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CTRI Number  CTRI/2023/05/053101 [Registered on: 24/05/2023] Trial Registered Prospectively
Last Modified On: 23/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   EFFECT OF PAIN EDUCATION AND COGNITION TARGETED EXERCISES ON PAIN, DISABILITY AND QUALITY OF LIFE IN KNEE OSTEOARTHRITIS PATIENTS 
Scientific Title of Study   EFFECT OF PAIN NEUROSCIENCE EDUCATION COMBINED WITH COGNITION TARGETED EXERCISES ON PAIN, KINESIOPHOBIA, DISABILITY AND QUALITY OF LIFE IN KNEE OSTEOARTHRITIS PATIENTS : AN OPEN-LABEL RANDOMIZED CONTROLLED TRIAL. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vrushali Panhale 
Designation  Professor 
Affiliation  MGM College of Physiotherapy 
Address  MGM College of Physiotherapy, First floor,Plot-46, Sector 30 A, Vashi, Navi Mumbai Thane MAHARASHTRA 400705 India

Thane
MAHARASHTRA
400705
India 
Phone    
Fax    
Email  vrushali.d@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prachita Walankar 
Designation  Associate Professor 
Affiliation  MGM College of Physiotherapy 
Address  MGM College of Physiotherapy, First floor,Plot-46, Sector 30 A, Vashi, Navi Mumbai Thane MAHARASHTRA 400705 India

Thane
MAHARASHTRA
400705
India 
Phone    
Fax    
Email  prachita30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Raj Mhatre 
Designation  MPT Scholar 
Affiliation  MGM College of Physiotherapy 
Address  MGM College of Physiotherapy, First floor,Plot-46, Sector 30 A, Vashi, Navi Mumbai Thane MAHARASHTRA 400705 India

Thane
MAHARASHTRA
400705
India 
Phone    
Fax    
Email  rajmhatre0914@gmail.com  
 
Source of Monetary or Material Support  
MGM College of Physiotherapy, Plot no 46, Sector 30 A, Vashi-400705, Navi Mumbai  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
Raj Mhatre  MGM Hospital  Room 3, 2nd floor, Musculoskeletal Physiotherapy OPD division, Department of Physiotherapy, Plot No. 1 & 2, Sector-1, NH-4 Junction, Mumbai - Pune Hwy, Kamothe, Navi Mumbai, Maharashtra 410209 Raigarh MAHARASHTRA
Raigarh
MAHARASHTRA 		 9768464728

rajmhatre0914@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MGM Dental College and Hospital   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 
Comparator Agent  Conventional Exercises  Knee range of motion exercises Strengthening exercises Session will be given thrice a week for four weeks 
Intervention  PAIN NEUROSCIENCE EDUCATION COMBINED WITH COGNITION TARGETED EXERCISES   Pain neuroscience education Cognition targeted exercises Session will be given thrice a week for four weeks  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants fitting in the American College of Rheumatology criteria for knee osteoarthritis. 
 
ExclusionCriteria 
Details  Participants Fractures at lower limb, pelvis and spine.
Participants with soft tissue injuries around the knee.
Participants with patella pathology.
Participants with history of knee surgeries.
Participants diagnosed with neurological, cardio-respiratory or psychiatric involvement.
Participants with spinal surgeries and radiculopathies.
Participants with malignancy.
Participants not willing to take part in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Numerical Rating Scale
Pain Catastrophizing Scale
Tampa Scale of Kinesiophobia
WESTERN ONTARIO AND MCMASTER UNIVERSITIES ARTHRITIS INDEX (WOMAC)
SF-36 		 Pre intervention and Post Intervention after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   06/06/2023 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  To contact the investigator on this mail id : vrushali.d@rediffmail.com

  6. For how long will this data be available start date provided 01-02-2024 and end date provided 02-02-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Osteoarthritis (OA) of knee is a prevalent and disabling condition that imposes a remarkable burden, with notable implications for the individuals affected, healthcare systems and wider socioeconomic costs. Chronic  pain  is  incredibly  complex,  and  so  are  decisions  as to  its treatment. During physical therapy care PNE aims to help patients understand more about their pain from a biological and physiological perspective. For chronic musculoskeletal pain disorders, there is compelling evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophization, and physical performance. There are previous studies which suggested that PNE is effective in improving pain, kinesiophobia, quality of life in patients with chronic musculoskeletal pain. PNE has been found to be effective in reduction of pain but there is lack of research about PNE combined with cognition targeted exercises on pain, kinesiophobia and disability in knee osteoarthritis patients.

 

 
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