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CTRI Number  CTRI/2014/01/004270 [Registered on: 02/01/2014] Trial Registered Retrospectively
Last Modified On: 01/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Physiotherapy (Not Including YOGA)
Behavioral
Other (Specify) [Kinesthesia ,balance ,training and meditation,weight reduction]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Trial of 2 conservative therapies for knee arthritis patients  
Scientific Title of Study   Comparative impact of two packages of non pharmacological interventions on quality of life of knee osteoarthritis patients reporting at a tertiary care institution - A randomized control trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenakshi 
Designation  PhD student 
Affiliation  PGIMER 
Address  School of Public Health PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  mnxmph@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amarjeet Singh 
Designation  Professor 
Affiliation  PGIMER 
Address  School of Public Health PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  amarminhas56@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Meenakshi 
Designation  PhD student 
Affiliation   
Address  School of Public Health PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  mnxmph@gmail.com  
 
Source of Monetary or Material Support  
not applicable 
 
Primary Sponsor  
Name  not applicable 
Address  not applicable 
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 
Dr Meenakshi  ORTHOPAEDICS OPD PGIMER CHANDIGARH  ORTHOPAEDICS and PRM DEPARTMENT Room number 1003,New OPD PGIMER
Chandigarh
CHANDIGARH 		 9463595993

MNXMPH@GMAIL.COM 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  mild and moderate grade of Knee osteoarthritis ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group B  Same as Intervention group; however KBA session and meditation are not part of this group 
Intervention  The diagnosed KOA (Knee osteoarthritis) patients who consult PGI Chandigarh during study period will be assigned to group A   An introductory session will be held by the researcher on the first visit of KOA patient. It is expected to last for about 5-10 minutes. All the patients in both the groups will be given a self instruction manual (SIM) containing all information about various components of the proposed intervention package. Intervention package components: a) Physiotherapy :This session will include training of patients on a set of exercises by the researcher with the help of physiotherapist (duration -10 minutes).It will be held in Physical and Rehabilitation Medicine (PRM) department. b) Short wave diathermy The KOA patients included in the study will receive SWD as per the instructions of the concerned clinician. Protocol of PRM department will be followed for SWD application. c) Kinesthesia, Balance and Agility training (KBA) Session for KBA will be conducted in a separate room for the group ‘A’ only. It is expected to be of 20 minutes duration. Separate handouts will be given for this. d) Meditation This session will also be conducted by researcher in group ‘A’ only. It is expected to last for 10 minutes. Patients will be guided to focus attention on the breathing and on how the body moves with each inhalation and exhalation. For conducting meditation sessions the researcher will obtain the requisite training. e) Weight reduction Height and weight of the patient will be measured using standard techniques.BMI will be calculated on first visit of the patients. Participants with BMI ≥25 at baseline will be advised on weight reduction. The patients will be explained about the goal of the intervention (reduction in body weight by at least 5 % and retention of this throughout) and about the need of weight reduction. Appropriate dietary advice will be given. The diet charts will be provided to patients .During follow up visits participants will be regularly motivated by researcher to comply with the dietary advice.The patients will be explained regarding follow up visits.There will be 26 follow up visits per patient at the interval of 0,3,7,14,21 days from the day of enrollment.Then, once a week for next 2 months (Visit 6-13),once in fortnight for next 4 months(Visit 14-21),once a month for next 4 months (Visit 22-25)and final visit will be at the end of 1 year(26th visit).  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Self-reported knee pain
2.Radiological /clinical grade 1, 2, 3 as per Kellgren Lawrence scale (table - ) certified by clinician.
3.Demonstrated minimal knee OA related dysfunction as per WOMAC score
4.Motivated and willing to alter their lifestyle and able to comply with the planned schedule for follow up
 
 
ExclusionCriteria 
Details  1.Candidates for surgery due to deformity or intra –articular pathology
2.Excessive obesity (BMI>40)or any co-morbidity not allowing proper exercise protocol
3.Unresolved balance disorder
4.Unresolved neurological disorder
5.History of knee surgery or knee trauma
6.Hip or ankle instability, excessive weakness
7.Hip or knee replacement
8.Intra-articular joint injection within 4 weeks of the study
9.Inadequate communication skills in Hindi /Punjabi
10.Illiterate (nor have any literate caregivers)
11.Unable to comply with exercise protocol.
Participants will also be excluded if they have a significant medical condition that will increase their risk of a significant adverse health event during physical activity (eg, myocardial infarction in the previous 6 months, abnormal blood pressure response to exercise, etc.); have any other known organic disease that would contraindicate safe participation in the study (eg, cancer); have a non-OA inflammatory arthropathy or another arthritic disorder (eg, rheumatoid arthritis); use oral corticosteroids regularly.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Quality of life
• Measure of function
• Visual analogue scale
• 50-Foot Timed Walk,
• 30-second Chair Stand Test
• Timed up and go test
• BMI 		 visit 0- visit 26 
 
Secondary Outcome  
Outcome  TimePoints 
1.Difficulties faced by participants in complying with the intervention package.
2.Impact of KOA on daily routine, treatment taken by different agencies 		 visit 0- visit 26 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "123"
Final Enrollment numbers achieved (India)="123" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/10/2013 
Date of Study Completion (India) 02/02/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 

Knee osteoarthritis (KOA) is one of the common cause of disability after fourth decade of life. In India, its prevalence has been reported to be in the range of 17-61% among people aged above 50 years. Intractable pain is the most common symptom of KOA. Quality of life (QOL) of KOA patients significantly deteriorates with pain and loss of mobility causing dependence and disability. There is no permanent cure for KOA. However, long-term effects of early to moderate KOA can be managed through non surgical interventions. This includes use of non-pharmacological interventions (NPIs) comprising of patient education, a set of exercises and weight reduction etc. These are often used in conjunction with a pharmacological regimen.

In contrast to the situation in western countries, where research has been regularly conducted to evaluate the relative impact of combining a variety of non pharmacological interventions on KOA, there has not been any systematic effort in India on these lines.

Objectives:

Primary:

 i)       To compare the impact of two non pharmacological intervention packages on quality of life in KOA patients reporting at PGIMER Chandigarh.

Secondary:

 i)           To enlist and compare the components of various NPIs being prescribed to KOA patients in India.

ii)            To explore the opinion of clinicians regarding the potential effectiveness of various NPIs being used for KOA patients including that of the package developed for this study

iii)           To document the difficulties/problems faced by KOA patients in complying with the instructions pertaining to the NPIs given in the hospital.

 

 
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