical Sciences
Outcome results
None listed