| CTRI Number |
CTRI/2025/01/079514 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Knee Alignment Exercises vs. Standard Treatment on Pain, Strength, and Mobility in People with Knee Pain |
|
Scientific Title of Study
|
Effect of valgus control instruction exercises versus conventional treatment on pain, strength and function in patients with patellofemoral pain syndrome -An experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rasika Sawarkar |
| Designation |
MPT |
| Affiliation |
MAEERS Physiotherapy College Talegaon Dabhade |
| Address |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade
Pune MAHARASHTRA 410507 India |
| Phone |
09422326959 |
| Fax |
|
| Email |
rasikaps24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Snehal Ghodey |
| Designation |
Professor |
| Affiliation |
MAEERS Physiotherapy College Talegaon Dabhade |
| Address |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade
Pune MAHARASHTRA Dr Snehal Ghodey India |
| Phone |
09422326959 |
| Fax |
|
| Email |
gsnehavi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Snehal Ghodey |
| Designation |
Professor |
| Affiliation |
MAEERS Physiotherapy College Talegaon Dabhade |
| Address |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade
Pune MAHARASHTRA Dr Snehal Ghodey India |
| Phone |
09422326959 |
| Fax |
|
| Email |
gsnehavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAEERS Physiotherapy College Talegaon Dabhade
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade Pune India 410507 |
|
|
Primary Sponsor
|
| Name |
MAEERs Physiotherapy College |
| Address |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade Pune India 410507 |
| Type of Sponsor |
Private medical college |
|
|
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 Snehal Ghodey |
MAEERS Physiotherapy College |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade, Pune India 410507 Pune MAHARASHTRA |
9422326959
gsnehavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERS College of Physiotherapy ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
Conventional tretament |
The conventional protocol given will be stretching of hamstrings, iliotibial band, hip flexors and calf muscles 30 sec hold 3 repetitions each, strengthening of quadriceps, hip abductors and external rotators and core muscles by calculating 10 repetition maximum and balance training which includes tandem walking, narrow base of support with eyes open and then closed and single leg standing. |
| Intervention |
Valgus control instruction exercises |
Valgus control instruction exercises are a set of exercises formulated to manage patients with patellofemoral pain syndrome. Is is a set of 16 exercises. The duration of exercises is 6 weeks. These exercises mainly focus on the alignment of the knee while performing exercises. Internal focus instructions like keep the knee over toe, land with flexed knee and external focus like try to land on the floor markers are used to draw patients attention. External Focus instructions employ unconscious or instinctive processes to more efficiently support motor learning. VCI exercises can correct knee valgus angle through reeducation of motor controls.
Exercises performed in first week are Squat in front of mirror 0°-60° of knee flexion 10 repetitions with 5 sec hold 2 sets of 10 repetitions with 5 second hold, Squat 0°-60° of knee flexion 2 sets of 20 repetitions with 5 sec hold, Lateral walk with elastic resistance around the forefoot 2 sets of 20 repetitions with 5 sec hold. Exercises performed in 2nd week are Pelvic drop while standing 3 sets of 12 repetitions, Squat with elastic resistance 0°-60° of knee flexion 3 sets of 12 repetitions with 10 second hold, Squat on BOSU ball 2 sets of 20 repetitions 5 sec hold, Forward lunge in front of mirror 3 sets of 12 repetitions, Forward lunge, Balance exercise on BOSU Ball 3 sets of 20 seconds, Exercises performed in 3rd week are Single-leg balance at 30° of knee flexion 3 sets of 12 repetitions, Squat with elastic resistance around the knees 3 sets of 12 repetitions, Unipedal squat on BOSU ball 3 sets of 12 repetitions, Modified forward lunge with elastic around the knee 3 sets of 12 repetitions, Romanian deadlift 3 sets of 12 repetitions, Lateral sliding without jumping 3 sets of 12 repetitions, Hip lateral rotation 3 sets of 12 repetitions.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Anterior knee pain patients diagnosed by Orthopedic
The clinical practice guideline for PFPS by The American Physical Therapy Association diagnostic criteria:
Presence of retro patellar or peripatellar pain
Reproduction of retro patellar or peripatellar pain during squatting, or other functional activities loading the PFJ in a flexed position
|
|
| ExclusionCriteria |
| Details |
Previous surgery in lower limb
Any other diagnosed knee and hip conditions
Patellar instability/ subluxation
Low back pain referring pain to knee
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain (visual analogue scale), strength (hand held dynamometer) |
pre and post intervention 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| function (anterior knee pain scale) |
pre and post intervention 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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 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
|
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Brief Summary
|
Patellofemoral pain syndrome (PFPS) is a prevalent knee condition characterized by pain around or behind the patella, typically worsened by activities like squatting, running, or stair climbing that place stress on the knee. It affects a broad range of people, especially young, active individuals and athletes, with a higher prevalence in females due to factors such as greater quadriceps angle (Q angle) and dynamic valgus. PFPS is often caused by a misalignment in patellar tracking during knee movement, with biomechanical issues like weak lower extremity muscles, tightness in structures around the knee, and foot overpronation contributing to the condition. Recent studies explore the impact of valgus control instruction (VCI) exercises, which aim to correct knee valgus by re-educating motor control. Exercise instructions can be categorized into internal focus (IF), which directs attention to body movements, and external focus (EF), which focuses on movement outcomes. EF instructions are thought to better facilitate motor learning by encouraging instinctive responses. VCI exercises show promise in improving knee alignment, particularly in comparison to conventional treatments, offering a potential benefit in managing PFPS. A visual analog scale will be used to evaluate anterior knee pain in participants who meet the inclusion criteria. A dynamometer will be used to measure quadriceps, hip abductors, and external rotators strength, and an anterior knee pain scale will be used to evaluate function. Using the simple random sampling technique, the participants who meet the inclusion requirements will be divided into two groups. For six weeks, one group will receive traditional treatment three times a week, while the other group will receive exercises involving valgus control teaching three times a week. All the three outcomes will be assessed after 6 weeks of intervention. Data will be collected and analyzed. |