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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  
Name  Address 
NIL  NA 
 
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  
Status 
Not Applicable 
 
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.”

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.

 
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