| 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 |
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Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
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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. |
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Scientific Title of Study
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
|
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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 |
|
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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 ] |
|
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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 |
|
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Countries of Recruitment
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India |
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Sites of Study
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| 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 |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics commitee GIMSR |
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: M222||Patellofemoral disorders, |
|
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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. |
|
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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.
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| 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. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Other |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Kujala scale and numerical pain rating scale |
At baseline, 2nd week, 3rd week, 4th week, 5th week and 6th week. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| RPE |
At baseline, 2nd week, 3rd week, 4th week, 5th week & 6th week. |
| muscle girth |
At baseline & 6th week |
|
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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