| CTRI Number |
CTRI/2025/04/083986 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of three muscle releasing techniques for Jaw Pain and its Movement Issue |
|
Scientific Title of Study
|
Effect of Muscle Energy Technique, Cyriax Technique and Positional Release Technique on pain, mobility and functional limitation in patient with temporal mandibular 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 |
Varsha Sharma |
| Designation |
MPT Student |
| Affiliation |
Gurugram University ,sector 87 , kankrola |
| Address |
Department of Physiotherapy, Gurugram University, sector 87, Kankrola
Department of Physiotherapy, Gurugram University, sector 87, Kankrola
Gurgaon
HARYANA
122505
India |
| Phone |
9996228100 |
| Fax |
|
| Email |
business.varshasharma006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurpreet singh |
| Designation |
Assistant Professor |
| Affiliation |
Gurugram University, sector 87 ,kankrola |
| Address |
Department of Physiotherapy, Gurugram University, sector 87, Kankrola
Department of Physiotherapy Gurugram University,sector 87 , kankrola
Gurgaon
HARYANA
122505
India |
| Phone |
9350567067 |
| Fax |
|
| Email |
physio11r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurpreet singh |
| Designation |
Assistant Professor |
| Affiliation |
Gurugram University, sector 87 ,kankrola |
| Address |
Department of Physiotherapy, Gurugram University , sector 87, Kankrola
Department of Physiotherapy,Gurugram University ,sector 87 , kankrola
Gurgaon
HARYANA
122505
India |
| Phone |
9350567067 |
| Fax |
|
| Email |
physio11r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Gurugram University,sector-87, Kankrola Village, Gurugram |
|
|
Primary Sponsor
|
| Name |
Gurugram University |
| Address |
Sector 87 , Gurugram , kankrola
Pincode -122505 |
| Type of Sponsor |
Other [University ] |
|
|
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 Varsha Sharma |
Quality Physio Advanced Chiropractor Physiotherapy and Rehabilitation Center |
Sector 48, Gurugram 122018,Haryana
Gurgaon
HARYANA |
9996228100
business.varshasharma006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Department of Physiotherapy |
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 |
| Comparator Agent |
Cyriax technique |
Patients in Group B received : Cyriax technique : Palpate the muscle to locate tender areas.Application: Use firm transverse frictional strokes perpendicular to the muscle fibers.Perform for 10 minutes, ensuring pressure remains within the patient’s tolerance. |
| Intervention |
Muscle energy technique |
Patients in Group A received: Met ( muscle energy technique : Muscle Energy Technique (MET) for TMJ dysfunction involves gentle isometric contractions to improve jaw mobility and reduce pain. The patient applies effort against resistance for 10 seconds, followed by relaxation. The therapist then guides the jaw into a new position to increase the range of motion. This process is repeated several times to release tight muscles and improve function. |
| Intervention |
Postional release technique |
Patients in Group C received: PRT (positional release
technique)with Patient lying supine and therapist standing
besides the patient and applying Positional release technique
for masseter , temporalis and digastric muscles in which muscles are
placed in the position of great comfort with dosage of Total 5
times/ session, 5 SEC rest, and 3 times/week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Chronic conditions of temporomandibular joint Dysfunction more than 3 months
2.Temporomandibular disorder pain on function, joint tenderness, restricted jaw movement, clicking ,jaw locking, tenderness in muscles of mastication ,
3. Subjects suffering from Oral Submucous Fibrosis (OSMF)
4 .Subjects with jaw functional limitations scale-20 scores with 160-180
5.Subjects with pain intensity between 3-7
6.Subjects reduce mouth opening 30-35mm
7.Subjects with age 20-40 year
8.Both males and females participate |
|
| ExclusionCriteria |
| Details |
1.Osteoporosis in Temporomandibular joint
2.Neurological impairment in Temporomandibular joint
3.Degenerative Inflammation Temporomandibular joint Arthritis
4.Any history of dislocation of Temporomandibular joint
5.Metallic implants and Metallic braces on teeth
6.Acute RCT ( ROOT CANAL TREATMENT ) of teeth within 7 days
7.Recent trauma (accident) within 7-10 days
8.Oncology patient (tumor )
9.Patient not fit into inclusion criteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Intensity
Joint Mobility
|
baseline after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FUNCTIONAL LIMITATIONS |
baseline after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
14/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="28" |
|
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
|
AIM AND OBJECTIVES Primary objective: To compare the effective of Muscle energy technique , Cyriax technique and Positional release technique in Temporomandibular joint Dysfunction patient Secondary objective: To reduce pain in patients suffering from Temporomandibular Joint Dysfunction. To improve joint mobility of Temporomandibular Joint Dysfunction. To improve the functional limitation in patients with Temporomandibular Joint Dysfunction.
This study is important because there is limited research comparing the effective of Muscle Energy Technique , Cyriax Technique and Positional Release Techniques in treating Temporomandibular joint pain. Temporomandibular joint problems can significantly impact daily life by causing pain, limiting mobility, and limiting function. This research will help to identify the best treatment approach to improve patient outcomes, especially for Indian populations, and provide valuable evidence for physiotherapists to use effective, non-invasive techniques in their practice.
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