| 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
|
|
|
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
|
|
|
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
|
|
|
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. |