| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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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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