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CTRI Number  CTRI/2025/01/079743 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparing the effects of fixed leg exercises with freely moving leg exercises in people with pain behind the knee cap for improvement in pain and quality of life. 
Scientific Title of Study   Comparing the effects of open and closed kinetic chain exercises on pain and functionality in patellofemoral pain syndrome A Pilot Randomized Clinical Trials.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanumuri Sri Harsha  
Designation  Undergraduate student  
Affiliation  GITAM school of physiotherapy, GITAM institute of medical sciences and research 
Address  Room number: 01, department of physiothearpy, GITAM school ofphysiotherapy, GITAM institute of medical sciences and research, Gandhi nagar, Rushikonda, Vishakapatnam.

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  8008420500  
Fax    
Email  kanumurisriharsha.05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kanumuri Sri Harsha  
Designation  Undergraduate student  
Affiliation  GITAM school of physiotherapy, GITAM institute of medical sciences and research 
Address  Room number: 01, department of physiothearpy, GITAM school ofphysiotherapy, GITAM institute of medical sciences and research, Gandhi nagar, Rushikonda, Vishakapatnam.

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  8008420500  
Fax    
Email  kanumurisriharsha.05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satish Kumar Anumula  
Designation  Associated Professor 
Affiliation  GITAM school of physiotherapy, GITAM institute of medical sciences and research 
Address  Room number: 01, department of physiothearpy, GITAM school ofphysiotherapy, GITAM institute of medical sciences and research, Gandhi nagar, Rushikonda, Vishakapatnam.

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  8095718023  
Fax    
Email  satish.anumula@gmail.com  
 
Source of Monetary or Material Support  
Room number: 01, department of physiothearpy, GITAM school of physiotherapy, GITAM institute of medical sciences and research, Gandhi nagar, Rushikonda, Vishakapatnam, 530045, Andhra Pradesh, India  
 
Primary Sponsor  
Name  Kanumuri Sri Harsha  
Address  GITAM school of physiotherapy, GITAM Institute of medical sciences and research, Gandhi nagar, Rushikonda, Vishakapatnam, Andhra Pradesh, 530045 
Type of Sponsor  Other [self-funded ] 
 
Details of Secondary Sponsor  
Name  Address 
Shipra  GITAM school of physiotherapy, GITAM Institute of medical sciences and research, Gandhi nagar, Rushikonda, Vishakapatnam, Andhra Pradesh, 530045 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kanumuri Sri Harsha   GITAM institute of medical sciences and research.  Room number: 01, department of physiothearpy, GITAM school ofphysiotherapy, Gandhi nagar, Rushikonda, Vishakapatnam.
Visakhapatnam
ANDHRA PRADESH 
8008420500

kanumurisriharsha.05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics commitee GIMSR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M222||Patellofemoral disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Closed chain kinetic exercises   Involves stabilizing the distal segment and moving the proximal segment to perform exercise. They primary focuses on eccentric contraction and co-contraction of muscles and aids in the improvement of joint stability. The exrcise duration would last for 6 weeks.  
Intervention  Open kinetic chain exercise   The proximal segment is fixed whi;e distal segment moves to perform exercise. this exercises mainly focuses on isolating a muscle or muscle group. The exercise duration would last for 6 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Pre-diagnosed subjects with patellofemoral pain syndrome.
2. Pain on palpation around patella

The patient should have at least three of the following symptoms:
- Persistent anterior knee pain for over 6 months.
- Pain with prolonged sitting.
- Pain while stair ascent or descent.
- Pain with squatting.
- Pain of anterior knee during activities while weight bearing.
 
 
ExclusionCriteria 
Details  Subjects with osteoarthritis, chondromalacia patella, any history of ligament or meniscus injury or history of patellar subluxation, bursitis, referred pain from hip and lumbar region, and pregnant women are excluded from our study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Kujala scale and numerical pain rating scale   At baseline, 2nd week, 3rd week, 4th week, 5th week and 6th week.  
 
Secondary Outcome  
Outcome  TimePoints 
RPE   At baseline, 2nd week, 3rd week, 4th week, 5th week & 6th week.  
muscle girth  At baseline & 6th week  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   28/02/2025 
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 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  

Patellofemoral pain syndrome (PFPS) is the most common cause of anterior knee pain in adolescents and young adults. Gaitonde DY et al., 2019 defined it as pain around or behind the patella that is aggravated by activities that load the patella during weight bearing on the flexed knee. There are many aetiological factors contributing to PFPS. Juhn MS et al., 1999 stated that causes could be overloading due to overuse or overweight, type of foot, muscular causes such as weakness of quadriceps, vastus medialis, hip musculature, or inflexibility like the tightness of the iliotibial band, hamstrings, and calf muscles.

PFPS is also referred to as runner’s knee or anterior knee pain. Annual prevalence in the general population was reported as 22.7%, with the annual prevalence in females 29.2% and males 15.5% and an incidence rate of 1.9% (Bump JM et al., 2023).  Patellofemoral pain is often misdiagnosed as patellofemoral OA, Osgood Schlatter’s disease, plica, bursitis (prepatellar or Hoffa’s), Saphenous neuritis, quadriceps tendinopathy, patellar tendinopathy, or referred pain from hip or back, chondromalacia patella (Smith BE et al., 2018).


Conventional treatment for PFPS primarily focuses on knee strengthening. A study conducted by Avraham F et al., 2007 aiming to find effective physiotherapy treatment for PFPS included 30 participants, divided into group I (received knee rehabilitation and transcutaneous electrical nerve stimulation), group 2 (received hip rehabilitation with stretching) and group 3 (received both the interventions). Results showed significant improvement in terms of pain after 3 weeks but group 2 and group 3 showed significant increase in muscle power when compared to group 1. With the advances in research, now along with knee strengthening, the equal emphasis is being placed on hip strengthening as well. A systematic review conducted by Nascimento LR et al., 2018 on the effectiveness of hip and knee strengthening showed better improvement in pain and activity levels when compared to knee strengthening alone. 

Ferber R et al.,  2015 conducted a study on hip and core strengthening versus knee alone in PFPS. Both groups showed similar improvement in pain. The group that received the hip and core strengthening protocol showed earlier resolution of pain i.e. by the third week and increased level of endurance when compared to the knee strengthening protocol.

During recent decades the effects of kinetic chain exercises on patellofemoral pain have been a point of interest to researchers. Kinetic chain exercises are divided into open kinetic chain exercises (OKC) and closed kinetic chain exercises (CKC). In OKC, the proximal segment is fixed and the distal is moving. OKC mainly focuses on isolating a muscle or muscle group. While CKC involves stabilizing the distal segment and moving the proximal segment. CKC primarily focuses on eccentric contraction and co-contraction of muscles and aids in the improvement of joint stability. Kwon YJ et al., 2013  stated in their study comparing the effects of open and closed kinetic chain exercises, a 5-year prospective RCT that both open and closed kinetic chain exercises are equally beneficial for long-term good functionality. They used IRM for the progression of weights with a predetermined or fixed number of sets and repetitions. Similarly, many authors designed a protocol with predetermined progression. This can raise questions about a patient’s comfort levels. Thus, we wanted to design the exercise protocol based on the sessional rating of perceived exertion (RPE) and progress accordingly. To our knowledge, this is the first study to use RPE for the progression of resistance in kinetic chain exercises for patellofemoral pain. 


 
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