| CTRI Number |
CTRI/2023/08/056466 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomised Controlled Trial To Compare The Effectiveness Of Therapeutic Ultrasound And Pulsed Shortwave Therapy Along With Physiotherapy In The Management Of Temporomandibular Disorders. |
|
Scientific Title of Study
|
Comparative Evaluation Of Effectiveness Of Therapeutic Ultrasound And Pulsed Shortwave Therapy Along With Physiotherapy In Management Of Temporomandibular Disorders: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha Damodar Chincholkar |
| Designation |
PG Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh smruti dental college and hospital Wanadongri, Nagpur. |
| Address |
Ground floor, room no.3, Department of Oral medicine and Radiology. Swargiya Dadasaheb Kalmegh Dental College and Hospital, Wanadongri, Nagpur
Ground floor, room no.3, Department of Oral medicine and Radiology. Swargiya Dadasaheb Kalmegh Dental College and Hospital, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9689531308 |
| Fax |
|
| Email |
drshraddhachincholkar20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashish Lanjekar |
| Designation |
Head of the Department |
| Affiliation |
Swargiya Dadasaheb Kalmegh smruti dental college and hospital Wanadongri, Nagpur. |
| Address |
Ground floor, room no.3, Department of Oral medicine and Radiology. Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur
Ground floor, room no.3, Department of Oral medicine and Radiology. Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur
MAHARASHTRA
441110
India |
| Phone |
9595052481 |
| Fax |
|
| Email |
ashish.lanjekar@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shraddha Damodar Chincholkar |
| Designation |
PG Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh smruti dental college and hospital Wanadongri, Nagpur. |
| Address |
Ground floor, room no.3, Department of Oral medicine and Radiology. Swargiya Dadasaheb Kalmegh Dental College and Hospital, Wanadongri, Nagpur
Ground floor, room no.3, Department of Oral medicine and Radiology. Swargiya Dadasaheb Kalmegh Dental College and Hospital, Wanadongri, Nagpur
MAHARASHTRA
441110
India |
| Phone |
9689531308 |
| Fax |
|
| Email |
drshraddhachincholkar20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh smruti Dental College and Hospital, Wanadongri, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Shraddha Damodar Chincholkar |
| Address |
Ground floor, room no.3, Department of Oral medicine and Radiology. Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur |
| 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 |
| Dr Shraddha D Chincholkar |
Swargiya Dadasaheb Kalmegh smruti Dental College and Hospital, Wanadongri, Nagpur |
Ground floor, room no.3, Department of Oral medicine and Radiology. Swargiya Dadasaheb Kalmegh smruti Dental College and Hospital, Wanadongri, Nagpur
Nagpur
MAHARASHTRA |
9689531308
drshraddhachincholkar20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pulsed Short wave Therapy with Physiotherapy. |
Pulsed shortwave therapy (PSWT) is a non-invasive therapy that relies on tissue
exposure to high-frequency and nonthermal electromagnetic energy with the goal of providing analgesia to both acute postoperative and chronic pain. With regard
to osteoarthritis, PSWT has been demonstrated to reduce pain, reduce the need
for pharmacotherapy and improve physical functionality. When used as an
adjunctive therapy, PSWT has also been shown to be effective in reducing pain for
a number of chronic conditions within 7 days of initial use, with durability of treatment extending for at least 6 months. PSWT or Actipatch is a closed loop system consisting of an antenna of about 30cm2 with a low energy signal generator circuit and a 3-V battery power supply. The frequency is about 27.12 MHz with a pulse rate of about 1000 Hz. Pulsed Short-Wave Therapy will be given for 60 min per day over 5 consecutive days.Pain will be evaluated using VAS and Mouth opening will be measured using a Electronic Vernier calliper on baseline, 2nd ,3rd, 4th weeks.
Physiotherapy exercises will be advised to the patient which includes isometric mouth exercises, mouth stretching exercises, and resistive
mouth exercises, with each exercise to be performed for 6 seconds with 10 repetitions,for 4 weeks.
|
| Comparator Agent |
Therapeutic Ultrasound with Physiotherapy |
Ultrasound is defined as sound waves with frequencies that are higher than 20 kHz, which is the maximum threshold of human hearing ability. Therapeutic ultrasound is a non - invasive physical therapy modality. The main two goals of therapeutic ultrasound are to reduce pain intensity and to increase mandibular range of motion. Therapeutic ultrasound is thought to achieve these two goals by two mechanisms the first mechanism is by increasing the tissue temperature and second mechanism is by the effect of the cyclic nature of the ultrasound.Part of ultrasound energy is absorbed by tissue and that increase in the tissue is thought to be beneficial to the patient by increasing the stretching ability of collagen fibers, relieving pain, decreasing muscle spasm, decreasing joint stiffness, improving the extensibility of collagenous structure of the tissue, and improving tissue blood flow. Ultrasonic massage therapy with a frequency of 1 MHz and pulse setting at 1:1.Therapeutic Ultrasound will be given for single session of 8 min, once a week for 4 consecutive weeks.
