| CTRI Number |
CTRI/2026/03/107164 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| 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 Patient Education and Exercise Compared to Exercise Alone on Knee Pain and Function in People with Knee Arthritis |
|
Scientific Title of Study
|
Comparing Effect of Blended Structured Education Approach And Neuromuscular Exercises To Only Neuromuscular Exercises On Pain, Functional Performance And Disability In Patients With Knee Osteoarthritis –A Randomized Control 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 |
PALLAVI DHARMRAJ CHOPADE |
| Designation |
PhD Scholar |
| Affiliation |
Dr.Vitthalrao Vikhe Patil Foundations College Of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy ,Ground floor Room no.4
Dr.Vitthalrao Vikhe Patil Foundations College Of Physiotherapy,Opp.Govt.Milk Dairy,Post.MIDC,Ahmednagar-414111,Maharashtra India
Department of Musculoskeletal Physiotherapy,3rd Floor,Room No.2
Dr.D.Y.Patil College of Physiotherapy,Dr.D.Y.Patil Vidyapeeth,Sant Tukaram Nagar,Pimpri,Pune-411018,Maharashtra India
Pune
MAHARASHTRA
414111
India |
| Phone |
9860571465 |
| Fax |
|
| Email |
pallavichopade11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Deepak Anap |
| Designation |
Professor and Head of the department |
| Affiliation |
Dr.Vitthalrao Vikhe Patil Foundations College Of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy ,Ground floor Room no.4
Dr.Vitthalrao Vikhe Patil Foundations College Of Physiotherapy,Opp.Govt.Milk Dairy,Post.MIDC,Ahmadnagar-414111,Maharashtra India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9860571465 |
| Fax |
|
| Email |
deepak.anap@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PALLAVI DHARMRAJ CHOPADE |
| Designation |
PhD Scholar |
| Affiliation |
Dr.Vitthalrao Vikhe Patil Foundations College Of Physiotherapy |
| Address |
Dr.Vitthalrao Vikhe Patil Foundations College Of Physiotherapy,Opp.Govt.Milk Dairy,Post.MIDC,Ahmednagar-414111 Maharashtra India
Department of Musculoskeletal Physiotherapy,3rd Floor,Room No.2
Dr.D.Y.Patil College of Physiotherapy,Dr.D.Y.Patil Vidyapeeth,Sant Tukaram Nagar,Pimpri,Pune-411018,Maharashtra ,India
Pune
MAHARASHTRA
414111
India |
| Phone |
9860571465 |
| Fax |
|
| Email |
pallavichopade11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Physiotherapy,Dr.D.Y.Patil Vidyapeeth,Sant Tukaram Nagar,Pimpri,Pune-411018 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil college of physiotherapy |
| Address |
Dr. D. Y.Patil college of Physiotherapy Dr. D. Y. Patil Vidyapeeth,Sant Tukaram Nagar, Pimpri ,Pune -411018 |
| 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 |
| DrPALLAVI DHARMRAJ CHOPADE |
Dr D Y Patil college of physiotherapy pimpri pune |
Out Patient Deaprtment ,ground floor Dr.D.Y.Patil College of Physiotherapy,Dr.D.Y.Patil Vidyapeeth,Sant Tukaram Nagar Pimpri, Pune 411018
Pune
MAHARASHTRA |
09860571465
pallavichopade11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil College of Physiotherapy pimpri Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blended structured education approach + Neuromuscular exercise |
The structured education approach will consist of evidence based education6-10,13
integrated with the answers formulated by expert group to FAQs of patients with OA.
The structured education approach will consist of a minimum of three theoretical
sessions of about 90 minutes (30 min each session), held as group sessions, with 7–12
participants in each group in 1st week on 3 consecutive days. The sessions will be
delivered using a power-point presentations
The first session will cover the anatomy of knee joint, etiology of OA, signs and
symptoms, risk factors (30min).
The second session will cover the importance of exercises, modification of daily life
activities, explanation of coping strategies and treatment options available (30min).
The third session will be a communication session with patients to solve the queries
related to previous sessions and exercises.
Following this they will perform supervised neuromuscular exercises 2sets of 10-15
repetitions 3/week for 12 weeks.
3,6,10
Patients will also receive pre-recorded videos of each session after they attend it to
refer them at home on mobile |
| Comparator Agent |
Neuromuscular training program |
Part 1. Warming up
Ten minutes of ergometer cycling will comprise the warm-up. Each person will have a
different work load, which can be increased over the course of the ten minutes to a perceived
effort of "somewhat hard."
Part 2. Circuit program
Every exercise will consist of 2 to 3 sets of 10 to 15 repetitions, with a rest period that equals one set in between each set and exercise.
Part 3. Cooling down
The cooling down part consists of walking exercises forward and backwards, about 10
meters in each direction, in front of mirror, mobility exercises for the lower extremities and
stretching exercises for the lower extremity muscles for a total of about 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.OA of knee confirmed by ACR clinical classification criteria
In this criteria the presence of knee pain along with at least three of the
following six items can classify the knee OA in the patients :
age 50 years onwards
Morning stiffness less than thirty minutes
Crepitus on knee motion
Bony tenderness
Bony enlargement
No palpable warmth
2.Score of two or higher on Kellgren-Lawrence scale18
3. Age- 50 to 70 years
4. Body mass index less than or equal than twenty nine point nine kg/m2
5. The average knee pain during weight-bearing activities of at least four on the VAS
during the previous week
6. A history of pain in one or both knees for at least four months in the year prior to
study enrolment, or four or more days per week.
7. A history of at least four months ‘of knee pain, or four or more days per week, in the
year before study enrolment.
8. Mini-Mental Score more than twenty four
9. Willingness to participate |
|
| ExclusionCriteria |
| Details |
Diagnosis of other systemic rheumatic disease (e.g. RA,)
1. History of metastatic cancer in past three months
2. Diagnosed with psychosis or dementia
3. Serious disease that might restrict participation
4. Patients planned for knee arthroplasty
5. Severe impairment in hearing/speech
6. No access to mobile
7. Patients reporting about pain arising from trauma
8. Currently participating in an aerobic exercise programme
9. Steroid injections in either knee within the previous three months
10. Patients taking steroid |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.visual analogue scale
2 functional performance on
30sec. chair stand test and 40mfast-paced walk test
3.disability using WOMAC |
Baseline and 12 weeks post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.arthritis self-efficacy scale
2.pain catastrophizing scale |
Baseline and 12 weeks post-intervention |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
15/04/2026 |
| 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="3"
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
|
This randomized controlled trial aims to compare the effectiveness of a blended structured education approach combined with neuromuscular exercise versus neuromuscular exercise alone in individuals with musculoskeletal dysfunction Participants will be randomly allocated into two groups the experimental group will receive a structured patient-centred education program delivered through blended modes along with a standardized neuromuscular exercise protocol while the control group will receive the same Neuromuscular exercise program alone Outcomes related to pain physical function Performance and disability will be assessed at baseline and post intervention to determine the additional benefit of integrating structured education with exercise The study is designed to generate evidence on whether a blended education-exercise model provides superior clinical outcomes compared to exercise only rehabilitation |