| CTRI Number |
CTRI/2025/12/099815 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Analytical Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of jaw joint function in individuals with and without neck pain |
|
Scientific Title of Study
|
Function of temporomandibular joint in patients with mechanical cervical pain and matched controls: An observational analytical study |
| 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 Swati Paranjape |
| Designation |
Professor Additional |
| Affiliation |
Seth G S medical College, KEM Hospital |
| Address |
Physiotherapy Department, Seth G S Medical College, Parel,
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107000 |
| Fax |
|
| Email |
swati.paranjape@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meghana Maddi |
| Designation |
Post Graduate Student |
| Affiliation |
Seth G S medical College, KEM Hospital |
| Address |
Physiotherapy Department, Seth G S Medical College, Parel,
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107000 |
| Fax |
|
| Email |
maddimeghana31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghana Maddi |
| Designation |
Post Graduate Student |
| Affiliation |
Seth G S medical College, KEM Hospital |
| Address |
Physiotherapy Department, Seth G S Medical College, Parel,
Mumbai
MAHARASHTRA
400012
India
Physiotherapy Department, Seth G S Medical College, Parel,
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107000 |
| Fax |
|
| Email |
maddimeghana31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy Department, Seth G S Medical College, Parel,
Mumbai
MAHARASHTRA
400012
India |
|
|
Primary Sponsor
|
| Name |
Seth G S Medical College |
| Address |
Seth G S Medical College, Parel, Mumbai, 400012 |
| Type of Sponsor |
Government medical college |
|
|
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 Meghana Maddi |
KEM hospital |
OPD Number 402, KEM Orthopedic Center, Opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA |
02224107000
maddimeghana31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC-II) Relating to Biomedical and Health Research (BHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with and without neck pain. 2. Both males and females. 3. Patients with neck pain from C3 vertebral level to C7 vertebral level in Study group. 4. Neck pain present for more than 3 months in study group. 5. Pain intensity from 3 to 7 as per visual analogue scale in study group. |
|
| ExclusionCriteria |
| Details |
1. Patients with non mechanical cause of neck pain in study group and individuals with neck pain in control group 2.Presence of any inflammatory rheumatic diseases like ankylosing spondylitis and rheumatoid arthritis. 3. Any congenital or acquired musculoskeletal disorders like scoliosis, Klippel Feil syndrome, etc. 4. Presence of any sensory motor, neurological conditions. 5. Primary TMJ dysfunctions in the past 6. History of any TMJ surgery. 7. History of any nicotine consumption in any form or substance abuse. 8. Presence of any sero-negative autoimmune disorders like systemic lupus erythematous, psoriatic arthritis, etc. 9.Presently having any maxillo-oro-facial conditions causing pain like wisdom tooth, cavities, etc. 10. History of any dental procedure in last 6 months. 11. Presence of any dental implants. 12. Auditory and visual impairments without corrections. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
TMJ FUNCTION: It is assesed using Helkimo Clinical Dysfunction Index
HEAD POSTURE: It is assesed for severity of Forward Head Posture using Photogrammetry method. Craniovertebral Angle is calculated using Photogrammetry method.
NECK PAIN INTENSITY: Neck pain intensity is measured using Visual Analogue Scale (VAS)
|
Once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIl |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2026 |
| 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="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
|
The connection between body parts creates a sense of wholeness. The entire rib cage and the cranio-maxillofacial complex share a same membrane origin. Earlier the temporomandibular joint (TMJ) was not considered as a load bearing joint therefore, the function of this joint was not considered as important. However, the dysfunction of this joint results in pain and limitations of some of the most vital activities of daily living such as communication and food consumption. Several studies reported the possible involvement of cervical spine in patients with temporomandibular dysfunction. However, the evidence examining the reverse that is, involvement of TMJ in mechanical cervical pain is limited. Research suggests that forward posture may lead to neck pain and decreased cervical spine extension. With increased screen usage and prolonged use of altered spinal postures at work and in educational facilities, the prevalence of neck pain is increasing. Therefore, it becomes important to study the difference in TMJ function between patients with neck pain and individuals without neck pain. There is contradictory evidence which establish the correlation between head posture and TMD. Hence, the study titled “Comparison of temporomandibular joint function in patients with neck pain and matched controls” is designed. 15 participants having chronic mechanical neck pain and 15 matched controls will be included in the study. Participants will be recruited by purposive sampling method and according to the inclusion and exclusion criteria. The participants will be assessed using Helkimo clinical dysfunction index and cranio-vertebral angle. Descriptive analysis of the data will be performed by comparing mean values of Helkimo Index between individuals with neck pain and those without neck pain using appropriate parametric or non-parametric tests depending on data normality. The study will also analyze the odds of finding altered temporo-mandibular joint function in those exposed to neck pain. |