| CTRI Number |
CTRI/2025/07/091969 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effects of LASER Therapy and Myofascial Release on Myogenic Temporomandibular joint dysfunction Dysfunction. |
|
Scientific Title of Study
|
Effect of LASER Therapy with and without Myofascial Release in Myogenic Temporomandibular Joint dysfunction. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Sharma |
| Designation |
PG Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no. 02, Ground floor, Physiotherapy department, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8629882469 |
| Fax |
|
| Email |
akanksha3813@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akanksha Sharma |
| Designation |
PG Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. |
| Address |
Room no. ,Ground floor , Physiotherapy department, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
akanksha3813@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amita Aggarwal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. |
| Address |
Room no. , Ground floor, Physiotherapy department, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita.aggarwal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Room No 3, Ground Floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala, Haryana-133207 |
|
|
Primary Sponsor
|
| Name |
Akanksha Sharma |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University Mullana, Ambala, Haryana 133207 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Amita Aggarwal |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala, Haryana-133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akanksha Sharma |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room no. 2 Ground floor Department of physiotherapy Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana.
Ambala
HARYANA |
8629882469
akanksha3813@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Institute of Medical Scrences and Research Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low level LASER Therapy with myofascial release |
The treatment will be delivered for 3 days a week for 2 weeks, total of 6 sessions. |
| Comparator Agent |
Myofascial release |
Myofascial release technique on Temporalis, Masseter and sternocleidomastoid muscles, with 1 set of 3 repetitions with 90 seconds hold. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
General population with Myogenic TMJ dysfunction
Pain of muscle origin with referral of pain beyond the boundary of the muscle
Willing to participate
|
|
| ExclusionCriteria |
| Details |
• Active Infection.
Epilepsy
Fractures
Photosensitivity
Open wounds
Severe Psychological conditions
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TMJ Disability Index Questionnaire. |
The outcomes will be accessd at baseline and at the end of 6 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) |
The outcomes will be accessd at baseline and at the end of 6 sessions |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
29/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Temporomandibular
disorders (TMD) is one of the common diseases, which is a group of syndromes
characterized by pain, limited mandibular movement and joint clicking. It is a
multifaceted disorder impacting the temporomandibular joint (TMJ), causing
substantial discomfort and functional limitations. Myogenous
temporomandibular disorders (or masticatory myalgia)
are characterized by pain and dysfunction that arise from pathologic and
functional processes in the masticatory muscles. This study will evaluate the effect of LASER Therapy and Myofascial
release technique in Myogenic temporomandibular joint dysfunction. Patient will be recruited based on random number sampling subjects will
be divided into two groups Group A will be given LASER Therapy and Myofascial
release technique Group B will be given Myofascial release technique. Pre and
post assessment for pain, will be taken using VAS and TMJ disability index
questionnaire at baseline and end of 2 weeks. |