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CTRI Number  CTRI/2025/01/078905 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   cold therapy for osteoarthritis of knee 
Scientific Title of Study   Evaluate the effect of cold knee pack on pain pressure threshold and range of motion in knee osteoarthritis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Narmatha M 
Designation  PG SCHOLAR 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  Department of naturopathy, Ground floor, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  8098284017  
Fax    
Email  narmatham98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pandiaraja M 
Designation  Assistant Medical Officer/ Grade II Lecturer 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  Department of naturopathy, Ground floor, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9952448729  
Fax    
Email  drpandiarajamuthupandimd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pandiaraja M 
Designation  Assistant Medical Officer/ Grade II Lecturer 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  Department of naturopathy, Ground floor, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9952448729  
Fax    
Email  drpandiarajamuthupandimd@gmail.com  
 
Source of Monetary or Material Support  
Outpatient and Inpatient Department,International Institute of Yoga and Naturopathy Medical Sciences, Kamarajar nagar, Thirumani Road, Chengalpattu-603001. 
 
Primary Sponsor  
Name  Dr Narmatha M 
Address  Postgraduate, Department of Naturopathy, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu 603001 
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 Narmatha M  International Institute of Yoga and Naturopathy medical sciences  Ground floor, Department of Naturopathy.
Kancheepuram
TAMIL NADU 		 8098284017

narmatham98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
International Institute of Yoga and Naturopathy Medical Sciences Institutional Ethics Committee  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  Specific yoga and naturopathy protocol  Specific yoga and naturopathy protocols have been given as intervention group without cold knee pack 
Intervention  specific yoga and naturopathy protocol along with cold knee pack  cold knee pack comprises a 5-feet-long, 4-inch-wide white cotton cloth dipped in cold water (55º to 65º F), wrapped around the knee, and then covered with a similarly sized woollen cloth for 20 minutes.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Experiencing mild to moderate knee pain.
Able to provide informed consent.
 
 
ExclusionCriteria 
Details  Recent knee surgery within six months, Use of other treatments for knee osteoarthritis during the study period, Conditions contraindicating cold therapy, Presence of open wounds, skin infections, or dermatological conditions on the knee, Neurological disorders affecting sensory perception, Rheumatoid arthritis and Gouty arthritis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain Pressure Threshold (PPT) will be measured by using an Algometer at the medial aspect of the patient’s affected knee   baseline and after three weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Pain and Range of Motion (ROM) in knee osteoarthritis using a Visual analogue scale (VAS), and Goniometer before and after the intervention  Baseline and after three weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   01/02/2025 
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="1"
Days="1" 
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 - NO
Brief Summary   Osteoarthritis (OA) is a chronic, progressive joint disorder characterized by cartilage degeneration, pain, stiffness, and functional limitations, predominantly affecting weight-bearing joints such as the knees. It is influenced by factors like aging, obesity, joint trauma, and repetitive use, with knee OA being particularly prevalent among the elderly and women. Cold therapy, especially cold knee packs, offers a non-invasive treatment option with physiological effects, including reduced nerve conductivity, inflammation, and pain, as well as improved pain thresholds and joint mobility. However, despite its widespread use, there is limited scientific evidence quantifying its benefits. This study aims to address this gap through a randomized controlled trial involving 60 participants aged 40–75 years with knee OA. The study group will receive yoga and naturopathy interventions combined with a cold knee pack, while the control group will receive only yoga and naturopathy. Pain Pressure Threshold (PPT), assessed with a Biotronix Digital Pressure Algometer, will serve as the primary outcome, while pain intensity and Range of Motion (ROM), evaluated using the Visual Analogue Scale (VAS) and a goniometer, respectively, will be secondary outcomes. Statistical analysis will determine the efficacy of cold knee packs in improving PPT, pain, and ROM in individuals with knee OA. 
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