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CTRI Number  CTRI/2024/08/072772 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 19/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [CONTRAST HYDRO THERAPY]  
Study Design  Other 
Public Title of Study   A clinical trial to study the effectiveness of nurse led intervention on pain, stiffness and physical function among patients with osteoarthritis 
Scientific Title of Study   Effectiveness of nurse led intervention on pain, stiffness and physical function among patients with lower limb osteoarthritis at a tertiary care center in Alappuzha. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ASWATHY R 
Designation  MSc Nursing Student 
Affiliation  KUHS, KERALA 
Address  2nd year MSc Nursing student Department of Medical surgical Nursing, Room No. 2, 2nd floor , Govt. college of nursing, Vandanam (po), Alappuzha, Alappuzha, Kerala

Kollam
KERALA
688005
India 
Phone  9656744565  
Fax    
Email  aswathyramachandran94@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Remya Raveendran V 
Designation  Assistant Professor 
Affiliation  KUHS, KERALA 
Address  Department of Medical Surgical Nursing, Ground floor, Govt. College of Nursing, Vandanam p.o ,Alappuzha

Alappuzha
KERALA
688005
India 
Phone  9946942749  
Fax    
Email  remmukailasam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aswathy R 
Designation  MSc Nursing Student 
Affiliation  KUHS, KERALA 
Address  Department of Medical Surgical Nursing, 2nd floor, Govt. College Of Nursing, Alappuzha

Alappuzha
KERALA
688005
India 
Phone  9656744565  
Fax    
Email  aswathyramachandran94@gmail.com  
 
Source of Monetary or Material Support  
Govt. T D Medical College Hospital, Alappuzha 
 
Primary Sponsor  
Name  ASWATHY R 
Address  PLAVILATHEKKATHIL,KUTHIRAPANTHY PO,THAZHAV,KARUNAGAPPALLY:690523 
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 
ASWATHY R  GOVT. T D MEDICAL COLLEGE HOSPITAL,  DEPARTMENT OF ORTHOPEDICS, ROOM NO. 1 ,GROUND FLOOR,
Alappuzha
KERALA 		 9656744565

aswathyramachandran94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, GOVT. COLLEGE OF NURSING ALAPPUZHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M190||Primary osteoarthritis of other joints,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Structured educational programme,Contrast hydrotherapy, Exercises  The contrast hydrotherapy implemented by giving warm and cold compresses using a towel that has been soaked in hot water (40-45ËšC) and cold water(10-15ËšC) alternately in the pain area with a compress ratio of 3:1 minute (warm compress for 15 seconds and cold compress for 5 seconds) for repetition of 20 times daily (ten times morning and ten times evening) for 30 days. ISOMETRIC EXERCISES 1. Quadriceps set Patient is made to lie on the bed with legs extended. A rolled hard towel in placed under the knee and the patient is asked to compress the towel and also count up to 5 in mind. Then come to previous position. Do it for 10 times morning and evening for 30 days. 2. Hamstring stretch This exercise is intended to strengthen the Hamstring muscles at the back of the thighs. Sit on bed with straight legs and try to touch the toe with fingers. Do it for 10 times morning and evening for 30 days. 3. Straight leg raise Patient is asked to lie supine. Then to raise the leg which has pain without flexing the knee to about 45° and count up to 5 and then come back to normal position. Do it for 10 times morning and evening for 30 days. If there is pain on both legs, do it alternately on both legs.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with radiological evidence of primary lower limb osteoarthritis of grade 1,2 and 3 on Kellgren Lawrence scale for 1 to 6months
who are willing to participate in the study,
who are within the age group of 45-70 years.
who are able to do isometric exercises.
 
 
ExclusionCriteria 
Details  who have a history of malignancy of any site.
who have major psychiatric disorders.
who are posted for joint replacement surgery.
who are currently on physiotherapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
WOMAC OSTEOARTHRITIS INDEX SCORE (MODIFIED CRD PUNE VERSION)  6MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
WOMAC OSTEOARTHRITIS INDEX SCORE(MODIFIED CRD PUNE VERSION)
PAIN, STIFFNESS AND PHYSICAL FUNCTION 		 31st DAY 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   30/08/2024 
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="0"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Statement of the problem

Effectiveness of nurse led intervention on pain, stiffness and physical function among patients with lower limb osteoarthritis.

Objectives

1.     Evaluate the effectiveness of nurse led intervention on pain among patients with lower limb osteoarthritis.

2.     Evaluate the effectiveness of nurse led intervention on stiffness among patients with lower limb osteoarthritis.

3.     Evaluate the effectiveness of nurse led intervention on physical function among patients with lower limb osteoarthritis. 

Hypotheses

H1: There is a significant difference in the mean scores of pain among patients with lower limb osteoarthritis between control group and experimental group.

H2: There is a significant difference in the mean scores of stiffness among patients with lower limb osteoarthritis between control group and experimental group.

H3: There is a significant difference in mean scores of physical functions among patients with lower limb osteoarthritis between control group and experimental group.

 
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