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CTRI Number  CTRI/2024/04/066204 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 19/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   The effect of upper cervical mobilization and fascia massage on pain , range of motion ,endurance of neck muscles and quality of life in patients with head and neck cancer patients taking radiotherapy 
Scientific Title of Study   The effectiveness of upper cervical mobilization and Myofascial release on Pain, Range of motion, Endurance of Deep Neck Flexors and Quality of Life in Head and Neck Cancer participants undergoing radiotherapy: A Pre-Post Experimental 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  Amit Vishnu Mane 
Designation  MPT First year Musculoskeletal sciences 
Affiliation  DVVPFs College of Physiotherapy 
Address  Department of musculoskeletal physiotherapy basement Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar MAHARASHTRA 414111 India Ahmadnagar MAHARASHTRA India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  7720876009  
Fax    
Email  amitvmane003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Amit Vishnu Mane 
Designation  MPT First year Musculoskeletal sciences 
Affiliation  DVVPFs College of Physiotherapy 
Address  Department of musculoskeletal physiotherapy basement Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar MAHARASHTRA 414111 India Ahmadnagar MAHARASHTRA India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  7720876009  
Fax    
Email  amitvmane003@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Anap 
Designation  HOD Musculoskeletal sciences 
Affiliation  DVVPFs College of Physiotherapy 
Address  Department of musculoskeltal physiotherapy basement Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar MAHARASHTRA 414111

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  9890200972  
Fax    
Email  deepak.anap@hotmail.com  
 
Source of Monetary or Material Support  
DVVPFs College of Physiotherapy opp Govt milk dairy MIDC Ahmednagar 
 
Primary Sponsor  
Name  DVVPFs College of Physiotherapy 
Address  Department of musculoskeletal sciences Block 1 basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy MIDC 414111 Ahmadnagar MAHARASHTRA 
Type of Sponsor  Private medical college 
 
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 Amit Mane  D V V P Fs College of Physiotherapy  Vitthalrao vikhe patil memorial hospital Ahmednagar
Ahmadnagar
MAHARASHTRA 		 7720876009

amitvmane003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DVVPFS College of Physiotherapy Institutional ethical Committe Ahmednagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M953||Acquired deformity of neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cervical mobilization, Myofascial release technique  1 )CERVICAL MOBILIZATION For joint mobilization of the neck, Maitlands P-A mobilization will be applied. The subject will be asked to assume a prone position on the treatment bed, and a towel will be placed on their forehead. The therapist will hold the spinous processes of the cervical vertebrae that will be limited in motion or produce pain with both hands, overlap the thumbs of both hands, and apply a Maitland mobilization grade III force from the posterior to the anterior for 30 seconds. This will be given 10 times with a 30-second break between each procedure, and the entire process will be repeated thrice a week for 2 weeks 2) MYOFASCIAL RELEASE TECHNIQUE The patient will be sitting on a chair with back support. The therapist will position herself or himself behind the patient and place her hands over the affected side, i.e., one hand will be placed over the shoulder and the other hand will be placed over the area below the ear of the involved side. MFR will be applied 3–4 times with a 20-second hold. It will be administered thrice a week for 2 weeks.  
Intervention  Craniocervical flexion training , Cervical arom exercises  1)Craniocervical flexion training. The pressure biofeedback unit is centered just below the occiput between the plinth and the back of the neck and inflated to a baseline of 20 mmHg. Each subject is asked to gently and slowly execute the head nodding action at five different levels of pressure (22, 24, 26, 28 and 30 mmHg) and to maintain each level for 10 seconds There is a 30-second rest period between each level. The test protocol ends when the subject is unable to hold the same pressure level for 10 sec or reached a peak level of 30mmHg .A 2-minute rest period will be provided between each level. Sessions will be performed thrice a week for 2 weeks 2.CERVICAL AROM EXERCISES Cervical isometric strengthening exercises •Self stretching (for upper trapezius and levator scapulae) Strengthening exercises (for middle and lower trapezius)) Repeat 10 times/session thrice a week for 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Both males and females participants above 18 years of age

2)Participants undergone surgical treatment for Head and neck cancer

Anterior neck dissection and complete modified neck dissection

3)Tumour, Node , Metastasis (TNM) staging 1-3.

4)Ability to understand and follow instructions

5)No previous participation in similar intervention

6)Participants willing to participate in the study 
 
ExclusionCriteria 
Details  1)Participants with structural instability and osteoporotic changes of cervical spine

2)Any neurological deficits and bone tumors or vertigo

3)History of trauma or fracture in cervical spine 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
pain, range of motion, Endurance, Quality of life  Baseline , 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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)   30/04/2024 
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)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amitvmane003@gmail.com].

  6. For how long will this data be available start date provided 15-01-2026 and end date provided 15-04-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study is to see the  effectiveness of upper cervical mobilization and Myofascial release on Pain, Range of motion, Endurance of Deep Neck Flexors and Quality of Life in Head and Neck Cancer participants undergoing radiotherapy: A Pre-Post Experimental study .Total 43 partcipants will be recruited based on inclusion and exclusion criteria.Total treatment protocol will be of 2 weeks .Intervention should be given for thrice a week upto 2 weeks. Data will be analyzed stastistically 
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