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CTRI Number  CTRI/2025/07/090866 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 29/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Qualitative Research 
Study Design  Other 
Public Title of Study   Quality indicators in patients with Knee osteoarthritis during Physiotherapy in India 
Scientific Title of Study   Perception, Experiences, Facilitators, and Inhibitors in Patients with Knee Osteoarthritis during Physiotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B Chandra 
Designation  Research Scholar 
Affiliation  Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), Mangalore 
Address  Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), Naringana, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  6381531815  
Fax    
Email  25736@yenepoya.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Asir John Samuel 
Designation  Additional Professor 
Affiliation  Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), Mangalore 
Address  Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8059930222  
Fax    
Email  asirjohnsamuel@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  B Chandra 
Designation  Research Scholar 
Affiliation  Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), Mangalore 
Address  Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), Mangalore.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  6381531815  
Fax    
Email  25736@yenepoya.edu.in  
 
Source of Monetary or Material Support  
B. Chandra, Research Scholar, Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), Mangalore, 575018, Karnataka, India 
 
Primary Sponsor  
Name  B Chandra 
Address  Research Scholar, Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), Mangalore, 575018, Karnataka, India. 
Type of Sponsor  Other [Self] 
 
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 Asir John Samuel  Yenepoya Medical College Hospital, Yenepoya (Deemed to be University).  7th floor, Physiotherapy Department, Room No. 1, University Road, Deralakatte, Mangalore- 575018
Dakshina Kannada
KARNATAKA 		 6381531815

25736@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Yenepoya Ethics Committee 2  Approved 
Yenepoya Ethics Committee 2  Approved 
Yenepoya Ethics Committee 2  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  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with knee osteoarthritis (KL grades 1-4)
All genders
Age 40 years & above (NICE GUIDELINES)
Patients undergoing physiotherapy treatment for knee osteoarthritis
Both unilateral and bilateral Knee osteoarthritis 
 
ExclusionCriteria 
Details  Infectious conditions of the knee
Inflammatory arthritis
Other musculoskeletal disorders
Cognitive deterioration and severe mental disease
Uncontrollable diabetes mellitus resulting in severe mobility
impairment
Patients had a history of spine, abdomen, and lower limb surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Understanding perceptions, experiences, and factors that will facilitate and inhibit the physiotherapy treatment of patients with knee osteoarthritis.   Once 
 
Secondary Outcome  
Outcome  TimePoints 
Pain alleviation  Once 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/07/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 (Others) -  Anonymized data of the study participants, such as demographic, socioeconomic, disease-related data, and the interview transcription; hence it is a qualitative study

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response (Others) -  To increase the transparency of the research, the individual participant data will be published in the online dataset.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be pulished into the online dataset in future

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 02-07-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
Knee osteoarthritis (OA) is a chronic degenerative disease that impacts the joints and cartilage throughout the body. OA is a persistent medical illness that impacts the joints, reducing mobility and diminishing the standard of life in older individuals. Patients may face difficulties due to a lack of understanding and a support system while treating, especially in physiotherapy management for knee osteoarthritis. So, the study aims to explore the perception, and experiences of the disease and physiotherapy treatment and identify the facilitators and inhibitors of treatment adherence. Participants will be recruited to the study using a purposive sampling technique. This study will be conducted through semi-structured interviews which adopt open-ended questions. In-depth interviews will be one-to-one. Based on patients’ flexibility and feasibility, the interview will be conducted face-to-face, Telephone, or videoconferencing in Google Meet. The interview will be recorded using a digital audio recorder. Recorded data will be transcribed verbatim. Data will be analyzed using thematic analysis based on Braun and Clark’s 2006 approach for Kellgren and Lawrence grade (1-4) of knee osteoarthritis.
 
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