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CTRI Number  CTRI/2025/08/092961 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of two different exercises on anterior knee pain. 
Scientific Title of Study   Efficacy of static versus dynamic streching of muscles around knee in anterior knee pain - A prospective randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha P Vandakudari 
Designation  Postgraduate student 
Affiliation  SDM College of Physiotherapy 
Address  OPD number 5 Ortho Physiotherpy Department, SDM College of Physiotherapy, SDM College of Medical Science and Hospital ,Manjushree Nagar Sattur, Dharwad - 580009 KARNATAKA

Dharwad
KARNATAKA
580009
India 
Phone  7899751011  
Fax    
Email  meghavandkudari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Megha P Vandakudari 
Designation  Postgraduate student 
Affiliation  SDM College of Physiotherapy 
Address  OPD number 5 Ortho Physiotherpy Department, SDM College of Physiotherapy, SDM College of Medical Science and Hospital ,Manjushree Nagar Sattur, Dharwad - 580009 KARNATAKA

Dharwad
KARNATAKA
580009
India 
Phone  7899751011  
Fax    
Email  meghavandkudari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajeev Kumar Lal 
Designation  Vice Principal, Professor and PG Guide, SDM College of Physiotherapy. 
Affiliation  SDM College of Physiotherapy 
Address  OPD number 5 Ortho Physiotherpy Department, SDM College of Physiotherapy, SDM College of Medical Science and Hospital ,Manjushree Nagar Sattur, Dharwad - 580009 KARNATAKA

Dharwad
KARNATAKA
580009
India 
Phone  9986202056  
Fax    
Email  lalrk@yahoo.com  
 
Source of Monetary or Material Support  
SDM College of Medical Sciences and hospital SDM College of Physiotherapy, Manjushree Nagar Sattur Dharwad Karnataka 580009 India 
 
Primary Sponsor  
Name  Megha P Vandakudari 
Address  SDM College of Medical Sciences and hospital SDM College of Physiotherapy, Manjushree Nagar Sattur Dharwad Karnataka 580009 India 
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 
Megha P Vandakudari  Shri Dharmastala Manjunatheshwara hospital  OPD number 5 Ortho Physiotherpy Department, SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad - 580009 KARNATAKA
Dharwad
KARNATAKA 
7899751011

meghavandkudari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of Medical Sciences and Hospital Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DYNAMIC STRETCHING (GROUP-2)  *Dynamic Hamstring Stretching:* 1) In the supine position, the affected leg will be maintained at 90° of flexion at both the hip and knee. The distal thigh will be stabilized using a towel; then, active knee extension will be performed up to end range. OR 2) In the standing position, this exercise will be performed by repeated hip flexion with the knee extended. • Parameters for Dynamic hamstring stretching: 15 repetitions with 1 second hold time for 3 sets, and resting time 2 to 3 minutes between each set, twice daily *Dynamic Quadriceps Stretching:* 1) In the prone position, the knee joint of the involved leg will be flexed maximally, followed by hip extension. OR 2) In the standing position, the involved leg will be maintained in maximum knee flexion( whatever possible), followed by hip extension movement actively. • Parameters for the Dynamic quadriceps stretching: 15 repetitions with 1 second hold time for 3 sets. Rest time 2 to 3 minutes between each set, twice daily. Subjects will come to PT department twice in a week for first 2 weeks then will come to once in a week for another 4 weeks. At the end of 6 weeks subjects will be reassessed for the same outcome measures, once the data will be collected it will be sent for analysis 
Comparator Agent  STATIC STRETCHING (GROUP-1)  *Static Hamstring Stretching:* 1) In long sitting position: with slight trunk forward flexion, the affected leg will be maintained in a straightened position with ankle dorsiflexion. The foot will be grasped using the ipsilateral hand or a towel and with the contralateral hand maintaining the affected knee straight. OR 2) In the supine position the affected leg will be maintained in straight position with ankle dorsiflexion. The foot will be grasped using the towel or resistance band slowly lift the leg while keeping the knee straight. Gently pull the towel or band until stretch is felt. OR 3) Stand upright in front of a sturdy chair and place affected leg on it, keep the knee straight. Lean forward from the hips while keeping back straight until a gentle stretch in the back of thigh is felt. Parameters for static hamstring stretching: 30-60 seconds hold time for 3 sets. Rest time: 1 minute between each set, twice daily. *Static Quadriceps Stretching:* In the prone OR standing positions: the involved leg will be maintained full knee flexion, grasping the foot using the ipsilateral hand and the heel of the involved leg slowly pressed on the buttock. Parameters for the Static quadriceps stretching: 30-60 seconds hold time for 3 sets. Rest time: 1 minute between each set, Twice daily. Subjects will visit PT department twice in a week for initial 2 weeks then will come once in a week for another 4 weeks. At the end of 6 weeks subjects will be reassessed for the same outcome measures, once the data will be collected it will be sent for analysis. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Subjects with anterior knee pain with hamstring tightness. 2. Subjects with anterior knee pain with quadriceps tightness. 3. Age Ranges from 18 to 40 years. 4. Both male and female. 5. Unilateral 
 
