| CTRI Number |
CTRI/2024/06/068319 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of combined laser and carbamazepine with only carbamazepine in patients with trigeminal neuralgia : a randomised controlled trial |
|
Scientific Title of Study
|
Comparative evaluation of therapeutic and analgesic effect of combined laser and carbamazepine with carbamazepine alone in patients with trigeminal neuralgia : a randomised 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 |
Saumya Shukla |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room No. 1, Unit of Oral Medicine and Radiology,
Faculty of Dental Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9559399493 |
| Fax |
|
| Email |
drsaumya.rs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adit |
| Designation |
Professor and Head, Unit of Oral Medicine and Radiology |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room No. 1, Unit of Oral Medicine and Radiology,
Faculty of Dental Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451525522 |
| Fax |
|
| Email |
adit@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adit |
| Designation |
Professor and Head, Unit of Oral Medicine and Radiology |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room No. 1, Unit of Oral Medicine and Radiology,
Faculty of Dental Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451525522 |
| Fax |
|
| Email |
adit@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences,
Banaras Hindu University,
Varanasi - 221005
Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Saumya Shukla |
| Address |
Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Banaras Hindu University |
| Type of Sponsor |
Other [Self] |
|
|
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 Adit |
Faculty of Dental Sciences |
Unit of Oral Medicine and Radiology, Room No. 1, Faculty of Dental Sciences, Banaras Hindu University,
Varanasi - 221005
Varanasi
UTTAR PRADESH |
9451525522
adit@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G448||Other specified headache syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carbamazepine 100 mg |
Oral Carbamazepine 100 mg given twice daily with increase in dosage by 100 mg based on severity of pain.
Follow-up of 3 months. |
| Intervention |
Photobiomodulation therapy as an adjunct to Carbamazepine 100 mg. |
Photobiomodulation therapy using a diode laser of 810 nm wavelength will be given to points (extraoral and/or intraoral) as indicated by the patient along the course of the affected branch of the trigeminal nerve at a power of 200 mW for 30s with intensity of 6J/cm square twice weekly, along with oral carbamazepine 100 mg twice daily with increase in dosage by 100 mg based on severity of pain. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients clinically diagnosed with TN according to the IHS Classification ICHD-3.
2. Both males and females.
3. Patients who have given informed consent for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in the study.
2. Pregnant females.
3. Patients with abnormal CBC and liver function tests.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain intensity using McGill Pain Questionnaire. |
baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for 50% pain reduction using VAS |
twice weekly for initial 4 weeks , 1 month, 2 months and 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/06/2024 |
| 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="0"
Months="6"
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
|
1. Diagnosis of Trigeminal Neuralgia will be made on basis of clinical findings in line with the IHS Classification ICHD-3. 2. Explanation of the treatment protocol will be given to the patient and informed consent will be taken. 3. Baseline scoring of pain (using VAS) will be done. 1. Laser therapy will be performed at the trigger points, based on previous studies we will use laser and carbamazepine in case groups for treatment of TN. 2. Due to ethical considerations, patients in both groups will be subjected to standard pharmaceutical therapy with 100 mg carbamazepine at the onset of treatment and then another 100 mg after 2 days based on severity of pain in patients. This process will be continued until pain is alleviated taking into account the maximum safe dose of carbamazepine. 3. Low level laser therapy (LLLT) along with pharmaceutical therapy will be performed for the case group. Only pharmaceutical therapy shall be given to the control group. 4. The case group shall receive 9 sessions, 3 days a week. The severity of pain will be recorded prior to laser therapy, immediately after each session of laser therapy and one month after completion of treatment using the VAS. The pain scores will be recorded in McGill Pain Questionnaire, with follow-up at 1, 2 and 3 months. 4. Patients will be divided into 2 groups of cases and controls using block randomization. |