| CTRI Number |
CTRI/2025/12/099867 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| 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
|
Effect of Different Doses of Laser Therapy Along with drug Carbamazepine in Patients with Trigeminal Neuralgia (painful tic of face) |
|
Scientific Title of Study
|
Dose dependent efficacy of adjunctive photobiomodulation with carbamazepine in 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 Adit |
| Designation |
Professor, Oral Medicine and Radiology |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Oral Medicine and Radiology, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451525522 |
| Fax |
|
| Email |
adit@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adit |
| Designation |
Professor, Oral Medicine and Radiology |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Oral Medicine and Radiology, Institute of Medical 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, Oral Medicine and Radiology |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Oral Medicine and Radiology, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451525522 |
| Fax |
|
| Email |
adit@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Unit of Oral Medicine and Radiology, Faculty of Dental sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh- 221005 |
|
|
Primary Sponsor
|
| Name |
DR ADIT |
| Address |
Oral Medicine and Radiology
Faculty of Dental Sciences
Institute of Medical Sciences
Banaras Hindu University
Varanasi
PIN 221005
Uttar Pradesh |
| 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 |
Room 1, Unit of Oral Medicine and Radiology, Faculty of dental Sciences, Institute of Medical Sciences, Banaras Hindu University
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: G500||Trigeminal neuralgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
810 nm PBM at 12J/point with Carbamazepine 200 mg/day |
Patients will be irradiated with 810 nm diode LASER over trigger zones and involved dermatome, thrice weekly for 3 weeks, at 200 mW power for 30 sec per point, i.e. 12J energy per point. Along with this the patients will receive carbamazepine 200 mg/day. |
| Intervention |
810 nm PBM at 6J/point with Carbamazepine 200 mg/day |
Patients will be irradiated with 810 nm diode LASER over trigger zones and involved dermatome, thrice weekly for 3 weeks, at 200 mW power for 30 sec per point, i.e. 6J energy per point. Along with this the patients will receive carbamazepine 200 mg/day. |
| Comparator Agent |
810 nm PBM at 9J/point with Carbamazepine 200 mg/day |
Patients will be irradiated with 810 nm diode LASER over trigger zones and involved dermatome, thrice weekly for 3 weeks, at 200 mW power for 45 sec per point, i.e. 9J energy per point. Along with this the patients will receive carbamazepine 200 mg/day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients clinically diagnosed with Trigeminal Neuralgia according to IHS classification ICHD-3.
Patients willing to participate who have given informed consent for the study.
Patients with blood parameters (CBC, LFT) within normal limits. |
|
| ExclusionCriteria |
| Details |
Pregnant females and lactating mothers
Patients with evidence of vascular compression of trigeminal nerve or any other intracranial pathology on 3.0T MRI brain scan
Patients previously treated for trigeminal neuralgia within 1 year of first visit. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score (Numeric Rating Scale- NRS) |
Baseline, 1 week, 2 week, 3 week, 4 week, 2 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barrow Neurological Institute (BNI) Pain Intensity Scale |
Baseline, 1 week, 2 week, 3 week, 4 week, 2 month, 3 month |
| McGill Pain Questionnaire (MPQ) |
Baseline, 1 week, 2 week, 3 week, 4 week, 2 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/01/2026 |
| 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="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
|
Source of data- Data will be collected from patients reporting to the Out-Patient Unit of Oral Medicine and Radiology in the Faculty of Dental Sciences, I.M.S., B.H.U. Patients fulfilling the inclusion criteria will be selected. Diagnosis of Trigeminal Neuralgia would be based on the IHS Classification ICHD-3. Method of collection of data: Sampling technique- Simple random sampling Sample size determination- The sample size was estimated using the formula for comparing two independent means, which was rounded up to 16 patients per group. With three treatment groups, the total sample size required was 48. Allowing for an anticipated 20% dropout rate, the final target sample size was set at 20 patients per group, for a total of 60 participants. Study design- Randomized controlled trial Patient selection criteria: Inclusion criteria 1. Patients clinically diagnosed with TN according to the IHS Classification ICHD-3. 2. Both males and females. 3. Patients willing to participate who have given informed consent for the study. 4. Patients with blood parameters (CBC, LFT) within normal limits. Exclusion criteria 1. Pregnant females. 2. Patients with abnormal CBC and liver function tests. 3. Patients with evidence of significant vascular compression of the trigeminal nerve or any other intracranial pathology on 3.0 T MRI brain evaluation. 4. Patients with previous history of treatment for TN within 1 year. Duration of study– 6 months. Materials: 1. Basic examination kit 2. 810 nm GaAlAs diode laser device with photobiomodulatory tip and accessories 3. Surgical skin marker Methods: 1. Diagnosis of trigeminal neuralgia will be made on basis of clinical findings in line with the IHS Classification ICHD-3. 2. The treatment protocol will be explained to patients diagnosed with TN and with normal blood reports. Patients who provide informed consent will undergo a 3.0 T MRI of the brain to rule out significant vascular compression of the trigeminal nerve root or any other intracranial pathology. Only those without detectable abnormalities will be included in the study. 3. Baseline scoring of pain will be recorded using numeric rating scale (NRS) and Barrow Neurological Institute (BNI) Pain Intensity Scale. A baseline scoring of McGill Pain questionnaire (MPQ) will be done. Patients will also be instructed to maintain a daily attack diary recording paroxysm frequency, duration, triggers, and rescue medication use. 4. Patients will be randomized (computer-generated sequence, with allocation concealment) into three treatment arms, with age and sex stratification to ensure balanced distribution. 5. Carbamazepine pharmacotherapy at 200 mg/day will be prescribed to all patients across the groups at the start of treatment. No other centrally acting anticonvulsant or muscle relaxant drugs (e.g., gabapentinoids, baclofen) will be allowed during the study period. As rescue medication during increased pain, tab. acetaminophen (<2g/ day) can be taken and recorded by the patient. 6. All patients will receive an adjunctive photobiomodulation therapy with 810 nm diode laser over trigger zones and involved dermatome, thrice weekly for 3 weeks. Patients in Group 1, Group 2, and Group 3 will receive PBM therapy at 200 mW for 30 s (6 J/point), 45 s (9 J/point), and 60 s (12 J/point) per point, respectively. 7. NRS, BNI and MPQ scoring will be recorded at the end of each week for the first month, then at the end of 2nd and 3rd month for all patients. |