| CTRI Number |
CTRI/2024/10/075016 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the impact of Backward Drill Exercises on Pain reduction and Strength Improvement in Athletes with Patellofemoral Pain Syndrome |
|
Scientific Title of Study
|
Efficasy of backward drill exercise Protocol in allievating pain and enhancing strength in athletes 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 |
Aniruddh C Ratnaparkhi |
| Designation |
Student researcher |
| Affiliation |
Lovely Professional University |
| Address |
Room no 105, Department of Physiotherapy, Lovely Professional University, Phagwara, Punjab
Kapurthala
PUNJAB
144411
India |
| Phone |
8885376581 |
| Fax |
|
| Email |
ratnaparkhianiruddha3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aniruddh C Ratnaparkhi |
| Designation |
Student researcher |
| Affiliation |
Lovely Professional University |
| Address |
Room no 105, Department of Physiotherapy, Lovely Professional University, Phagwara, Punjab
PUNJAB
144411
India |
| Phone |
8885376581 |
| Fax |
|
| Email |
ratnaparkhianiruddha3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Sadhu |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Room no 105, Department of Physiotherapy, Lovely Professional University, Phagwara, Punjab
Kapurthala
PUNJAB
144411
India |
| Phone |
9596857767 |
| Fax |
|
| Email |
sakshi.22851@lpu.co.in |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University, Phagwara, Punjab, 144411 |
|
|
Primary Sponsor
|
| Name |
Aniruddha C Ratnaparkhi |
| Address |
Room no 105, Department of Physiotherapy, Lovely Professional University, Phagwara, Punjab |
| Type of Sponsor |
Research institution |
|
|
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 |
| Aniruddh C Ratnaparkhi |
Lovely Professional University |
Room no 105, Department of physiotherapy, Lovely professional university, Phagwara, Punjab.
Kapurthala
PUNJAB |
8885376581
ratnaparkhianiruddha3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Lovely Professional University |
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 |
| Comparator Agent |
Control group |
Conventional physiotherapy management (TENS, Ultrasound therapy, Mild home based exercises) for 4 weeks |
| Intervention |
Intervention group |
Backward drill exercises for 4 weeks, 4 days per week, 35 to 90 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI- 17.9 to 24.9
2. Population- Athletes (Endurance Sports involving long distance running)
3. Anterior Knee Pain
4. Positive Clarke’s Sign
5. Pain during prolonged standing and walking
6. Pain while ascending and descending stairs
7. Pain while Running
8. Pain in High impact Activities (Jumping, Landing, Sprinting, Squatting)
9. Pain while kneeling and Cross leg sitting
|
|
| ExclusionCriteria |
| Details |
1. Age- Below 18 and above 25
2. Athletes without Anterior knee pain
3. History of Knee surgery
4. Acute knee Injuries
5. Diagnosed Metabolic disorders.
6. Diagnosed Meniscal and ligament injuries.
7. Negative Clarke’s Sign
8. Diagnosed Psychological Disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain - Visual Analogue Scale
Strength - Hand Held Dynamometer
Peak Power - Vertical jump |
0 week - Baseline
4th week - Post interventional |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Performance |
0 week - Baseline
4th week - Post interventional |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="0"
Months="6"
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), often termed anterior knee pain or chondromalacia patellae, is a
prevalent condition among athletes, particularly those involved in prolonged
running or jumping activities.
The syndrome is characterized by gradual pain that exacerbates during specific movements and
activities, such as descending stairs, squatting, or standing for extended periods. While the
pain can be temporarily relieved through rest, icing, or hot fomentation, the condition frequently
recurs due to treatments focusing primarily on symptom relief rather than addressing underlying
causes like patellar mal-tracking or muscle imbalances. This study aim to
alleviate pain and correct muscle imbalances, with innovative approaches like backward walking
exercises showing promise in strengthening the vastus medialis obliquus (VMO) muscle, thereby
improving patellar stability and reducing recurrence. |