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CTRI Number  CTRI/2024/02/062802 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Exploring the Impact of kinesio Taping versus Foam Rolling on Iliotibial Band Syndrome in Long-Distance Runners. 
Scientific Title of Study   Comparative Effect of Kinesio Taping and Foam Rolling in Iliotibial Band Syndrome in long distance runners. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Noor Alam 
Designation  PG Scholer 
Affiliation  Amity institute of health allied science 
Address  Room no.03 Lower Ground Floor, F1, Amity institute of health allied science, Amity university Noida , sec 125 Noida Uttar Pradesh India 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9045443718  
Fax    
Email  nooralamkhan1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rabab Kaur 
Designation  Assistant Professor 
Affiliation  Amity institute of health allied science 
Address  Room no:23,Lower Ground Floor,F01,Amity Institute of Health Allied Sciences,Amity University Sec 125 Noida Uttar Pradesh India 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9654478155  
Fax    
Email  rkaur4@amity.edu  
 
Details of Contact Person
Public Query  
Name  Dr Rabab Kaur 
Designation  Assistant Professor 
Affiliation  Amity institute of health allied science 
Address  F1, LGF 23,Amity Institute of Health Allied Sciences,Amity university, Sec 125 Noida Uttar Pradesh India 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9654478155  
Fax    
Email  rkaur4@amity.edu  
 
Source of Monetary or Material Support  
Dr. Vimals physiotherapy & sports injury clinic , Room no;01,Lower Ground Floor A-20 August Kranti Marg, Block A, Gulmohar Park, New Delhi, Delhi 110049 
 
Primary Sponsor  
Name  Noor Alam 
Address  Amity Institute of health allied science, Amity University Noida Uttar Pradesh India 201301  
Type of Sponsor  Other [SELF] 
 
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 Noor Alam   Dr. Vimals physiotherapy & sports injury clinic  A-20, Room no:01 lower gound floor,20 August Kranti Marg, Block A, Gulmohar Park, New Delhi, Delhi 110049
South
DELHI 		 9045443718

nooralamkhan1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Dr. Vimals physiotherapy & sports injury clinic  No Objection Certificate 
Institutional NTCC Committee Amity Institute of Health Allied Sciences. Amity University Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M763||Iliotibial band syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Tretment  Ultrasonic technique Patients lie on the side with good pillow support and good comfort Set intensity to zero Turn knob to continuous Apply ultrasound gel over treatment head Place ultrasound gel over treatment area Rotate treatment head (3 MHz) with one handset intensity knob to continuous Increase intensity to 1.5 watts per cm2 Continue for 8 minutes. 
Intervention  Kinesio taping and foam rolling  Kinesio tape was applied to the IT band and lateral thigh muscles. • The tape was applied in a fan-like pattern, with the ends of the tape extending approximately 1 inch beyond the proximal and distal ends of the IT band. • The tape was applied with 20-30% tension. • The tape was worn for 3-7 days at a time and was replaced every 3-7 days. Foam rolling was performed for 5 minutes per day, targeting the IT band, quadriceps, hamstrings, and glutes. • The foam roller was used to apply moderate pressure to the muscles, rolling back and forth for 30-60 seconds per muscle group. • Foam rolling was performed before and after the CT exercises. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  Male long-distance Runners.
Between the ages of 20 to 30.
Chronic IT band syndrome. 
 
ExclusionCriteria 
Details  recent operation.
Unhealed fractures in the lower limbs neurological conditions.
bone illnesses 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
pain  4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
strength,flexibility  4 weeks. 
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   26/02/2024 
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="0"
Months="4"
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  

The study is a Randomized Controlled Trial (RCT) conducted at Dr. Vimal Physiotherapy and Sports Injury Clinic, focusing on male long-distance runners aged 20 to 30 with chronic IT band syndrome. The study employs convenience sampling with a sample size of 107 athletes, divided into three groups: Group A (Foam roller exercise with Conventional therapy), Group B (Iliotibial band Conventional therapy), and Group C (Kinesio Taping with Conventional therapy).

The inclusion criteria involve male long-distance runners with chronic IT band syndrome, while exclusion criteria include recent operations, ligament damage, unhealed fractures, neurological conditions, and bone illnesses.

The dependent variables measured are pain, strength, and flexibility, while the independent variables are Kinesio taping, foam roller exercises, and stretching. The tools used for assessment include the Quadruple Visual Analogue Scale (QVAS), Modified Cincinnati Rating System Questionnaire (MCRSQ), and Lower Extremity Function Scale (LEFS).

The study procedure involves obtaining clearance from the Research Committee and Ethical Committee, conducting interviews to establish eligibility, obtaining informed consent, and administering pre-testing questionnaires. After the 4-week intervention, participants will fill out questionnaires again, and parameters will be reassessed for analysis and comparison.

Doseometry for each group is outlined, including the application of Kinesio tape, foam rolling, and conventional therapy. The conventional therapy program consists of ultrasound (US) therapy, stretching, and strengthening exercises for hip and knee muscles.

The ultrasound technique involves using a supportive pillow, comfortable position, and applying ultrasound gel over the treatment area for 8 minutes.

Stretches and strengthening exercises are specified for each group, focusing on IT band, hamstring, quadriceps, hip abductor, hip extensor, and knee extension exercises.

The study aims to determine the effectiveness of different interventions in managing chronic IT band syndrome in long-distance runners, with the results to be analyzed and compared after the 4-week program.

 
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