| CTRI Number |
CTRI/2025/06/089635 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Homeopathy
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Infrared massage therapy with arnica for TMD. |
|
Scientific Title of Study
|
Comparing the efficacy of Infrared mechanical massage therapy with and without Arnica Gel application - A New Way to Relieve TMD Pain - A randomized clinical 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 |
Benjamin Rajasekar A |
| Designation |
Post Graduate |
| Affiliation |
SRM Dental College Ramapuram |
| Address |
SRM Dental College Ramapuram Campus, Tamil Nadu, Chennai - 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
07010619582 |
| Fax |
|
| Email |
benjaminandrew1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. C L Krithika |
| Designation |
Associate Professor |
| Affiliation |
SRM Dental College Ramapuram |
| Address |
SRM Dental College Ramapuram Campus, Tamil Nadu, Chennai - 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9444333977 |
| Fax |
|
| Email |
krithika.sekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Benjamin Rajasekar A |
| Designation |
Post Graduate |
| Affiliation |
SRM Dental College Ramapuram |
| Address |
SRM Dental College Ramapuram Campus, Tamil Nadu, Chennai - 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
07010619582 |
| Fax |
|
| Email |
benjaminandrew1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental College, Ramapuram Campus
Barathi Salai, Ramapuram, Chennai - 600089 |
|
|
Primary Sponsor
|
| Name |
Benjamin Rajasekar. A |
| Address |
SRM Dental College
Ramapuram Campus
Bharathi Salai, Ramapuram,
Chennai – 600 089 |
| 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 Benjamin Rajasekar |
SRM Dental College |
Department of Oral Medicine and Radiology - 1
SRM Dental College
Ramapuram Campus
Bharathi Salai, Ramapuram,
Chennai – 600 089
Chennai
TAMIL NADU |
07010619582
benjaminandrew1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD SRM DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Beurer MG 21 Infrared Massager |
Hand massager with vibration and Infrared heat |
| Comparator Agent |
Placebo |
placebo |
| Intervention |
SBL Arnica Gel and Infrared mechanical massager |
SBL Arnica gel which contains Arnica montana & ParaffinumMolle. Hand massager with vibration and Infrared heat |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
- Diagnosis of chronic local myalgia with average reported pain greater than or equal to 3 on the numeric verbal scale
- Availability to participate in the study
- Both male and female of any age group who are willing to participate
|
|
| ExclusionCriteria |
| Details |
- Diagnosed with widespread pain
- Diagnosis of joint disorders
- Presence of open wounds/eczema on the skin or the skin membranes involved in the treatment
- Diagnosis of arteriosclerosis, thrombosis, cardiac arrhythmias, or use of a pacemaker
- Diagnosis of epilepsy
- Use of brain stimulators or presence of metal implants
- Presence of tumour lesions
- Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Visual Analog Scale (VAS) score before and after treatment |
VAS measured immediately after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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="0"
Months="2"
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
|
This randomized clinical trial aims to compare the efficacy of infrared mechanical massage therapy with and without Arnica gel application in reducing pain among patients with temporomandibular disorders (TMD). Participants will be randomly allocated into two groups: one receiving infrared massage alone and the other receiving infrared massage with Arnica gel. The primary outcome measure is the change in pain intensity assessed using the Visual Analog Scale (VAS). The study will be conducted in a single session with pre- and post-treatment assessments. The outcome assessor will be blinded to the group allocation to minimize bias |