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CTRI Number  CTRI/2025/10/096152 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of muscle energy technique for jaw mobility in head and neck cancer survivors.  
Scientific Title of Study   Effect of muscle energy technique on trismus and quality of life in head and neck cancer survivors: 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 Sayali N Patil 
Designation  Associate professor, Department of oncology physiotherapy 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center, Department of Oncology Physiotherapy, OPD number 39,Sagar floor, Belagavi, Karnataka-590010, India

Belgaum
KARNATAKA
590010
India 
Phone  8793713489  
Fax    
Email  sayalipatil@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sayali N Patil 
Designation  Associate professor, Department of oncology physiotherapy 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center, Department of Oncology Physiotherapy, OPD number 39,Sagar floor, Belagavi, Karnataka-590010, India

Belgaum
KARNATAKA
590010
India 
Phone  8793713489  
Fax    
Email  sayalipatil@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Valanka Diana Cardozo 
Designation  Intern 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center, Department of Oncology Physiotherapy, OPD number 39,Sagar floor, Belagavi, Karnataka-590010, India

Belgaum
KARNATAKA
590010
India 
Phone  8600298478  
Fax    
Email  valanka201220@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr. Prabhakar Kore hospital and research center, Nehru Nagar, Belagavi 
 
Primary Sponsor  
Name  KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi-590010 
Type of Sponsor  Research institution and hospital 
 
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 Sayali N Patil  KAHER Institute of Physiotherapy  Advanced Physiotherapy center, OPD number 39, sagar floor, Department of Oncology Physiotherapy, Belagavi Karnataka-590010 India
Belgaum
KARNATAKA 		 8793713489

sayalipatil@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC KLE ACADEMY OF HIGHER EDUCATION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Muscle Energy Technique   MET 2 - Post isometric relaxation. Patients seated, with practitioners thumb on upper molar. Patients performs gentle isometrics (mouth closing) against practitioners counter pressure. Hold 7-10 seconds, relax, take to a new barrier, repeat 2-3 times. Weekly 4 times every alternate day for a total of 10 sessions.  
Intervention  Muscle Energy Technique   Muscle Energy Technique will be given for 10 days on head and neck cancer survivors having trismus. MET 1 - Reciprocal Inhibition Patient seated , elbow on table, chin in hand. Patient attempts mouth opening against resistance for 10 seconds and relax. Take jaw to new barrier. Repeat 2-3 times per day. Weekly 4 times every alternate day for 10 sessions  
Comparator Agent  Standard usual care  Submaximal effort (about 30-50 percent of maximal contraction) done in pain-free range. Active and functional facial exercises. Jaw, Posture and Breathing exercises. Chin tucks. Deep diaphragmatic breathing. Cheek puff and suck- in. Smile (closed and open mouth) Lip protrusion. Jaw opening and closing. lateral excursion. Tongue mobility exercises. Neck strengthening exercises. Hold each exercise for 5-10 seconds. Rest 5 seconds between reps. Each session will be 10-15 minutes. 2-3 Times per day.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Head and neck cancer survivors having inter-incisor distance less than 40mm
Restricted jaw movement
Patient with ECOG less than 2
All genders within the age group of 30-70 years 
 
ExclusionCriteria 
Details  Fracture of the jaw or TMJ
Healing flap
Infection around jaw
Active cancer intra-oral and extra-oral region
Presence of tracheostomy tube
Active wounds around the jaw 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Maximal mouth opening (MMO)
Oral health related quality of life (OHRQOL) 		 Baseline, post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Jaw functional limitation scale (JFLS)  Baseline, post treatment 
Functional impairment Glasgow scale (FIGS)  Baseline, post treatment 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   Phase 2 
Date of First Enrollment (India)   01/11/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Head and neck cancer is one of the most common cancers globally and in India, with treatments like surgery, radiation, and chemotherapy often leading to long-term functional complications.

MET is a manual therapy method used to treat shortened or weak muscles, restricted joints, and lymphatic issues by using controlled muscle contractions to mobilize tissues and joints.

It functions as both a treatment and diagnostic technique for motion restrictions, though current literature calls for evidence-based validation and refinement of its concepts.

MET, particularly hold–relax  techniques, can improve the functional mobility of the temporomandibular joint (TMJ) and increase mouth opening, but research on its effectiveness for TMJ dysfunction is limited.

After Modified Radical Neck Dissection (MRND), patients often experience pain, tightness, and reduced shoulder and neck mobility, emphasizing the need for structured rehabilitation to improve function and quality of life.

While MET has been studied for neck and shoulder dysfunctions, there is minimal research on its role in TMJ and intraoral dysfunctions among head and neck cancer survivors highlighting the need for this study.

 

 
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