ExclusionCriteria 
Details  1. Subjects with osteoarthritis, Recurrent patellar dislocation. 2. Any deformity in the lower limbs. 3. Any fracture in the lower limb past 6 months. 4. Subjects not willing to participate. 5. subjects who had neurological problems affecting lower limb past 6 months. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Visual analog scale
2. Anterior Knee pain scale (AKPS)
3. Knee Range of motion

 
At 0th day and 6th week

 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   08/09/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Efficacy of Static Versus Dynamic Stretching of Muscles Around the Knee in Anterior Knee Pain: A Prospective Randomized Controlled Trial.

Background
Anterior Knee Pain (AKP) is a common musculoskeletal complaint, affecting 15-45% of the population. It is often linked to muscle tightness, particularly in the quadriceps and hamstrings, which can alter patellar tracking and increase joint stress. Stretching is a standard intervention, but the comparative efficacy of static stretching (sustained holds) versus dynamic stretching (controlled movements) for AKP remains unclear due to conflicting evidence. This ambiguity highlights the need for further research to guide clinical practice.

Objective
This study aims to compare the therapeutic efficacy of static versus dynamic stretching interventions in individuals with Anterior Knee Pain. The primary objective is to assess and quantify changes in pain intensity (Visual Analog Scale - VAS), knee joint range of motion (ROM) (goniometrically), and functional disability (Anterior Knee Pain Scale - AKPS).

Methodology
This prospective randomized controlled trial will recruit 44 eligible participants (18-40 years) with unilateral AKP and hamstring/quadriceps tightness. Participants will be randomly allocated into two equal groups (22 each) using the Concealed Envelope Method. Both groups will receive a standardized common therapy protocol for six weeks. This protocol will include:

Therapeutic ultrasound: Applied to the affected knee area to reduce pain and inflammation.

Open kinetic chain exercises: These exercises involve movements where the distal segment (e.g., foot) is free to move in space, such as knee extensions for quadriceps strengthening or hamstring curls.

Balance exercises: Activities designed to improve proprioception and stability around the knee joint, such as single-leg stands or wobble board exercises.

In addition to the common therapy, each group will receive a specific stretching intervention:

Group A (Static Stretching): Participants in this group will perform static stretching exercises targeting the tight hamstring and/or quadriceps muscles. The protocol will involve 3 sets of 3 repetitions, with each stretch held for a sustained duration of 30 to 60 seconds. Stretches will be performed to the point of mild discomfort, not pain, allowing for a prolonged elongation of the target muscles. Examples include standing hamstring stretch or quadriceps stretch.

Group B (Dynamic Stretching): Participants in this group will engage in dynamic stretching exercises, which involve controlled, rhythmic movements through the full range of motion of the target muscles (hamstrings and/or quadriceps). The protocol will consist of 3 sets of 15 repetitions, with each movement held briefly for approximately 1 second at the end range. These movements emphasize active mobility and functional movement patterns relevant to knee function, such as leg swings (forward and backward for hamstrings, side-to-side for hip flexors/quadriceps) or controlled lunges.

Outcome measures (VAS, ROM, AKPS) will be collected at baseline (pre-intervention) and after the six-week intervention period (post-intervention). Statistical analysis will use paired t-tests to evaluate within-group changes from baseline to post-intervention. Independent t-tests will be used to compare the differences in outcomes between Group A and Group B. The level of statistical significance for all analyses will be set at a p-value of less than 0.05.


 
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