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CTRI Number  CTRI/2026/02/103083 [Registered on: 05/02/2026] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Validation of a wearable device for controlling pain in Trigeminal Neuralgia 
Scientific Title of Study   Validation of a wearable device for controlling neuropathic pain in Trigeminal Neuralgia patients: A RCT 
Trial Acronym  CRAWLER 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Samapika Routray 
Designation  Additional Professor 
Affiliation  All india Institute of Medical Sciences 
Address  Department of Dentistry All India Institute of Medical Sciences Bhubaneswar, Odisha-751019
Sijhua,Dumduma
Khordha
ORISSA
751019
India 
Phone  9937149690  
Fax    
Email  dent_samapika@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samapika Routray 
Designation  Additional Professor 
Affiliation  All india Institute of Medical Sciences 
Address  Department of Dentistry All India Institute of Medical Sciences Bhubaneswar, Odisha-751019
Sijhua,Dumduma
Khordha
ORISSA
751019
India 
Phone  9937149690  
Fax    
Email  dent_samapika@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Samapika Routray 
Designation  Additional Professor 
Affiliation  All india Institute of Medical Sciences 
Address  Department of Dentistry All India Institute of Medical Sciences Bhubaneswar, Odisha-751019
Sijhua,Dumduma
Khordha
ORISSA
751019
India 
Phone  9937149690  
Fax    
Email  dent_samapika@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Samapika Routray 
Address  Additional Professor Department of Dentistry All India Institute of Medical Sciences Bhubaneswar, Odisha-751019  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Samapika Routray  Additional Professor Department of Dentistry All India Institute of Medical Sciences   Sijhua,Dumduma,Bhubaneswar, Odisha-751019
Khordha
ORISSA 
9937149690

dent_samapika@aiimsbhubaneswar.edu.in 
Dr Samapika Routray  All India Institute of Medical Sciences  Sijhua Dumduma
Khordha
ORISSA 
9937149690

dent_samapika@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC(AIIMS,Bhubaneswar)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G891||Acute pain, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo intervention for Patients diagnosed with TN   Patients reporting at the OPD WITH clinically confirmed classical Trigeminal Neuralgia (TN) according to International Classification of Headache Disorders (ICHD-3) criteria, shall be included and assessed for the effect of the placebo device in reducing acute pain of trigeminal neuralgia using a visual analogue scale. Their consent shall be taken, and then the patient shall be included in the study. A randomised sampling technique shall be followed. A demo shall be given related to the use of the device with vibrators, their placement, frequency adjustment and then after a session, a visual analogue scale shall be recorded for each patient. The recordings shall be done for 6 consecutive sessions for each patient to see the effectiveness.The ACPA’s Quality of Life Scale is a single item measure of function for people with chronic pain. Quality of Life is rated using an 11-point scale ranging from “Non-Functioning” to “Normal Quality of Life”. The ACPA Quality of Life scale was developed specifically as a measure of functioning for people with chronic pain. 
Intervention  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 reducing acute pain of trigeminal neuralgia using a visual analogue scale. A randomised sampling technique shall be followed. A demo shall be given related to the use of the device with vibrators, their placement, frequency adjustment and then after a session, a visual analogue scale shall be recorded for each patient. The recordings shall be done for 6 consecutive sessions for each patient to see the effectiveness.The ACPA’s Quality of Life Scale is a single item measure of function for people with chronic pain. Quality of Life is rated using an 11-point scale ranging from “Non-Functioning” to “Normal Quality of Life”. The ACPA Quality of Life scale was developed specifically as a measure of functioning for people with chronic pain. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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
 
6 consecutive sessions  
 
Secondary Outcome  
Outcome  TimePoints 
determine which frequency of stimulation is most suited for reducing trigeminal neuralgic pain  6 consecutive time points 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Trigeminal Neuralgia(TN) is a relatively rare and crippling facial pain disorder. TN has an incidence of 4–5 cases per 100,000 of the population. It is nearly twice as common in women, and the incidence increases with age to around 1 in 1000 patients older than 75 years.[1] Carbamazepine is the only medication approved by the FDA for treating trigeminal neuralgia. It has level A (effective) evidence per a 2008 American Academy of Neurology (AAN) practice parameter and systematic review.[2] Surgery is often considered when pharmacologic therapies fail and more aggressive treatment is pursued. The 2008 AAN Systematic Review concluded that Gasserian ganglion percutaneous techniques (rhizotomy), gamma knife radiosurgery, and microvascular decompression “may be considered” (Level C recommendation).[3] Neuromodulation has been studied in recent times to counter this kind of neuropathic pain. Currently, devices vary in invasiveness, ranging from SPG blocks to transcranial magnetic stimulation, transcutaneous electric nerve stimulation, peripheral nerve stimulation, direct stimulation, deep brain stimulation, and acoustic stimulation.[4,5] Utilising the gate control theory of pain modulation, we have developed a device using vibrotactile stimulation to inhibit the pain pathway through preferential conduction of vibration stimuli. Vibration, a safe and feasible option, can be the most effective proposition to reduce the neuropathic pain and enhance the quality of life in these patients. The device prototype has been developed with funding from the DST-supported NIDHI PRAYAS project, entitled “Development of a Wearable Device for Neuropathic Pain Control in Trigeminal Neuralgia Patients,” sanctioned on May 7, 2024. The proposed device operates in conjunction with the well-established gate control theory of pain modulation. By utilising vibrotactile stimulation, the device aims to inhibit pain pathways by preferentially conducting vibrotactile stimuli, effectively "closing the gate" to pain signals.

 
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