| CTRI Number |
CTRI/2024/07/070214 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Trigeminal Neuralgia with Carbamazepine and Transcutaneous Electrical Nerve Stimulation. |
|
Scientific Title of Study
|
Comparative efficacy of carbamazepine therapy with and without transcutaneous electrical nerve stimulation therapy for the management of trigeminal neuralgia: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutumbara G Dhone |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Oral Medicine and Radiology (001) Ground Floor, Sharad Pawar Dental College and Hospital, Sawangi Meghe, 442001
Wardha MAHARASHTRA 442001 India |
| Phone |
8208653669 |
| Fax |
|
| Email |
rutumbaragdhone3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vidya Lohe |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Oral Medicine and Radiology (001) Ground Floor, Sharad Pawar Dental College and Hospital, Sawangi Meghe, 442001
Wardha MAHARASHTRA 442001 India |
| Phone |
9960445040 |
| Fax |
|
| Email |
vidyalohekadu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vidya Lohe |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Oral Medicine and Radiology (001) Ground Floor, Sharad Pawar Dental College and Hospital, Sawangi Meghe, 442001
MAHARASHTRA 442001 India |
| Phone |
9960445040 |
| Fax |
|
| Email |
vidyalohekadu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research,Sawangi Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rutumbara G Dhone |
Sharad Pawar Dental College and Hospital |
Department of Oral Medicine and Radiology (001), SPDC Building, Sawangi Meghe Wardha MAHARASHTRA |
8208653669
rutumbaragdhone3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G500||Trigeminal neuralgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carbamazepine Therapy |
Patient will be treated with Carbamazepine with an initial dose of 100 mg TDS per day (300 mg), will be titrated with additional 100 mg every 48 hrs until the patient achieves complete relief or reached the maximum tolerable dose. |
| Intervention |
Carbamazepine Therapy and Transcutaneous Electrical Nerve Stimulation |
Patient of age range of 20–80 years who are primarily diagnosed as Trigeminal Neuralgia. Patient will be treated with Carbamazepine with an initial dose of 100 mg TDS per day 300 mg, will be titrated with additional 100 mg every 48 hrs until the patient achieves complete relief or reached the maximum tolerable dose and Patient will be given TENS therapy for a total of 40 minutes per session, using a low frequency 2–10 Hz for the first 20 minutes and a high frequency 50–100 Hz for the next 20 minutes, without a rest period in between, with a pulse duration of 125 µs. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with a clinical diagnosis of idiopathic or classical TN.
2. Individuals who had never had treatment before.
3. Individuals who had not received TN treatment over the previous six months. |
|
| ExclusionCriteria |
| Details |
Individuals with compromised health,Pregnant women,
People with hypertension, Individuals who wear pacemakers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 The severity of pain may be reduced, which will be evaluated using a VAS score.
2 Duration of pain episodes measured in minutes may be reduced.
3 Frequency (Number of pain episodes) per day may be reduced. |
at baseline, 1 months, and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 one of the most painful diseases. Typically,
medication therapy starts at an initial titrated dose of 100 mg every other day
of carbamazepine (CBZ) 200–1200 mg/day. There is less evidence to support
second-line treatments such as clonazepam, valproic acid, baclofen, gabapentin,
lamotrigine, and baclofen. TENS is a widespread technique used for managing
neuropathic pain. TENS therapy, which involves the transmission of an
electric current across the intact skin surface to activate deeper nerves in an
attempt to relieve pain, is a recent and promising alternative for the
treatment of both acute and chronic pain. There few studies on TENS therapy
used to treat pain in TN. These
studies lacked control groups, had inadequate study designs, and provided
ambiguous information about the kind of drug therapy being taken concurrently.
Need of the study: TENS in combination with CBZ may reduce the
dose of CBZ therapy, therefore, there is a need to conduct the study on “Comparative
efficacy of CBZ therapy with and without TENS therapy for the management of
TN.â€
AIM: To evaluate and
compare the efficacy of CBZ therapy with and without TENS therapy for the
management of TN.
Materials and Methods:Once
diagnosed and enrolled, 38 individuals between the ages of 20
and 80 will receive a primary diagnosis of TN based on IHS diagnostic criteria
(IHS, 2004). Then these patients will randomly be allocated to one
of the following groups,19 subjects in each groups respectively:
1)
Group 1: CBZ
Therapy
2)
Group 2: CBZ with TENS therapy
Group 1 (CBZ Therapy):
The baseline parameters of patients will be evaluated who will be treated with CBZ Initially at 100 mg TDS per day (300 mg), the patient will receive an
additional titrated dose 100 mg of CBZ every 48 hours until they reach the
maximum tolerated dose or total relief.
Group 2 (CBZ with
TENS therapy): The pulse duration
will be 125 µs. The TENS will be applied during the first twenty minutes at a
low frequency (2–10 Hz) and the last twenty minutes at a high frequency (50–100
Hz), with no break in between.
Outcomes: 1.
The severity of pain may be reduced, which will be evaluated using a VAS score.
2.
Duration of pain episodes measured in minutes may be reduced.
3.Frequency
(Number of pain episodes) per day may be reduced. |