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CTRI Number  CTRI/2024/04/066335 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Process of Care Changes
Behavioral 
Study Design  Other 
Public Title of Study   Does thermotherapy lead to decreased analgesic requirement in patients with osteoarthritis of knee managed non-surgically. 
Scientific Title of Study   Does thermotherapy lead to decreased analgesic requirement in patients with osteoarthritis of knee managed non-surgically. 
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 Abhishek Kumar Mishra 
Designation  Assistant Professor 
Affiliation  AIIMS,Rajkot 
Address  Room no 1,IPD Building,Department Of Orthopaedics,AIIMS,Rajkot

Rajkot
GUJARAT
360110
India 
Phone  9540230589  
Fax    
Email  akm0009@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhishek Kumar Mishra 
Designation  Assistant Professor 
Affiliation  AIIMS,Rajkot 
Address  Room no 1,IPD Building,Department Of Orthopaedics,AIIMS,Rajkot

Rajkot
GUJARAT
360110
India 
Phone  9540230589  
Fax    
Email  akm0009@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhishek Kumar Mishra 
Designation  Assistant Professor 
Affiliation  AIIMS,Rajkot 
Address  Room no1,IPD Building,Department Of Orthopaedics,AIIMS,Rajkot

Rajkot
GUJARAT
360110
India 
Phone  9540230589  
Fax    
Email  akm0009@gmail.com  
 
Source of Monetary or Material Support  
AIIMS,Rajkot,Gujarat-360110 
 
Primary Sponsor  
Name  AIIMSRajkotGujarat 
Address  AIIMSRajkotGujarat-360110 
Type of Sponsor  Government medical college 
 
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 Abhishek Kumar Mishra  AIIMS Rajkot, Rajkot  Room No-1,IPD Building,AIIMS Rajkot,Gujarat-360110.
Rajkot
GUJARAT 		 9540230589

akm0009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Rajkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NSAID + Physiotherapy  - NSAID with physiotherapy will be used as primary modality for pain relief in Osteoarthritis of the knee 
Intervention  Thermotherapy + NSAID + Physiotherapy  - Hot/Cold application 3times a day 15 minutes each session along with physiotherapy as primary modality for pain relief in Osteoarthritis of the knee - NSAIDs for breakthrough pain 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  -The patient with Knee pain of at least 6 months duration
- THe patients having Primary Osteoarthritis of knee(Kellgren Lawrence Grade 1,2,3,4)
-The patients with Weight bearing X-rays of the knee showing OA knee
- Full ambulant patients
- Patients opting for conservative management of OA knee 
 
ExclusionCriteria 
Details  - The Patients with Infective pathology.
- The patients having Focal chondral defects.
- The patients with Post traumatic Osteoarthritis
- Those who are having Degenerative subluxation of the Knee joint
- Patient shaving Ligamentous instability
- Inflammatory arthritis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
- WOMAC score
- IKDC score 		 3,6,9 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
VAS score  12 months 
 
Target Sample Size   Total Sample Size="312"
Sample Size from India="312" 
Final Enrollment numbers achieved (Total)= "312"
Final Enrollment numbers achieved (India)="312" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/05/2024 
Date of Study Completion (India) 20/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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 - 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
    Response - Clinical Study Report
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [akm0009@gmail.com].

  6. For how long will this data be available start date provided 01-05-2025 and end date provided 31-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Osteoarthritis knee constitutes one the most common ailments presenting to orthopaedic OPD and society in general. NSAIDs constitute the mainstay of treatment and can relieve pain effectively, but they  also have side effects. The risk of side effects depends on age and comorbidity patient may have. People who already have other illnesses, like renal,hepatic and gastrointestinal diseases, may not tolerate them well. Drug interaction is also a challenge in using NSAIDs. Thermotherapy(cold and heat) has shown effectiveness in relieving pain and discomfort of knee osteoarthritis.  In contrast to NSAIDs, no adverse effects of the thermotherapy were reported in the literature. No consideration of drug interaction and no optimization in view of comorbidity is needed.However standardized and scientific study to prove this fact is lacking.A well designed two arm study comparaing NSAIDs and thermotherapy group will be helpful in giving more insight on this issue and making thermotherapy a standard treatment modality of degenerative knee disease. 
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