| 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
|
|
|
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
|
|
|
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. |