Effect of Yoga on Pain and Daily functions in Trigeminal Neuralgia

The proposed trial will be a Prospective, parallel group  open-label randomized controlled trial. The study protocol was created incompliance with the Standard Protocol Items: Recommendations for Interventional Trials  guidelines. The trial will be prospectively registered in clinical trial registration of India. After completion of the trial the findings will be reported as per the Consolidated Standards of Reporting Trials  guidelines.

The patients will be screened at Department of Neurology and TN clinic at Centre of Dental Education and Research and Pain clinic at AIIMS New Delhi for patient recruitment, enrolment and randomization. Intervention, Assessment of the patient along with the follow up will be done at Centre for Integrative Medicine and Research All India Institute of Medical Sciences, New Delhi.

Patients will be recruited from various departments of the All India Institute of Medical Sciences New Delhi including the Neurology Department, TN Clinic at CDER. After discussing the trial in detail, for interested participants, the informed consent process will be completed by the Principal Investigator, or designated trained research staff.All procedures and interventions will be undertaken shall conform to the Indian Council of Medical Research Good Clinical Practice Guidelines and the principles of the Helsinki declaration. Ethical approval will be obtained from the institutional ethical committee at AIIMS, New Delhi.

The participants will only be enrolled after obtaining written informed consent forms.The participant information sheet  mentioning the details including a brief description of  the trial, their voluntary participation, benefits, and related risks if any will be provided to the participants for better understanding of the trial. English and Hindi versions of both PICF and PIS will be available for the participants. Legally acceptable representative  consent will be obtained from the participant who cannot understand the language. LAR if invited by the participant, can be a parent, friend, or neighbour who understands either English or Hindi and will be able to give consent. The logs will also be maintained to record the number of participants screened, enrolled, and screen failure. The screening log will be used for documenting the record of all participants screened during the enrolment period. The enrolment log will be maintained to document the record of enrolled participants . The Screen Failure Log will be maintained to document the record of the screen failure participants. All the participants will be selected based on the inclusion and exclusion criteria. Post randomisation the participants will be divided into intervention that is yoga arm  and control that is standard medical treatment. The Primary outmode is measured using Penn facial tool and and secondary outcomes will be measured using Hospital Anxiety and Depression Scale and Pittsburg sleep quality index. Episodic pain frequency and medication adjusted dosage will also be measured using patient TN diary and log book.The participants will be assessed at baseline and 3 months post intervention. The final data collection period will be at least 48 hours after the last intervention.Potential adverse events will be recorded using log books. The data will be collected in a preplanned proforma. All procedures for the handling and analysis of data will be conducted as per institutional guidelines for the handling and analysis of data for clinical trials.The confidentiality of data will be maintained throughout the study period. All amendments to the study protocol will be notified to the institute ethics committee.The confidentiality of the participant will be ensured by unique identifiers and identifiable information if any will be removed. The data will be maintained in secured database that will be password protected on a secured computer and hard copies of records will be kept in a secured locked place. Patient information will be accessible only to a single primary investigator and stored confidentially.