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Effect of laser photobiomodulation with Carbamazepine in relieving pain in Trigeminal Neuralgia

Therapeutic effect of adjunctive 940nm diode laser photobiomodulation with carbamazepine on pain , infrared orofacial thermography and oral health quality of life in Trigeminal Neuralgia: A randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072573
Enrollment
236
Registered
2024-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Photobiomodul
ation with 940nm diode laser with carbamazepine: All patients will receive 200mg of carbamazepine twice daily along with Photobiomodulation with 940nm diode laser with the following parameters
Peak Power:0.2 Watts Power density:0.7 Watt/cm2 Fluenc:7.14 J/cm 2 per sitting Spot size:0.28cm2 Distance: Extraoral: At skin surface (Contact mode) Intraoral: 2mm from mucosal surface Mode Continuous

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All new diagnosed cases of Trigeminal neuralgia as per ICHD-3 criteria reporting to the department of OMR, CDER and willing to participate in the study will be included 2. Subjects diagnosed with Trigeminal neuralgia with a VAS score more than or equal to 5 3. Subjects willing to complete the treatment sessions

Exclusion criteria

Exclusion criteria: TN on polypharmacotherapy 2. TN secondary to multiple sclerosis, tumor, CNS lesions, herpes zoster or any other causes other than oral surgery. 3. TN in solely V1 distribution and acute TN 4. Past invasive treatment (MVD, alcohol block, cryosurgery, radiofrequency thermocoagulation, glycerol rhizolysis, gamma knife and stereotactic radiosurgery etc.) 5. Subjects with other orofacial pain like odontogenic/sinus/ occular otologic pain/ infection,TMD’s, myofascial pain , atypical orofacial pain, Burning mouth syndrome, traumatic neuropathy, or other neurological, psychiatric, neuromuscular and sensory disorders 6. Subjects on anti-inflammatories, analgesics, anaesthetics or any other medication for neurological disorders 7. Subjects with uncontrolled systemic diseases, with abnormal haemogram, liver function tests and renal function tests. 8. Subjects with current or past history of malignancy. 9. Alcoholics, drug addicts and patients with pacemaker. 10. Subjects with scars, tattoos, moles, traumatic, ulcerative, pathological skin lesion, open wounds, ulcers, or inflammation on facial skin in V2, V3 distribution sites to be exposed to Laser PBMT. 11. Subjects with bone marrow suppression, hypersensitivity to carbamazepine and tricyclic compounds 12. Pregnant and lactating females

Design outcomes

Primary

MeasureTime frame
VAS score:Patients will be instructed to mark a single vertical line on a horizontally oriented, ungraduated 100-mm VAS labelled “no pain ? at the far left and “worst pain possible ? at the far right.Timepoint: Baseline, Day 3, Day 6, Day 9, Day 12, Day 15 before photobiomodulation therapy, Day2 and Day 30 post Photobiomodulation therapy

Secondary

MeasureTime frame
BNI score ( Barrow Neurological Institute)Timepoint: Day3, Day 6, Day 9, Day 12, Day 15 before photobiomodulation therapy; Day 2 and Day 30 post photobiomodulation therapy;Oral health impact profile -14 score (OHIP-14)Timepoint: Baseline before photobiomodulation therapy, Day 2 and Day 30 post photobiomodulation therapy;Orofacial thermographyTimepoint: Baseline before photobiomodulation therapy, Day 2 and Day 30 post photobiomodulation therapy;Pain frequency ( Pain diary)Timepoint: Baseline, Day3, Day 6, Day 9, Day 12, Day 15 before photobiomodulation therapy; Day 2 and Day 30 post photobiomodulation therapy;VAS score:Patients will be instructed to mark a single vertical line on a horizontally oriented, ungraduated 100-mm VAS labelled “no pain ? at the far left and “worst pain possible ? at the far right.Timepoint: Day3, Day 6, Day9, Day 12, Day 15 before Photobiomodulation therapy

Countries

India

Contacts

Public ContactDr Shugufta Khanam

All india Institute of Medical Sciences New Delhi

shalinigupta@hotmail.com9971904592

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026