Pain will be evaluated using VAS and Mouth opening will be measured using a Electronic Vernier calliper on baseline, 2nd ,3rd, 4th weeks.Physiotherapy exercises will be advised to the patient which includes isometric mouth exercises, mouth stretching exercises, and resistive mouth exercises, with each exercise to be performed for 6 seconds with 10 repetitions, for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged above 18 years.
2. Patients with symptomatic temporomandibular disorder along with reduced
mouth opening diagnosed with Myositis and myofascial pain dysfunction
syndrome. |
|
| ExclusionCriteria |
| Details |
1. Traumatic conditions of TMJ region.
2. Patients with degenerative diseases involving TMJ.
3. Patients with any congenital defect in TMJ.
4. Patients with cardiac pacemakers and cardiac arrhythmias.
5. Pregnant women.
6. Patient suffering from benign and malignant neoplastic condition of TMJ
disorders, mentally disabled patients.
7. Patients with undiagnosed dental pain or who have skin lesions or facial
abrasion at the site of acoustic gel placement.
8. Patients not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulsed short wave therapy with physiotherapy is more effective than therapeutic
ultrasound with physiotherapy in management of TMD |
Pain will be evaluated using VAS & Mouth opening will be measured
using an Electronic Vernier calliper on baseline, 2
nd ,3rd, 4th weeks in both
groups.
Physiotherapy exercises will be advised to the patient which includes
isometric mouth exercises, mouth stretching exercises, & resistive
mouth exercises, with each exercise to be performed for 6 seconds with
10 repetitions, for 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare the effectiveness of PSWT & Therapeutic ultrasound
along with physiotherapy in management of TMD in terms of pain relief &
improvement in mouth opening. |
Pain will be evaluated using VAS & Mouth opening will be measured
using an Electronic Vernier calliper on baseline, 2
nd ,3rd, 4th weeks in both
groups.
Physiotherapy exercises will be advised to the patient which includes
isometric mouth exercises, mouth stretching exercises, & resistive
mouth exercises, with each exercise to be performed for 6 seconds with
10 repetitions, for 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/08/2023 |
| 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="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
COMPARATIVE EVALUATION OF EFFECTIVENESS OF THERAPEUTIC ULTRASOUND AND PULSED SHORTWAVE THERAPY ALONG WITH PHYSIOTHERAPY IN MANAGEMENT OF TEMPOROMANDIBULAR DISORDERS: A RANDOMIZED CONTROLLED TRIAL. A consecutive sample of 48 subjects fulfilling eligibility criteria and seeking treatment and care at the study hospital will be selected by convenience sampling method and equally allotted to two study groups. The 24 subjects will be equally allocated into 2 groups i) Group A - Patients undergoing therapeutic ultrasound with physiotherapy. ii) Group B - Patients undergoing PSWT with physiotherapy. A detailed case history will be taken from all the patients and will be recorded in the predesigned proforma after patients written consent and approval from the Institutional ethical committee. Only those patients who are willing to participate will be considered in the study. Total 48 clinically diagnosed patients with Temporomandibular disorders will be enrolled in the study. All the patients will be explained the need and design of study. Diagnosis of TMD was made based upon research diagnostic criteria (RDC) for clinical TMDs conditions. Group A patients (24 subjects) will be given Therapeutic Ultrasound which comprises of single session of 8 min, once a week for 4 consecutive weeks. Group B patients (24 subjects) will be given Pulsed Short-Wave Therapy for 60 min per day over 5 consecutive days. Pain will be evaluated using VAS and Mouth opening will be measured using a Electronic Vernier calliper on baseline, 2 nd ,3rd, 4th weeks in both groups. Physiotherapy exercises will be advised to the patient which includes isometric mouth exercises, mouth stretching exercises, and resistive mouth exercises, with each exercise to be performed for 6 seconds with 10 repetitions, for 4 weeks. |