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CTRI Number  CTRI/2022/11/046983 [Registered on: 02/11/2022] Trial Registered Prospectively
Last Modified On: 07/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To find the effect between kinesio-taping and old school physiotherapy to reduce pain in knee osteoarthritis patients hamstring tightness and functional disability in Knee Osteoarthritis Participants  
Scientific Title of Study   Effects of kinesio taping over conventional physiotherapy exercise on pain,hamstring tightness and functional disability in knee osteoarthritis participants-a randomised controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NIKITA R RATHOD 
Designation  PG STUDENT 
Affiliation  VENUS INSTITUTE OF PHYSIOTHERAPY-SWARNNIM START UP AND INNOVATION UNIVERSITY 
Address  POST BHOYAN ROAD,NR. ONGC WSS, OPP. IFFC KALOL HIGHWAY, BHOYAN RATHOD GANDHINAGAR

Gandhinagar
GUJARAT
382420
India 
Phone  9426622442  
Fax    
Email  nikira9911@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ARVIND KUMAR 
Designation  PRINCIPAL, PROFESSOR, PG GUIDE 
Affiliation  VENUS INSTITUTE OF PHYSIOTHERAPY-SWARRNIM START UP AND INNOVATION UNIVERSITY 
Address  POST BHOYAN ROAD,NR. ONGC WSS, OPP. IFFC KALOL HIGHWAY, BHOYAN RATHOD GANDHINAGAR

Gandhinagar
GUJARAT
382420
India 
Phone  9784631151  
Fax    
Email  principal.physio@swarrnim.edu.in  
 
Details of Contact Person
Public Query  
Name  DR ARVIND KUMAR 
Designation  PRINCIPAL, PROFESSOR, PG GUIDE 
Affiliation  VENUS INSTITUTE OF PHYSIOTHERAPY-SWARRNIM START UP AND INNOVATION UNIVERSITY 
Address  POST BHOYAN ROAD,NR. ONGC WSS, OPP. IFFC KALOL HIGHWAY, BHOYAN RATHOD GANDHINAGAR

Gandhinagar
GUJARAT
382420
India 
Phone  9784631151  
Fax    
Email  principal.physio@swarrnim.edu.in  
 
Source of Monetary or Material Support  
Venus institute of Physiotherapy-Swarrnim Startup & Innovation University 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
NIKITA R RATHOD  Outdoor Patient Department Venus Institute of Physiotherapy  Post Bhoyan Rathod ,Nr.ONGC WSS, opp. IFFCO Adalaj-Kalol highway Bhoyan Rathod
Gandhinagar
GUJARAT 		 9426622442

nikira9911@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-VENUS INSTITUTE OF PHYSIOTHERAPY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONVENTIONAL PHYSIOTHERAPY  Isometric Exercises for quadricepS Straight leg raising Hip abductors strengthening the last degree knee exercise training The progression was done when patient was eased to do exercises either by increasing repetition or frequency of exercises. Self-Hamstring stretching Frequency : 3 sessions in a week on alternate days Duration : 30 minutes per session for 3 weeks 
Intervention  Home Advice  Use hot/cold packs Do not sit on floor Do not stand/sit for longer duration Do not squat Wear comfortable footwear Wear knee caps  
Comparator Agent  KINESIOTAPING AND CONVENTIONAL PHYSIOTHERAPY  The Kinesio tape was applied with approximately 40% stretch of its maximal length on the Hamstring group muscles based on the principle of activation technique. Here the direction of taping was applied origin to insertion of the muscles. Taping protocol was designed based on the principle of activation technique. Kinesio-tape was applied on the hamstring muscles Also, according to Kase Wallis principles of KT, a gap of at least 30 min was given after the tape application to achieve a complete activation of the glue, which is believed to improve the performance of the kinesio-tape on the quadriceps muscle. 3 therapy sessions per week [working alternative days], for total 3 weeks. After applied KT, all the OA knee study participants were undergone supervised conventional physiotherapy i.e Isometric Exercises for quadriceps, Straight leg raising, Hip abductors strengthening, the last degree knee exercise training,The progression was done when patient was eased to do exercises either by increasing repetition or frequency of exercises, Self-Hamstring stretching Frequency : 3 sessions in a week for total 3 weeks 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  OA with pain at least in one knee for more than 2 months.
Pain intensity level between 4- 8 point of NPRS.
Participants that can walk independently.
Radiographic evidence or any prior medical diagnosis by a professional 
 
ExclusionCriteria 
Details  Any acute inflammation, contracture or surgery affecting the knee.
Pain during exercise or unstable medical conditions.
Patient that had NSAIDS injection few months back.
Any skin allergy, local skin lesion and infection.
Any allergic reaction after the treatment of Kinesiotherapy.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Modified Western Ontario and McMaster Universities Index  Pre and post treatement(after 3 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
NPRS  Pre and post treatment(after 3 weeks) 
Active knee extension test  Pre and post treatment(after 3 weeks) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/11/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 26/11/2022 
Estimated Duration of Trial   Years="0"
Months="0"
Days="21" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Osteoarthritis is a one of the major chronic joint disease worldwide. Cartilage is the central tissue affected by OA and causes subsequent symptoms, including joint pain, stiffness and joint swelling, which diminishes the range of motion. 30 Osteoarthritis participants will be randomly selected for the study from different physiotherapy OPDs of Rajkot. The participants will randomly divided into two groups: Experimental Group N= 15 and Conventional Group N=15. The Experimental group will receive Kinesiotaping and Conventional physiotherapy for 3 weeks and the Conventional group will receive the conventional physiotherapy protocol for 3 weeks. The Pre and Post treatment scores of NPRS, mWOMAC and Active knee extension test will be measured.The aim of this study to determine the effectiveness of additional Kinesio-taping (KT) with the conventional physiotherapy on pain, Hamstring tightness and functional disability in knee osteoarthritis participants The hypothesis of this study is there will be no difference in kinesio-taping over conventional physiotherapy exercises on pain, Hamstring tightness and knee functional disability in knee osteoarthritis participants. Experimental Hypothesis will be a significant difference in kinesio-taping over conventional physiotherapy exercises on pain, Hamstring tightness and knee functional disability in knee osteoarthritis participants 
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