| CTRI Number |
CTRI/2023/05/052453 [Registered on: 10/05/2023] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of Transcutaneous Electrical Nerve Stimulation (TENS) and astaxanthin in Myofascial Pain Dysfunction Syndrome (MPDS)
|
|
Scientific Title of Study
|
Comparative evaluation of efficacy of Transcutaneous Electrical Nerve Stimulation (TENS), Transcutaneous Electrical Nerve Stimulation with Muscle relaxant, Transcutaneous Electrical Nerve Stimulation with Astaxanthin and Astaxanthin alone in the management of Myofascial Pain Dysfunction Syndrome (MPDS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smriti Jagdhari Golhar |
| Designation |
PhD Scholar |
| Affiliation |
Sharad Pawar Dental College And Hospital |
| Address |
department of oral medicine and radiology
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766640600 |
| Fax |
|
| Email |
drsmritigolhar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aarti Panchbhai |
| Designation |
professor |
| Affiliation |
Sharad Pawar Dental College And Hospital |
| Address |
department of oral medicine and radiology
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822220023 |
| Fax |
|
| Email |
artipanch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smriti Jagdhari Golhar |
| Designation |
PhD Scholar |
| Affiliation |
Sharad Pawar Dental College And Hospital |
| Address |
department of oral medicine and radiology
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766640600 |
| Fax |
|
| Email |
drsmritigolhar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe institue of Medical science, Sawangi,Wardha Maharashtra-442004 |
|
|
Primary Sponsor
|
| Name |
smriti jagdhari |
| Address |
SPDC, DIMMS DU Sawangi |
| 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 Smriti Jagdhari Golhar |
Sharad Pawar Dental College |
Department of Oral Medicine And Radiology
Wardha
MAHARASHTRA |
9766640600
drsmritigolhar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Astaxanthin |
antioxidant drug
8 mg Astaxanthin once a day for a month |
| Intervention |
Transcutaneous Electrical Nerve Stimulation (TENS) |
physiotheraputic modality
for 10 sessions, 3 sessions per week for 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
using Laskin’s criteria and DC/TMD Axis I and II criteria |
|
| ExclusionCriteria |
| Details |
• Patients Under management
• Patients with congenital anomalies of TMJ
• History of craniofacial trauma/fracture
• Any other diseases causing TMJ pain
• Congenital or degenerative changes of the spine
• Patients with mental disorders/stress
• Patients with pacemaker
• Pregnant females
• Patients with allergic to gel
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
relief from muscle pain and tenderness
increase in mouth opening |
from day one (Base line up to 2 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess quality of life |
baseline, 1 month and 2 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/05/2023 |
| Date of Study Completion (India) |
22/01/2026 |
| 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
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 27-04-2023 and end date provided 27-12-2024?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Written informed consent will be obtained from patients included in the study. Detailed case history of each patient will be carried out with recording of all the relevant information. All the included patients will be divided into two groups by simple randomization technique after elimination the preliminary cause. STUDY DESIGN – A Prospective, Randomized, intervention Clinical Study. 2. SOURCE OF DATA – Patient reporting in department of Oral & Medicine and Radiology of Dental Institute. 3. STUDY POPULATION – Physically fit human population with age between 18 to 60 years old. 4. SAMPLE SIZE – Total number of 30 patients were divided randomly in 4 groups as per the inclusion criteria. 5. SAMPLING TECHNIQUE – Simple Random Sampling GROUP I: will be treated with TENS for 10 sessions, 3 sessions per week for 10 minutes with one month follow-up. GROUP II: Patients will be treated for 10 sessions, 3 sessions per week for 10 minutes and mg Muscle relaxant will be given once a day for a month with one month follows up GROUP III: Patients will be treated for 10 sessions, 3 sessions per week for 10 minutes and 8 mg Astaxanthin will be given once a day for a month with one month follows up GROUP IV: Patients will be treated for 8 mg Astaxanthin once a day for a month with one month follows up During each visit patients will be examined for following clinical features 1. Range of motion (ROM)- a. Interincisal distance- It will be recorded in mm by vernier calliper from mesio-incisal angle of upper central incisor up to the mesio-incisal line angle of lower incisor on 1st and last day of treatment. b. Lateral excursion movements 16.On 1st and on the last day of treatment 2. Observation of pain intensity at rest, on movement of jaw –It will be assessed by visual analog scale (VAS) on 1st and on the last day of treatment 3. Palpation of muscle (grading based on scale for grades of tenderness): Grade of tenderness in various muscles at 1st and on the last day of treatment 4. SF-36 Quality of life Questionnaire 5. Estimation of pre and post evaluation of oxidative stress using serum marker |