| CTRI Number |
CTRI/2024/05/067719 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| 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
|
In our study we will be including patients with knee osteoarthritis. We will be giving Patellar Tendon Loading Exercises to see its effect on functional disability, pain and motor recruitment of quadriceps muscle. |
|
Scientific Title of Study
|
Effectiveness of Patellar Tendon Loading Exercises on Functional Disability, Pain and Electromyographic Activity of Quadriceps Muscle in Patients with Knee Osteoarthritis - A Pilot Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Manghwani |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-4, MGM Institute of Physiotherapy,
Aurangabad.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7840966474 |
| Fax |
|
| Email |
divimanghwani8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-4, MGM Institute of Physiotherapy,
Aurangabad.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
sanketmungikar@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-4, MGM Institute of Physiotherapy,
Aurangabad.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
sanketmungikar@mgmiop.edu.in |
|
Source of Monetary or Material Support
Modification(s)
|
| MGM Institute of Physiotherapy
N-6 Cidco, Aurangabad,431003
Maharashtra,India. |
|
Primary Sponsor
Modification(s)
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6 Cidco, Aurangabad,431003
Maharashtra,India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Divya Sevakram Manghwani |
MGM medical college and Hospital |
Musculoskeletal Physiotherapy Department, OPD-1,MGM Institute of Physiotherapy, N-6 Cidco, Aurangabad
Aurangabad
MAHARASHTRA |
7840966474
divimanghwani8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Reseach on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Conventional Physiotherapy[IFT + Exercises(Isometric quadriceps exercise,Isometric hamstring exercise,Straight leg raising(SLR) exercise, Isometric hip adduction exercise, Hip abduction exercise, Hip Extension exercise, Dynamic Quadriceps)] will be given to knee osteoarthritis patients, 3 sessions/week for 6 weeks
|
| Intervention |
Patellar Tendon Loading Exercises and conventional physiotherapy |
Progressive Patellar Tendon Loading Exercises(which includes progression of 5 exercises: 1)walking to interval jogging 2)step ups and step down 3)squats 4) lunge 5)Decline squats) will be given along with conventional physiotherapy to knee osteoarthritis patients, 3 sessions/week for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both genders.
2.Age group 45-60 years.
3.Patients with Kellgren Lawrence grade 1 and grade 2(Diagnosed Mild OA).
4.Patients with activity related joint pain.
5.Patients with functional difficulty.
|
|
| ExclusionCriteria |
| Details |
1.Patients with H/O of Knee surgery (Arthroplasty / arthroscopy) or Fracture.
2.Patient received Intra-articular injection in last 3 months.
3.Patient with Diagnosed Osteoporosis grade 3.
4.Patients with systemic conditions like RA.
5.Patients with neurological conditions(Parkinson Disease, stroke).
6.BMI more than 30.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional Disability |
Pre and Post Intervention Period (6 week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain |
Pre and Post Intervention Period (6 week) |
| Electromyographic Activity of Quadriceps Muscle |
Pre and Post Intervention Period (6 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/05/2024 |
| 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
|
Patients with Knee Osteoarthritis will be included in
the study trial if they met the inclusion criteria. The written and oral
consent of all patients will be taken, and procedure will be explained.
Demographic data will be noted. Baseline data which include Functional Disability,
pain and Electromyographic Activity of Quadriceps Muscle will be assessed. The
patients will be randomly divided into two study groups intervention group and
control group. The patients will receive intervention as per the group
allocation for 6 weeks. The intervention group will receive Progressive
Patellar Tendon Loading Exercises in addition to the conventional physiotherapy
whereas the control group will receive conventional physiotherapy only. Patellar
Tendon Loading Exercises include progression of 5 exercises (1-Waking to
interval jogging, 2-Step ups and Step down, 3-Squats, 4- Lunges, 5-Decline
Squats) will be given 3 sessions/week for 6 weeks. Conventional Physiotherapy
Includes IFT + Exercises (Isometric quadriceps exercise, Isometric hamstring
exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abduction exercise, Hip Extension
exercise, Dynamic Quadriceps) will be given 3 sessions/week for 6 weeks. All
participants will be receiving one session of 30-40 minutes per day. Outcome
measures will be assessed pre and post intervention period. Statistical
analysis of the collected data will be done. Conclusion will be established
based on the obtained results of the study. |