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CTRI Number  CTRI/2021/01/030387 [Registered on: 11/01/2021] Trial Registered Prospectively
Last Modified On: 08/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Impact of Online Physiotherapy to Deliver Physioyoga for Improving the Functional Ability and Pain in the Neck and Shoulder 
Scientific Title of Study   Impact of Telephysiotherapy to Deliver Physioyoga for Improving the Functional Ability and Pain in the Neck and Shoulder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Himani Jodhpura 
Designation  Post Graduate student 
Affiliation  School of Physiotherapy, RK University 
Address  School of Physiotherapy, RK University,Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot , Gujarat- 360020, India.
Musculoskeletal and Sports Department. School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot , Gujarat- 360020, India.
Rajkot
GUJARAT
360020
India 
Phone  7990143051  
Fax    
Email  hjodhpura629@rku.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Priyanshu V Rathod PT PhD 
Designation  Dean, Faculty of Medicine Director, School of Physiotherapy, 
Affiliation  School of Physiotherapy, RK University 
Address  School of Physiotherapy, RK University,Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot , Gujarat- 360020, India.
Musculoskeletal and Sports Department. School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot , Gujarat- 360020, India.
Rajkot
GUJARAT
360020
India 
Phone  9426803108  
Fax    
Email  priyanshu.rathod@rku.ac.in  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Priyanshu V Rathod PT PhD 
Designation  Dean, Faculty of Medicine Director, School of Physiotherapy, 
Affiliation  School of Physiotherapy, RK University 
Address  School of Physiotherapy, RK University,Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot , Gujarat- 360020, India.
Musculoskeletal and Sports Department. School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot , Gujarat- 360020, India.
Rajkot
GUJARAT
360020
India 
Phone  9426803108  
Fax    
Email  priyanshu.rathod@rku.ac.in  
 
Source of Monetary or Material Support  
School of Physiotherapy, RK Universiy 
 
Primary Sponsor  
Name  Ms Himani Jodhpura 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat 360020, India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
School of Physiotherapy RK University  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot - 360020, Gujarat, India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Himani Jodhpura  School of physiotherapy ,RK University Rajkot  Department of Musculoskeletal and Sports School of Physiotherapy RK University Rajkot GUJARAT School of Physiotherapy RK University Kasturba Dham Bhavnagar Highway Rajkot GUJARAT 360020 India
Rajkot
GUJARAT 
7990143051

hjodhpura629@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee ,SPT,RKU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M542||Cervicalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Functional Disability and Pain  Pain by Numerical Pain Rating Scale and Functional disability by Neck Disability Index it will be taken on1st day, endof2nd,3rd,4th week 
Intervention  Telephysiotherapy tO Deliver physioyoga   Online consultation and Delivery of therapeutic exercises to improve Functional ability and Pain at Neck Musculatures. study duration- 3months,Intervation for 4 week sample size -30  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Verbal informed consent by telephone
2. Age between 18 to 65 years
3. Participants able to access internet facilities.
4. Neck Disability Index (NDI) Score - Greater than or equal to 10% and less than or equal to 64 %
5. Participants with non-neurological neck pain

 
 
ExclusionCriteria 
Details  1. Greater than 65 % Neck Disability Index score.
2. History of hospitalization in the last six months
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Neck Disability Index (NDI)  1st Day and End of 1st week,2nd week ,3rd week and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale (NPRS)  1st Day and End of 1st week,2nd week ,3rd week and 4th week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   11/01/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Title- “Impact of Telephysiotherapy to Deliver Physioyoga for Improving the Functional Ability and Pain in the Neck and Shoulder”


Investigators – Ms. Himani Jodhpura BPT, 4th  Sem PostGraduate scholar, Prof. (Dr). Priyanshu Rathod, PT, PhD, Dean, Faculty of Medicine, Director, School of Physiotherapy, RK University, Rajkot 360020, India.


Keyword- Telephysiotherapy, Physioyoga, Functional Ability. Neck and Shoulder 

Material used- Internet and Communication Technology (ICT), Informed consent form, mobile applications to recorded videos of exercise


Introduction - Activities of Daily Livings (ADLs) involves several activities including sit to stand, walking, climbing, grooming, bathing, and many more where every component of human structure matters equally important. Physical inactivities will be one of the major factors to compromise physical activities and lead to functional disability and pain. One of the most common structures that get involved in human mechanics is the Neck and Shoulder. 75% of people in their life span observe neck pain and 85% are non-structural causes of pain and loss of function. Exercises, yoga and lifestyle modification remains the essential part to enhance structural stability and functional mobility. However, in situations where visiting physiotherapy clinics and wellness centers due to pandemics or any challenges in traveling outside the home or workstation, telephysiotherapy observes great scopes in management. Thus, we would like to find out the impact of telephysiotherapy to deliver “physioyoga” for people with neck pain. 


Objective- 1) To assess the impact of Telephysiotherapy in delivering “physioyoga” for pain in Neck musculatures and improve the function. 


Methodology- An interventional study where digital flyers will be circulated on social media to avail telephysiotherapy with “physioyoga” for functional disabilities and pain in the neck and shoulder. Volunteers will be selected based on selection criteria such as Neck Disability Index (NDI) Score - Greater than or equal to 10% and less than or equal to 64 %, Age between 20 to 65 years, and no history of hospitalization in the last six months. Total 4 weeks of telephysiotherapy intervention where volunteers will be redistributed into mild, moderate, and severe groups according to Neck Disability Index Score. Participants will have 2 supervised sessions and 21 non-supervised sessions per week for 4 weeks of intervention and a minimum of 14 sessions per week to be eligible for statistical analysis. Based on the severity and subject-specific Physioyoga will be prescribed to Participants and assessed every week (end of 1st, 2nd, 3rd, and 4th week) for changes in Neck Disability index and Numerical pain rating scale.  


Statistical Analysis -Descriptive and frequency analysis will be done to identify demographic data and homogeneity of the sample. Data distribution will be a key element to decide the statistical tests. Statistical Tests will be used for changes and association within and between the groups for Score Neck Disability Index and Numerical Pain Rating Scale (NPRS). Level of Significance (LOS) will be set to 0.05 and Confidence Interval (CI) at 95%.
 
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