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CTRI Number  CTRI/2022/12/048413 [Registered on: 23/12/2022] Trial Registered Prospectively
Last Modified On: 03/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Masticatory muscle energy technique exercises Versus Rocabado Exercises in Temporomandibular joint dysfunction  
Scientific Title of Study   Comparison of Masticatory Muscle Energy Technique versus Rocabado exercises for Temporomandibular Dysfunction in Chronic Neck Pain Patients.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhavi Santosh Doke 
Designation  Associate Professor 
Affiliation  Terna Physiotherapy College 
Address  Terna Physiotherapy college,3rd floor, Terna Medical College Campus, Sector 12, near Sarsole Bus Depot, Phase II, Nerul West, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  09869657483  
Fax    
Email  madhavilokhande@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Rajashree V Naik 
Designation  Professor 
Affiliation  Physiotherapy Dept, Lokmanya Tilak Municipal Medical College, Sion.  
Address  Lokmanya Tilak Municipal Medical College & General Hospital, Dr. Ambedkar Road, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone    
Fax    
Email  rajvinaik@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Madhavi Santosh Doke 
Designation  Associate Professor 
Affiliation  Terna Physiotherapy College 
Address  Terna medical college campus,3rd floor, near sarsole bus depot, sector 12, Nerul west, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  09869657483  
Fax    
Email  madhavilokhande@gmail.com  
 
Source of Monetary or Material Support  
Terna Physiotherapy college, Terna Specialty Hospital and Research Center  
 
Primary Sponsor  
Name  Madhavi S. Doke 
Address  Terna Physiotherapy college,3rd floor, Terna Medical College Campus, Sector 12, near Sarsole Bus Depot, Phase II, Nerul West, Navi Mumbai, Maharashtra 400706 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhavi Doke  Terna Hospital and Research Center  Physiotherapy musculoskeletal OPD- 111 and 117, Nerul west Navi Mumbai
Thane
MAHARASHTRA 		 09869657483

madhavilokhande@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Masticatory MET technique  masticatory MET technique to masticatory muscles will be given 3 times a week for 4 weeks (12 exercise sessions). Rocabados Exercises will be given 3 times a week for 4 weeks (12 exercise sessions). The control group will receive neck exercises 3times a week for 4weeks. MET treatment, involving an isometric contraction in which the patient attempts to close the mouth against resistance. Following this procedure, the patient would be encouraged to gently stretch the muscles by opening the mouth widely. This can be assisted by the practitioner. To relax the short tight muscles using post-isometric relaxation, counter-pressure would be required in order to prevent the open jaw from closing (using minimal force). This would require the thumbs (suitably protected) to be placed along the superior surface of the lower back teeth while an isometric contraction was performed by the patient. In this exercise, the practitioner is directing force through the barrier (practitioner-direct method) rather than the patient.  
Comparator Agent  Neck exercises  neck mobility- neck extension, lateral flexion, rotations will be given 10 repetitions once a day and short neck flexor strengthening exercises -chin tucks 10 rep, 3sets once a day for 4 weeks will be given.  
Intervention  Rocabados Exercises  The second intervention includes Rocabado’s exercise which consists of 6 exercises. The exercise program addresses the postural relationship with the head to neck, neck to shoulders, and lower jaw to upper jaw. Rocabado advocates the instruction of 6 functional components of activity, each exercise for 6 repetitions, 6 times a day, 6 days a week 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Phase1-Subjects from both genders with neck pain felt posteriorly between the inferior margin of occiput and T1 with a duration of more than two months with Numerical Rating Scale (NRS) score for pain from 3 to 7.
Phase2-Patient who have positive TMD dysfunction on HCDI ( Helkimo clinical dysfunction index)and FAI ( Fonseca’s anamnestic index) with chronic neck pain in the age group of 20 to 50 years. 
 
ExclusionCriteria 
Details  Subjects with history of cervical or facial trauma or surgery, diagnoses of cervical myelopathy, congenital or acquired anomalies involving the spine and pelvis such as scoliosis, any systemic arthritis, recurrent middle ear infections over the last 5 years or any hearing impairment requiring the use of a hearing aid, patients with vestibular dysfunction, such as vertigo, any disorder of the central nervous system and pregnancy or breast-feeding will be excluded from this study. Subjects have/had dental/orthodontic treatment within the past seven days. Head loaders and Mathadi workers with severe neck pain. Chronic tobacco chewer and smoker. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Jaw functional limitation scale and ROM of the jaw (MMO), Neck disability index, Cervical Posture angles, Cervical ROM, Neck flexor endurance, PHQ-9 , GAD-7   Assessment will be done at the beginning of the study period and will repeat on the 2nd week and last day of the study period. 
 
Secondary Outcome  
Outcome  TimePoints 
PHQ-9, GAD-7  2years 
 
Target Sample Size   Total Sample Size="421"
Sample Size from India="421" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="162" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/12/2022 
Date of Study Completion (India) 20/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/08/2025 
Estimated Duration of Trial   Years="3"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Temporomandibular disorders (TMD) consist of a group of disorders affecting the temporomandibular joint (TMJ), the masticatory muscles, or both. TMD is a major public health problem affecting a significant part of the population.

Chronic neck pain patients develop changes in craniofacial muscles over the years which can remain asymptomatic till the provoking factor appears.

According to the previous studies from India on prevalence, there are many asymptomatic individuals with TMD.  The burden on health care will reduce If we target those people before they become symptomatic. In this study, we want to find the prevalence of TMD in chronic neck pain patients as there are no studies available in India where TMD prevalence has been found in chronic neck pain patients. According to the literature a multidisciplinary or interdisciplinary treatment approach is recommended for better results and improvement in patients with musculoskeletal disorders, especially TMD and neck disorders which have multifactorial etiologies.

In phase two, we want to compare two techniques. The Masticatory Muscle energy technique is one of the soft tissue mobilization techniques, which targets the muscles of mastication such as temporalis, masseter, lateral, and medial pterygoid.

The second intervention includes Rocabado’s exercise which consists of an exercise program that addresses the postural relationship with the head to neck, neck to shoulders, and lower jaw to upper jaw. There is a paucity of literature on the effectiveness of Rocabados exercises. The effect of MET and Rocabados exercises was compared with other interventions but there are no studies where MET and Rocabados exercises are compared. Hence in this study, these two interventions will be compared to see their effectiveness on Neck and TMJ dysfunction. 
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