| CTRI Number |
CTRI/2018/02/012068 [Registered on: 22/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This is a study to test the effectiveness of electrical nerve stimulation treatment applying on superficial skin in patients having pain originating from nerves and muscles of facial region. |
|
Scientific Title of Study
|
A Comparitive study among treatment modalities of orofacial pain of neural and muscular origin with transcutaneous electric nerve stimulation therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Swathi |
| Designation |
Post graduate student |
| Affiliation |
Vishnu dental college |
| Address |
Room number-1,
Department of Oral medicine and Radiology,
Vishnu dental college,
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9550827030 |
| Fax |
08816250894 |
| Email |
gadadasuswathi5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Ramesh |
| Designation |
Professor |
| Affiliation |
Vishnu dental college |
| Address |
Room number-1,
Department of Oral medicine and Radiology,
Vishnu dental college,
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9440847997 |
| Fax |
08816250894 |
| Email |
drramesht@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Ramesh |
| Designation |
Professor |
| Affiliation |
Vishnu dental college |
| Address |
Room number-1,
Department of Oral medicine and Radiology,
Vishnu dental college,
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9440847997 |
| Fax |
08816250894 |
| Email |
drramesht@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu dental college,
Vishnupur,
Bhimavaram |
|
|
Primary Sponsor
|
| Name |
Dr G Swathi |
| Address |
Room number-1,
Department of Oral medicine and Radiology
Vishnu dental college,
Vishnupur,
Bhimavaram |
| 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 |
| G Swathi |
Vishnu dental college, |
block III
Room number-1,
Department of Oral medicine and Radiology
West Godavari
ANDHRA PRADESH |
9550827030
08816250894
gadadasuswathi5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vishnu institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Trigeminal neuralgia and
Myofacial pain dysfunction syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carbamezepine for trigeminal neuralgia and combination of Ibuprofen,Paracetmol and Chlorzoxazone for myofacial pain dysfunction syndrome |
For trigeminal neuralgia patients, carbamezepine 200mg twice daily is given for 2 weeks
For myofacial pain dysfunction syndrome patients,combination of Ibuprofen 400mg,Paracetmol 325mg,Chlorzoxazone 250 mg twice daily is given for 2 weeks along with occlusal correction. |
| Intervention |
Transcutaneous electric nerve stimulation |
Transcutaneous electric nerve stimulation with 0-11 pulse rate, pulse width of 1-11µsec for 30 min,alternate days for 2 weeks for trigeminal neuralgia patients
Transcutaneous electric nerve stimulation with 120Hz pulse rate, 120 µsec pulse width for 60min for every alternative day for 2 weeks along with occlusal correction
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with orofacial pain due to neural & muscular origin.
2. Patients who are willing to give written consent to be treated with TENS will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are having pacemakers or other implanted electrical devices.
2. Pregnancy and lactating mothers.
3. Patients with pain attributable to fracture to joint, dental surgery, neoplasm.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain intensity and measurement of it using Visual analogue score |
Reduction in pain intensity and measurement of it using Visual analogue score-15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of pain attacks per day |
Frequency of pain attacks per day-15 Days |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
05/01/2017 |
| Date of Study Completion (India) |
10/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, parallel group, active-controlled trial to test effectiveness of transcutaneous electric nerve stimulation therapy in trigeminal neuralgia and myofacial pain dysfunction syndrome patients on comparing with conventional treatment modalities of carbamazepine 200mg twice daily for trigeminal neuralgia and ibuprofen 400mg, paracetamol 325mg,chlorzoxazone 250 mg along with occlusal correction for myofacial pain dysfunction syndrome. The treatment protocol has to be carried out for 15 days time period for both study and control groups.this study will be performed in Department of Oral Medicine and Radiology, Vishnu dental college, Bhimavaram. The primary outcome will be pain reduction using the visual analogue score and secondary outcome will decrease in pain frequency per day. |