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CTRI Number  CTRI/2024/03/063497 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 17/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of Matrix Rhythm Therapy in reduced mouth opening in people who have tobacco. 
Scientific Title of Study   Efficacy of Matrix Rhythm Therapy in Trismus among Smokeless Tobacco Users: A pilot 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  Varun Naik 
Designation  Associate Professor 
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KAHER Institute of Physiotherapy Department of Cardiovascular thoracic Surgery room no 39 Nehru Nagar Belagavi, Karnataka
KAHER Institute of Physiotherapy Department of Cardiovascular thoracic Surgery room no 39 Nehru Nagar Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  9986497065  
Fax    
Email  varunnaik@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Varun Naik 
Designation  Associate professor  
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KAHER Institute of Physiotherapy Department of cardiovascular Thoracic Surgery room no 39 Nehru Nagar Belagavi, Karnataka
KAHER Institute of Physiotherapy Department of cardiovascular Thoracic Surgery room no 39 Nehru Nagar Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  9986497065  
Fax    
Email  varunnaik@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Reena Naik 
Designation  Intern 
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KAHER Institute of Physiotherapy Nehru Nagar Belagavi, Karnataka
KAHER Institute of Physiotherapy Nehru Nagar Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  8390374982  
Fax    
Email  reenanaik61@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  KLe Academy of Higher Education and Research 
Address  JNMC campus, Nehru Nagar, belgaum, 590010 
Type of Sponsor  Private hospital/clinic 
 
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 Varun Naik  KLE DR Prabhakar kore hospital  department of Cardiovascular and thoracic surgery physiotherapy,Nehru nagar JNMC Belgavi
Belgaum
KARNATAKA 		 9986497065

varunnaik@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  restricted mouth opening 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  matrix rhythm therapy  it will consist of application of matrix rhythm therapy.2 sessions per week for 1 week 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
1)participants within age group 19-65 years
2)mouth opening limited to or less than 35mm
3) smokeless tobacco or areca nut chewer for more than 10 years 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1)Active infection
2)Patients diagnosed with Head and neck cancer
3)Unwilling participant
4)Contraindications of Matrix Rhythm Therapy:Open, inflamed or infected skin surfaces
-Fresh fractures
-Tendency for bleeding, hematoma formation
-Tendency towards embolism
-Pacemaker
-Mucous membranes
-Direct contact to bones 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Maximal intraincisal opening   1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analogue scale  for assessment of variation in intensity of pain 
Gothenburg Trismus Questionnaire  1 week 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   08/01/2025 
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 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  

Efficacy Of Matrix Rhythm Therapy in Trismus Among Smokeless Tobacco Chewers- A Pilot study

 

Inclusion Criteria:

All genders.

•Ages between 19-65 years.

•Mouth opening limited to or less than 35mm

•Smokeless tobacco/ areca nut (betel nut) chewers for more than 10 years.

 

Exclusion Criteria:

•Active infection

•Patients diagnosed with Head and neck cancer

•Unwilling participant

•Contraindications of Matrix Rhythm Therapy

-Open, inflamed or infected skin surfaces

-Fresh fractures

-Tendency for bleeding, hematoma formation

-Tendency towards embolism

-Pacemaker

-Mucous membranes

-Direct contact to bones

 

METHODOLOGY:

•       Source of data: Community

•       Study design: Experimental

•       Duration of data collection: 3 months

•       Duration of study: 6 months

•       Place of study: Belagavi city

•       Target population: Smokeless tobacco consumers for more than 10 years

•       Sampling design: Non- Probability sampling

•       Sampling technique: convenience

Sampling size: 12

OUTCOME MEASURES:

1)Mouth opening: Maximal intraincisal opening (MIO)

2)Pain assessment: Visual Analogue Scale (VAS)

3)Quality of life and screening tool: Gothenburg Trismus Questionnaire

PROCEDURE

•      patients will be screened and then recruited as per the inclusion and exclusion criteria.

•     Participants will be briefed about the purpose of the study.

•     A written inform consent will be given to the participants in their own language and those consenting to participate in the study will be presented with the interventions.

•     Brief demographic data will be obtained from each participant prior to the assessment.

•     Pre-intervention:

•     MIO will be measured pretreatment using vernier caliper.

•     Pain will be evaluated using Visual Analogue Scale.

•     Outcome measures such as Gothenburg Trismus questionnaire, will be filled by the patients

•     The participants will be made to lie down comfortably in a supine position.

•     The area that will be treated are the muscles of the lower face and the anterior neck.

•     These areas will be well exposed and talcum powder will be applied over the treatment area to avoid the friction caused by the Matrix Mobil®

•     The application of Matrix Mobil will be given in a longitudinal stroking manner by pushing the probe of the device into the muscles of anterior and posterior neck, and entire face. The duration of every session will be 60 minutes for every subject.

•     Following two sessions of treatment with Matrix Rhythm Therapy, the Maximal interincisal opening and pain on VAS will be evaluated again, and any difference if present will be noted.

•     12 subjects will be receiving two sessions of MRT each.

•     Number of sessions: two sessions per week 

•     Duration: 60 mins

 


 
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