| CTRI Number |
CTRI/2025/09/094020 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Treatment Program to Reduce Jaw Pain and Improve Jaw Movement in People with Jaw Problems |
|
Scientific Title of Study
|
Effects of a Multimodal Intervention Combining Cranio-Cervicomyofascial Release, Transcutaneous Auricular Vagus Nerve Stimulation, and Exercise on Pain, Oral Function, Oral Health–Related Quality of Life, and Headache in Patients With Temporomandibular Disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Block 4, Room no 105
Kapurthala
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
rameshpatra2208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Block 4, Room no 105
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
rameshpatra2208@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Block 4, Room no 105
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
rameshpatra2208@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University
Jalandhar-Delhi G.T. Road (NH-1), Chaheru, Phagwara District: Kapurthala, Punjab - 144411
India |
|
|
Primary Sponsor
|
| Name |
Lovely Professional University |
| Address |
Block-4, Lovely Professional University |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Chandra Patra |
Lovely Professional University Faculty of Applied Medical Sciences |
Department of Physiotherapy, Faculty of applied medicine Block-4,Room no-105 Lovely Professional University
Kapurthala
PUNJAB |
09653174563
rameshpatra2208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Home based exercise |
Patients in the comparator group will perform home-based range of motion (ROM) exercises similar to those prescribed for the intervention group. They will receive sham transcutaneous auricular vagus nerve stimulation (taVNS) with identical device placement at the auricular cymba conchae, but no electrical current will be delivered. No manual therapy (cranio-cervicomyofascial release) will be administered. The duration and frequency of sham sessions will be matched to those of the intervention group to maintain blinding. |
| Intervention |
Physiotherapy |
Cranio-Cervicomyofascial Release (CCMR):
Gentle manual therapy techniques applied to cranial sutures, cervical spine, and masticatory muscles.
Frequency: 2 sessions per week.
Duration: 20 minutes per session.
Therapist: Licensed physiotherapist trained in CCMR techniques.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS):
Electrical stimulation at the auricular cymba conchae using an FDA-approved taVNS device.
Frequency: 2 sessions per week.
Duration: 20 minutes per session.
Parameters: [Insert stimulation parameters if known, e.g., frequency in Hz, pulse width, intensity range].
Exercise Program:
Daily home-based exercises for jaw mobility, cervical stabilization, and postural correction.
Supervision: Weekly supervised physiotherapy session (1x/week).
Exercise duration: ~20 minutes daily. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with TMD per TMD criteria.
2. Reported pain for more than 3 months.
3. Willingness to attend all treatment sessions. |
|
| ExclusionCriteria |
| Details |
History of major jaw surgery, fractures, or inflammatory joint disease any Neurological disorders contraindicating vagus nerve stimulation and Pregnancy or other medical contraindications. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity |
Baseline, Post, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral function, OHRQoL, OHRQoL, Headache severity/frequency |
Baseline, Post, 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/09/2025 |
| 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="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) affect 5–12% of the population and are a leading cause of chronic orofacial pain, impaired jaw function, and reduced oral health–related quality of life (OHRQoL). TMD is often associated with cervicogenic headache, neck dysfunction, and psychosocial distress, making management complex.
Conservative treatments, including manual therapy, exercise, and behavioral interventions, are recommended as first-line care. However, emerging therapies such as cranio-cervicomyofascial release (CCMR) and transcutaneous auricular vagus nerve stimulation (taVNS) show promise for pain modulation, autonomic regulation, and functional recovery.
To date, no study has examined the combined effects of CCMR, taVNS, and exercise as a multimodal intervention for TMD. This study addresses that gap by testing an integrated approach targeting musculoskeletal, neurological, and functional components of TMD. |