| CTRI Number |
CTRI/2026/01/100435 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of neck and jaw exercises on jaw pain and movement |
|
Scientific Title of Study
|
Effectiveness of Neck Motor Control with Jaw Exercises on Pain,Temporomandibular Range of Motion ,Jaw Function and Oral
Health-Related Quality of Life in Patients with Chronic Temporomandibular Joint Disorder : A Randomized Controlled 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 |
Dr Krina Kalpesh Shah |
| Designation |
PG student |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Musculoskeletal Physiotherapy Tilak Maharastra Vidyapeeth J block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930775845 |
| Fax |
|
| Email |
krinasphysio1924@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Danish Shaikh |
| Designation |
Assistant professor |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Musculoskeletal Physiotherapy Tilak Maharastra Vidyapeeth J block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7276064395 |
| Fax |
|
| Email |
dn.shaikh09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Danish Shaikh |
| Designation |
Assistant professor |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Musculoskeletal Physiotherapy Tilak Maharastra Vidyapeeth J block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7276064395 |
| Fax |
|
| Email |
dn.shaikh09@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Musculoskeletal Physiotherapy Tilak Maharastra Vidyapeeth J block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Musculoskeletal Physiotherapy Tilak Maharastra Vidyapeeth J block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Krina Shah |
TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Musculoskeletal Physiotherapy Tilak Maharastra Vidyapeeth J block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA |
9930775845
krinasphysio1924@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional Ethics Committee Academics |
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 |
Control group |
Participants will receive only manual therapy for TMJ and cervical spine including TMJ mobilization, myofascial release of masticatory and cervical muscles, cervical PA/lateral glides, and stretching.Dosage & Duration: 30 minutes per session, 3 sessions/week for 4 weeks (total 12 sessions). |
| Intervention |
Experimental group |
Participants will receive neck motor control training focusing on deep cervical flexor and extensor activation combined with manual therapy techniques for the TMJ and cervical spine (TMJ mobilization, myofascial release, cervical PA and lateral glides, and stretching).Dosage & Duration: 40–45 minutes per session, 3 sessions/week for 4 weeks (total 12 sessions) |
| Intervention |
Study group |
Participants will receive combined neck motor control training and structured jaw exercise program tongue position training, free jaw movements, resisted mandibular movements along with manual therapy for TMJ and cervical region. Dosage & Duration 50 to 60 minutes per session 3 sessions per week for 4 weeks with a total 12 sessions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 to 60 years
2. Male and female
3. Diagnosed chronic temporomandibular joint disorder TMD symptoms present for more than 3 months
4. Diagnosis of Mixed TMD or Masticatory myofascial pain TMD as per dental OPD diagnosis Helkimo index for clinical research
5. Pain intensity more than or equal to 3 on Visual Analogue Scale VAS NRS at baseline |
|
| ExclusionCriteria |
| Details |
1. History of systemic rheumatologic or connective tissue disease eg rheumatoid arthritis fibromyalgia
2. History of neck or facial trauma
3. Past surgical history of the cervical spine or craniofacial surgery
4. Current mental illness that would interfere with participation consent
5. Any diagnosed tumour in the head neck oral region
6. Active oral infections or recent dental procedures that may confound outcomes
7. Current use of occlusal splints or physiotherapy treatment within the past 6 months |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pain intensity
2) Jaw function |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Temporomandibular joint range of motion
2) Oral Health related Quality of life |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
12/01/2026 |
| 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="6"
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 study is a randomized controlled trial designed to evaluate the effectiveness of neck motor control training combined with jaw exercises on pain temporomandibular joint range of motion jaw function and oral health related quality of life in individuals with chronic temporomandibular disorders TMD A total of 84 participants aged 18 to 60 years with chronic TMD will be recruited and randomly allocated into three parallel groups Group A will receive neck motor control training with manual therapy Group B will receive neck motor control training combined with jaw exercises along with manual therapy and Group C will receive manual therapy alone Interventions will be administered three times per week for four weeks Primary outcomes include pain intensity and jaw function Secondary outcomes include temporomandibular joint range of motion and oral health related quality of life Outcome assessments will be conducted at baseline post-intervention 4 weeks and at 1 month and 3 month follow-up The study aims to determine whether the combined neck and jaw exercise approach provides superior clinical benefits compared to neck motor control training alone and manual therapy in patients with chronic TMD |