| CTRI Number |
CTRI/2025/03/082450 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A comprehensive prospective study on pain freedom after medical or surgical treatment for trigeminal neuralgia (TN) and atypical facial pain (AFP) |
|
Scientific Title of Study
|
A comprehensive prospective study on trigeminal neuralgia
(TN) and atypical facial pain (AFP) to evaluate surgical and
non-surgical management strategies.
|
| 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 Ashok Pillai |
| Designation |
Clinical professor and Neurosurgeon |
| Affiliation |
Amrita Institute of medical sciences and research centre |
| Address |
Department of neurosurgery
Amrita Institute of medical sciences and research centre,Ponekkara Road P O Kochi
Ernakulam
KERALA
682041
India |
| Phone |
07034028231 |
| Fax |
|
| Email |
brashok@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Pillai |
| Designation |
Clinical professor and Neurosurgeon |
| Affiliation |
Amrita Institute of medical sciences and research centre |
| Address |
Department of neurosurgery
Amrita Institute of medical sciences and research centre,Ponekkara Road P O Kochi
Ernakulam
KERALA
682041
India |
| Phone |
07034028231 |
| Fax |
|
| Email |
brashok@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Pillai |
| Designation |
Clinical professor and Neurosurgeon |
| Affiliation |
Amrita Institute of medical sciences and research centre |
| Address |
Department of neurosurgery
Amrita Institute of medical sciences and research centre,Ponekkara Road P O Kochi
Ernakulam
KERALA
682041
India |
| Phone |
07034028231 |
| Fax |
|
| Email |
brashok@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences and Research Centre, Ponekkara P. O, Edappally, Kochi, Kerala 682041
|
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Amrita Institute of Medical Sciences and Research Centre, Ponekkara P. O, Kochi, Kerala 682041 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrAshok PIllai |
Amrita Institute of Medical Science |
Department of neurology and neurosurgery. A block tower 1 floor 3.
Ernakulam
KERALA |
7034028231
brashok@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EthicsCommitteeofAmritaschoolofMedicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G501||Atypical facial pain, (2) ICD-10 Condition: G500||Trigeminal neuralgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Observational Study
No new experimental interventions are used |
| Intervention |
NIL |
Observational Study.No new experimental interventions are used |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have history and clinical presentation
consistent with IHS (International Headache Society
criteria ICHD-3 beta for trigeminal neuralgia (TN) and
non- TN atypical facial pain who visit the department of
neurology and neurosurgery at Amrita hospital.
2. Patients above 18 years who are willing to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Patients who are not interested to participate in the study.
2. Patients below 18 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain relief as assessed by visual analog scale (VAS), Neuropathy Sensory Symptom Scale and Neuropathy Total Symptom Score-6 scale. |
baseline visit and at months 3, 6, 12 and 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life factors using short form questionnaire (SF12) |
3, 6, 12 months |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
12/05/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The prospective design with standardised and systematic assessments of the patients and the set up as a real-life study is a major strength of this study. Real world data is difficult to acquire but does offer a more realistic view of the situation. This single centre prospective study will be further developed in to multicentric registry which will be aid for any trigeminal neuralgia and atypical facial pain based clinical research and 5 randomised controlled clinical trials in the future. Studies shows that, group of medically managed patients enrolled in a structured multidisciplinary management program was favourable, defined as a 50% reduction of the overall burden of pain over a two-year period. Continuous advice, education, and support from the multidisciplinary team, along with referral of medically intractable patients for surgery, play crucial roles in managing the natural history of the disease. The favourable prognosis offers hope and optimism for both patients and care providers, indicating that specialist management of the mentioned diseases will be highly rewarding.
This prospective cohort study will be conducted at the Department of neurology and neurosurgery at Amrita hospital. It will include all trigeminal neuralgia and atypical facial pain patients who express their interest to participate in the study by signing the informed consent document. Data collected will encompass demographic and clinical information obtained directly from patient interviews. This data will be recorded directly in the EDC system METAFLO. The entered data will be verified and validated by the PI or the PI’s designee according to the data management plan. The cleaned data will then be statistically analysed and utilized for publications.
The study will be conducted prospectively for 2 years with follow-up at 3, 6, and 12 months. |