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CTRI Number  CTRI/2025/02/081419 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain Education Module for Patients with Chronic Knee Osteoarthrtitis.  
Scientific Title of Study   Development, Validation and Implementation of Pain education module in patients with chronic knee osteoarthritis: A mixed method 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  Dr Chhaya V Verma  
Designation  Professor and HOD 
Affiliation  P.T. School and Centre TNMC and BYL Nair Hospital, Mumbai 
Address  Dr. A.L, Dr. Anandrao Nair Marg, Mumbai Central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone    
Fax    
Email  cvverma100@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jui V Bane PT 
Designation  Assistant Professor 
Affiliation  The SIA College of Health Sciences, College of Physiotherapy, Dombivli. 
Address  The SIA College premises, P88, MIDC residential area, Dombivli gymkhana road, sagarli, Dombivli east.

Thane
MAHARASHTRA
421203
India 
Phone  9619640661  
Fax    
Email  juibane13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jui V Bane PT 
Designation  Assistant Professor 
Affiliation  The SIA College of Health Sciences, College of Physiotherapy, Dombivli. 
Address  The SIA College premises, P88, MIDC residential area, Dombivli gymkhana road, sagarli, Dombivli east.

Thane
MAHARASHTRA
421203
India 
Phone  9619640661  
Fax    
Email  juibane13@gmail.com  
 
Source of Monetary or Material Support  
The SIA College of Health Sciences, College of Physiotherapy, Dombivli. The SIA College Premises, P-88, MIDC Residential Area, Dombivli Gymkhana Road, Sagarli, Dombivli (East) Dist. Thane Pin 421 203. 
 
Primary Sponsor  
Name  None 
Address  N.A 
Type of Sponsor  Other [N.A] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jui V Bane PT  The SIA College of Health Sciences, College of Physiotherapy, Dombivli.   The SIA College premises, P88, MIDC residential area, Dombivli gymkhana road, sagarli, Dombivli east.
Thane
MAHARASHTRA 		 9619640661

juibane13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP)  Approved 
Research Advisory Committee   Approved 
Scientific Review Committee of The SIA College of Health Sciences, College of Physiotherapy  Approved 
SIA_IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pain Education Module   The Pain education module developed in the form of Multimedia content will be shown to the patients of chronic knee osteoarthritis. The intervention will be given for 6 weeks with 3 sessions per week. Along with the intervention, the standardised physiotherapy exercises will also be given to this group.  
Comparator Agent  Standardised Physiotherapy Exercises  The standardised guidelines given for physiotherapy exercise will be given to the patients of chronic knee osteoarthritis. The exercises will be given for 6 weeks with 3 sessions per week.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with Tibio-femoral or patellofemoral arthritis
2. Patients with symptoms lasting for at least 3 months.
3. Patients fitting in the American College of Rheumatology criteria for knee osteoarthritis.
4. Patients having a score of more than or equal to 4 on 10 on Numerical pain rating scale
5. Patients with grade 1 to 3 of kellgren lawrece scale of radiological severity of knee osteoarthritis.  
 
ExclusionCriteria 
Details  1. Patients with any recent trauma or fractures or soft tissue injuries
2. Patients with other rheumatological, infectious or systemic conditions giving rise to Knee pain.
3. Patients with past history of knee surgeries.
4. Patients with any known cognitive deficits or neurological disorders.
5. Patients having a pain score of more than or equal to 8 on 10 on Numerical Pain Rating Scale.
6. Patients who are referred for total knee replacement  
 
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 
Numerical Pain Rating Scale (NPRS)   0 weeks and 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Pain Catastrophizing Scale   0 weeks and 6 weeks  
Tampa scale of Kinesiophobia   0 weeks and 6 weeks 
Knee Osteoarthritis Outcome score (KOOS)  0 weeks and 6 weeks 
Timed-up-go test  0 weeks and 6 weeks 
Knee Osteoarthritis Fears and Beliefs Questionnaire (KOFBeQ)  0 weeks and 6 weeks 
Pain algometry   0 weeks and 6 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   03/03/2025 
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="3"
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  

Osteoarthritis (OA) is the most prevalent type of musculoskeletal disorder globally and is also the leading cause of chronic pain and disability in adults.Pain is the main symptom of Osteoarthritis of knee, whether it is uni-compartmental, bi-compartmental or tri-compartmental which has debilitating effects on activities, function and in general on the overall Quality of Life of patients. 

In this sense, the pain in knee OA (uni-compartmental, bi-compartmental or tri-compartmental) fits well with the biopsychosocial model, of the ICF, which reflects the influence of biological, psychological and social factors in the individual’s symptoms and suffering. The management of pain in knee OA should take all these factors into consideration. The purpose of doing this study is to develop, validate and implement a Pain education module for patients with chronic knee osteoarthritis. The developed module will be in the form of multimedia content whicch will be used educate the patients with chronic knee osteoarthritis. 

The core idea behind the development of a Pain education module for patient with knee osteoarthritis, is that to the best of our knowledge no module in any form is available only for knee osteoarthritis. And more so for the Asian or specifically for the Indian population. As the lifestyle of Indians is different as compared to the western countries, as also, the cultural differences, religion has an important impact on pain.

We want to assess the effectiveness of the pain education module along with standardised physiotherapy care on pain, catastrophisation, kinesiophobia, knee function and beliefs regarding knee osteoarthrtis in patients with chronic knee osteoathritis. 

 
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