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
|
|
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 Shoulderâ€
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%. |