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CTRI Number  CTRI/2025/11/097043 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 06/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Improving running performance and reducing pain through core strengthening  
Scientific Title of Study   Effect Of Core Strengthening On Pain And Functional Mobility In Recreational Runners With Iliotibial Band Syndrome An 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  Dr Vinuta Harpanhalli 
Designation  Associate Professor of Geriatric Physiotherapy 
Affiliation  KAHER Institute of Physiotherapy 
Address  KLE DR Prabhakar Kore Hospital and MRC Advanced Physiotherapy center department of Geriatric physiotherapy room no 20 sagar floor Belgavi Karnataka 590010 Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9714334270  
Fax    
Email  vinutaharpanhalli@kle.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Mamata Mahaveer Tharkar 
Designation  student 
Affiliation  KAHER Institute of Physiotherapy 
Address  KLE DR Prabhakar Kore Hospital and MRC Advanced Physiotherapy center department of Geriatric physiotherapy room no 20 sagar floor Belgavi Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  8766472578  
Fax    
Email  mamatatharkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mamata Mahaveer Tharkar 
Designation  student 
Affiliation  KAHER Institute of Physiotherapy 
Address  KLE DR Prabhakar Kore Hospital and MRC Advanced Physiotherapy center department of Geriatric physiotherapy room no 20 sagar floor Belgavi Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  8766472578  
Fax    
Email  mamatatharkar@gmail.com  
 
Source of Monetary or Material Support  
Recreational runners of KAHER Institute Belgavi  
 
Primary Sponsor  
Name  Self sponsored 
Address  KLES Dr prabhakar Kore hospital and MRC Advance physiotherapy clinic Nehru Nagar Belgavi 590010 karnataka  
Type of Sponsor  Research institution and hospital 
 
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 vinuta harpanhalli  KLES Dr Prabhakar Kore Hospital and MRC Nehru Nagar Belgavi 590010  KLE DR Prabhakar Kore Hospital and MRC Advanced Physiotherapy center department of Geriatric physiotherapy room no 20 sagar floor Belgavi Karnataka 590010 Belgaum KARNATAKA
Belgaum
KARNATAKA 
9714334270

vinutaharpanhalli@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics committee, KAHER Institute of Physiotherapy, Belgavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Iliotibial band syndrome 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Core strengthening exercises  1 to2 weeks activation of core muscle 3 to 4 weeks strengthen the core muscle 5 to 6 week improve stability in single leg stance and train anti rotational core stability  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Participants willing to participate in the study
Recreational runners of all gender
 
 
ExclusionCriteria 
Details  Individuals with a history of knee surgery or trauma within the past 6 months
Those with other lower limb injuries e g meniscal tears ligament injuries
Participants with diagnosed neurological disorders affecting lower limb function
Individuals currently engaged in a structured core strengthening program rehabilitation for Iliotibial Band Syndrome or any other exercise regime targeting core stability
Participants with systemic inflammatory conditions
e g rheumatoid arthritis
Individuals unable to perform basic core exercises due to medical or physical limitations or those who are pregnant
Participants who have received corticosteroid injections in the affected knee within the past month
Cardiovascular condition

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
VERBAL ANALOGUE SCALE  The Verbal Analog Scale (VAS) was recorded at baseline, mid-intervention, and post-intervention (weeks 0 and 6) to assess changes in pain intensity. 
 
Secondary Outcome  
Outcome  TimePoints 
lower extremity functional scale  The Lower Extremity Functional Scale (LEFS) was assessed at baseline, mid-intervention, and post-intervention (weeks 0 and 6) to evaluate functional improvement over the 6-week period. 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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 2 
Date of First Enrollment (India)   17/11/2025 
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="6"
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  
Iliotibial Band Syndrome (ITBS) is a common overuse injury among runners, characterized by pain on the lateral aspect of the knee due to irritation of the iliotibial band as it moves over the lateral femoral condyle during repetitive knee motion. Its etiology is multifactorial, involving both extrinsic factors (training load, surface, footwear) and intrinsic factors (muscle weakness, poor flexibility, altered biomechanics, and impaired neuromuscular control). The incidence of ITBS ranges from 5%–14%, with a higher prevalence in men. Two main anatomical theories explain its cause: the compression/enthesopathy and friction/impingement theories.The ITB functions dynamically, acting as a knee extensor below 30° of flexion and a flexor beyond that point, with peak impingement occurring around 30° of knee flexion. Biomechanical abnormalities such as excessive hip adduction, pelvic drop, weak hip abductors and external rotators, and poor core stability increase tension on the ITB and contribute to pain and dysfunction. Recreational runners—who constitute a major group affected—often demonstrate altered lower-limb kinematics, including reduced rearfoot eversion, tibial rotation, and hip adduction angles.Weakness of the lateral gluteal and core muscles may lead to excessive pelvic and trunk motion, further increasing ITB strain. Stretching alone does not effectively modify ITB properties; instead, attention to proximal biomechanics and neuromuscular control is crucial for prevention and rehabilitation.
 
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