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

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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, <br/ ><br>Day2 and Day 30 post Photobiomodulation therapy

Secondary Outcome Measures

Name	Time	Method
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