| CTRI Number |
CTRI/2025/01/079302 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
How Different Types of Exercise Help People with Knee Pain Improve Movement and Reduce Discomfort |
|
Scientific Title of Study
|
Effectiveness of Open and Closed Kinetic Chain Exercises on Quadriceps Muscle Thickness, Pain and Functional Performance in Patellofemoral Pain Syndrome among Recreational Players |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Buvanesh Annadurai |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
5th Floor,A5-Department of Sports and Manual therapy,
Saveetha College of Physiotherapy,
Saveetha Institute of Madical and Technical Sciences,
Saveetha Nagar,
Thandalam,
Chennai.
Chennai TAMIL NADU 602105 India |
| Phone |
8754123645 |
| Fax |
|
| Email |
buvanesh21896@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Buvanesh Annadurai |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
5th Floor,A5-Department of Sports and Manual therapy,
Saveetha College of Physiotherapy,
Saveetha Institute of Madical and Technical Sciences,
Saveetha Nagar,
Thandalam,
Chennai.
Chennai TAMIL NADU 602105 India |
| Phone |
8754123645 |
| Fax |
|
| Email |
buvanesh21896@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Buvanesh Annadurai |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
5th Floor,A5-Department of Sports and Manual therapy,
Saveetha College of Physiotherapy,
Saveetha Institute of Madical and Technical Sciences,
Saveetha Nagar,
Thandalam,
Chennai.
Chennai TAMIL NADU 602105 India |
| Phone |
8754123645 |
| Fax |
|
| Email |
buvanesh21896@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha College of Physiotherapy,
Saveetha Institute of Medical and Technical Sciences,
Saveetha Nagar,
Thandalam,
Chennai
Tamilnadu
India
602105 |
|
|
Primary Sponsor
|
| Name |
Buvanesh Annadurai |
| Address |
5th Floor,A5-Department of Sports and Manual therapy,
Saveetha College of Physiotherapy,
Saveetha Institute of Madical and Technical Sciences,
Saveetha Nagar,
Thandalam,
Chennai,
Tamilnadu,
India.
602105 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Vinodhkumar Ramalingam |
Saveetha Medical College and Hospital (SMCH) |
Room No.105, 1st Floor,
Saveetha Institute of Medical and Technical Sciences (SIMATS),
Saveetha Nagar,
Thandalam,
602105 Chennai TAMIL NADU |
8760563032
vinodhkumar.scpt@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee (SMCH-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Closed Kinetic Chain Exercices |
Double or single one-third knee bend,
Stationary biking,
Step up and down exercise,
Lunges,
Progressive jumping exercises on a mini trampoline along with Therapeutic Ultrasound and McConnell Taping - 5 weeks |
| Comparator Agent |
Conventional Therapy |
Conventional Therapy along with Therapeutic Ultrasound and McConnell Taping - 5 weeks |
| Intervention |
Open Kinetic Chain Exercices |
Maximal static quadriceps contractions (quadriceps setting),
Straight leg raisings in supine position,
Short arc movements (10° to terminal extension),
Seated knee extension,
Leg adduction exercises in lateral decubitus position along with Therapeutic Ultrasound and McConnell Taping - 5 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Symptoms of PSFS for at least 3 months.
Having pain between 3 to 6 in Numeric Pain Rating Scale (NPRS).
Having knee pain at least in two activities among stair ascent and descent, prolonged sitting with the knees flexed, squatting over 90 degrees, running, jumping and kneeling.
Experiencing pain in one of the following clinical tests:
1.Pain during Apprehension test.
2.Pain or tenderness during McConnell Test.
3.Pain during resistance is applied on superior border of patella during isometric contraction of the quadriceps (Clarke’s test).
|
|
| ExclusionCriteria |
| Details |
History of knee surgery, bursitis and arthritis.
History of patella subluxation or dislocation, anterior or posterior cruciate ligament insufficiency.
Referral pain from spinal cord or nerve roots.
Ligament rupture, articular capsule or meniscus injury.
Tendon and muscle ruptures in lower extremity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasound Imaging |
5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale (NPRS) |
5 weeks |
| Anterior Knee Pain Scale (AKPS) |
5 weeks |
| Triple Hop Test |
5 weeks |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
01/04/2025 |
| 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="8" 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
|
This research investigates the effectiveness of Open Kinetic Chain (OKC) and Closed Kinetic Chain (CKC) exercises on quadriceps muscle thickness, pain, and functional performance in recreational players with Patellofemoral Pain Syndrome (PFPS). PFPS is a common condition that leads to knee pain, particularly in athletes and active individuals, affecting their daily activities and performance. The study aims to fill the gap in existing literature by comparing the effects of OKC and CKC exercises, which are widely used in rehabilitation, on improving quadriceps function and alleviating symptoms in recreational athletes. The study will involve 75 participants, randomly assigned to three groups: OKC exercises, CKC exercises, and conventional therapy. The interventions will include exercises along with therapeutic ultrasound and McConnell taping. Outcome measures will include ultrasound imaging for muscle thickness, the Numeric Pain Rating Scale (NPRS) and Anterior Knee Pain Scale (AKPS) for pain and function, and the Triple Hop Test for functional performance. The results will be analyzed using ANOVA to determine the significant differences between the exercise groups. This study will provide valuable insights into the most effective rehabilitation strategies for managing PFPS in recreational players, helping to improve their muscle strength, reduce pain, and enhance functional capabilities. |