| CTRI Number |
CTRI/2024/09/074518 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| 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
|
Comparing the effect of whole-body neuromuscular training with exercises that focus only on hip strengthening to see which is better for improving knee function in patients with knee pain (patellofemoral pain syndrome). |
|
Scientific Title of Study
|
Comparison of Core Neuromuscular Training versus Isolated Hip Strengthening Exercises on Reducing Pain and Improving Knee Functional Performance in Patients with Patellofemoral pain Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya k |
| Designation |
PG Student |
| Affiliation |
Narayana Hrudayalaya |
| Address |
Hosur road anekal, Taluk , Bommasandra Industrial Area, Bengaluru karanataka 560099
Hosur road anekal, Taluk , Bommasandra Industrial Area, Bengaluru karanataka 560099
Bangalore
KARNATAKA
560099
India |
| Phone |
7829188432 |
| Fax |
|
| Email |
aishwaryaaishwarya623@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr smruti swagatika dash |
| Designation |
professor |
| Affiliation |
Narayana Hrudayalaya |
| Address |
Hosur road anekal, Taluk , Bommasandra Industrial Area, Bengaluru karanataka 560099
Hosur road anekal, Taluk , Bommasandra Industrial Area, Bengaluru karanataka 560099
Bangalore
KARNATAKA
560099
India |
| Phone |
7829188432 |
| Fax |
|
| Email |
nhaec@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya k |
| Designation |
PG Student |
| Affiliation |
Narayana Hrudayalaya |
| Address |
Hosur road anekal, Taluk , Bommasandra Industrial Area, Bengaluru karanataka 560099
Hosur road anekal, Taluk , Bommasandra Industrial Area, Bengaluru karanataka 560099
Bangalore
KARNATAKA
560099
India |
| Phone |
7829188432 |
| Fax |
|
| Email |
aishwaryaaishwarya623@gmail.com |
|
|
Source of Monetary or Material Support
|
| 258/A, Hosur Road, Bommasandra Industrial Area, Narayana Health City Rd, Electronic City, Bengaluru, Karnataka 560099 |
|
|
Primary Sponsor
|
| Name |
Narayana hrudayalaya institute |
| Address |
Bommasandra Industrial Area Anekal hosur raod, Bangalore karnataka 560099 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Aishwarya k |
Narayana orthopaedic center |
Department of physiotherapy and Rehabilitation - international wing Room no 101
Bangalore
KARNATAKA |
7829188432
aishwaryaaishwarya623@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana health academic ethics committee |
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: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
core neuromuscular strengthening exercise |
•This group will undergo core neuromuscular training in addition to routine physical therapy exercises for PFPS participants. The physical therapy exercise program focused mainly on strengthening the knee muscles (mainly quadriceps and hamstring) and flexibility exercises for the gastrocnemius, iliotibial band, and hamstring muscles The participants were taught how to contract their deep abdominal muscles to obtain core muscle activation.
•The patient should contract the abdominal muscles, lifting her lower belly away from the pubic bone, while breathing slowly and normally. The patient should not hold her breath
frequency of each exercise 5-10 repetions perfomed twice daily
for almost 8-9months
Each treatment session was approximately 50 min in duration, all sessions were performed individually
|
| Comparator Agent |
Isolated hip strenthening exercise |
•Each treatment session was approximately 50 min in duration, all sessions were performed individually and supervised by the same physical therapist HIP strengthening group (HG).
•This group performed exercises to strengthen hip stabilizing muscle exercises chosen to strengthen the muscles of the hip & knee &lead to increased stabilization of the hip & knee joints
each exercise will be
frequency of exercise will be performed 5-10 repetations |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
years of age : 20-50 years
History of at least 3 months of retro patellar pain during prolonged sitting, kneeling, climbing stairs, squatting, running, kneeling, hopping, jumping [ pain should be provoked during these activities] anterior knee pain with a minimum intensity of 3 or greater on the 10-cm visual analog scale (VAS)
Subjects who are willing to participate in the study with symptoms of patellofemoral pain syndrome |
|
| ExclusionCriteria |
| Details |
x-ray & MRI indicative of meniscal injury or other intra-articular injury
Increased laxity of cruciate or collateral or other pathologies including OA & knee joint effusion
The subjects who fulfill the Inclusion & exclusion criteria and are willing to participate in the study will be assigned one of the groups after obtaining written informed consent |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale (VAS) Pain levels will be measured by using the VAS scale on the day of assessment before intervention (pre-treatment) and after intervention (post-treatment).
|
Visual Analog Scale (VAS) Pain levels will be measured by using the VAS scale on the day of assessment before intervention (pre-treatment) and after intervention (post-treatment).
Using Kujala anterior knee pain scale This validated questionnaire assesses various aspects related to anterior knee pain and functional limitations, providing a comprehensive evaluation of PFPS symptoms and their impact on daily activities
Both scales will be used after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Using Kujala anterior knee pain scale This validated questionnaire assesses various aspects related to anterior knee pain and functional limitations, providing a comprehensive evaluation of PFPS symptoms and their impact on daily activities |
After 4 weeks of intervention |
| kujala anterior knee pain scale |
after 4 weeks of intervention |
step down performance
balance differences (anterior,posteromedial,posterolateral) |
after 4 weeks of treatment intervention |
step down improvement
balance differences |
after 4 weeks of treatment intervention |
|
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Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
02/10/2024 |
| 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="24"
Months="1"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
AIM: To compare the effectiveness of core neuromuscular training and isolated hip strengthening exercises in reducing pain intensity and improving knee functional performance among patients diagnosed with patellofemoral pain syndrome OBJECTIVES PRIMARY OBJECTIVE- To compare the effect of core neuromuscular training and isolated hip strengthening in patients with patellofemoral pain syndrome SECONDARY OBJECTIVE- To evaluate whether core neuromuscular training and isolated hip strengthening are effective in improving pain intensity in subjects with patellofemoral pain syndrome To evaluate core neuromuscular training and isolated hip strengthening effective in improving functionality in subjects with patellofemoral pain syndrome
To assess whether core neuromuscular training and isolated hip strengthening are effective in improving range & alleviating pain Hypothesis- Null Hypothesis [H0]: 1. There will be no significant effects of core neuromuscular training on pain & functionality of patellofemoral pain syndrome. 2. There will be no significant effect of isolated hip strengthening on pain & functionality of patellofemoral femoral pain syndrome. 3. There will be no significant difference in core neuromuscular training compared to isolated hip strengthening on pain & functionality in patellofemoral pain syndrome. Alternate Hypothesis [H1]: 1. There will be a significant effect of core neuromuscular training on pain & functionality on patellofemoral pain syndrome. 2. There is a significant effect of isolated hip strengthening on pain & functionality in patellofemoral pain syndrome 3. There will be a significant difference in core neuromuscular training compared to isolated hip strengthening on pain and functionality in patellofemoral pain syndrome.
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