| CTRI Number |
CTRI/2024/01/062070 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of TENS and Ultrasound in MPDS |
|
Scientific Title of Study
|
Comparative Evaluation of Therapeutic Ultrasound and Transcutaneous Electrical Nerve
Stimulation in Myo-Facial Pain Dysfunction Syndrome A Randomized control trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Maddheshiya |
| Designation |
senior resident |
| Affiliation |
Faculty of Dental Sciences IMS BHU Varanasi |
| Address |
Room no 1 unit of oral medicine and radiology Faculty of Dental Sciences IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7388322510 |
| Fax |
|
| Email |
nishagpt0211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nisha Maddheshiya |
| Designation |
senior resident |
| Affiliation |
FDS IMS BHU |
| Address |
Faculty of Dental Sciences IMS BHU Varanasi
Faculty of Dental Sciences IMS
BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7388322510 |
| Fax |
|
| Email |
nishagpt0211@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Maddheshiya |
| Designation |
senior resident |
| Affiliation |
FDS IMS BHU |
| Address |
Room no 1 unit of oral medicine and radiology Faculty of Dental Sciences IMS BHU Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7388322510 |
| Fax |
|
| Email |
nishagpt0211@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NISHA MADDHESHIYA |
| Address |
ROOM NO 1 UNIT OF ORA MEDICINE AND RADIOLOGY FDS IMS BHU VARANASI 221005 |
| 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 |
| NISHA MADDHESHIYA |
FACULTY OF DENTAL SCIENCES |
FACULTY OF DENTAL SCIENCES IMS BHU VARANASI 221005
Varanasi
UTTAR PRADESH |
7388322510
nishagpt0211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF MEDICAL SCIENCES BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MPDS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TENS |
Subjects will receive TENS for the duration of 15 min per session thrice a week for 4 weeks |
| Comparator Agent |
THERAPEUTIC ULTRASOUND |
Subjects will receive continuous and manual mode ultrasound therapy at frequency of 3.0 MHz to the area of interest for the duration of 15 min per session thrice a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from MPDS
Patients presenting with pain trismus and clicking without any radiological and pathological findings |
|
| ExclusionCriteria |
| Details |
Patients with recent TMJ dislocation, hairy surface, radiculopathy, or other neurological deficits.
Patients on any medication for MPDS
Patients undergone any cardiac surgery or any other systemic illness.
Pregnancy or breastfeeding women
Patients with other orofacial pain disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Rating Score (NRS) at baseline |
Numeric Rating Score (NRS) at baseline and after each follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maximum Mouth opening (in mm) measured at baseline and after completion of treatment.
Lateral movement of the jaw (in mm) measured at baseline and after completion of treatment.
|
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 study is randomized parallel control trial comparing the numeric rating scale at baseline along with maximal mouth opening and lateral movement of the jaw in MPDS patients. A total of 46 subjects has been taken in two divided groups randomly according to the inclusion criteria and the study will be explained to them before starting the treatment. Group A Subjects will receive TENS for the duration of 15 min per session thrice a week for 4 weeks. Patient will be followed up for another 4 weeks after completion of treatment. The stimulation will be given to the patient in sitting position; surface electrodes will be placed on tender muscles of face and neck region. Group B Subjects will receive continuous and manual mode ultrasound therapy at frequency of 3.0 MHz at 1.4 W/m2 to the area of interest for the duration of 15 min per session thrice a week for 4 weeks and patient will be followed up for another 4 weeks after completion of treatment. Numeric rating score (NRS) will be recorded at baseline and after each follow up period. Maximum mouth opening and lateral movement of jaw in terms of mm will be recorded at baseline and after completion of treatment. |