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CTRI Number  CTRI/2024/01/061646 [Registered on: 19/01/2024] Trial Registered Prospectively
Last Modified On: 14/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the Effect of Intermittent Vacuum Therapy in Patients with Knee Osteoarthritis 
Scientific Title of Study   Efficacy of Intermittent Vacuum Therapy as an Adjunct to Conventional Physiotherapy Treatment in Patients With Knee Osteoarthritis.  
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 Radhika Ramesh Sawal 
Designation  MPT student 
Affiliation  Sunandan Divatia School of Science 
Address  Department of physiotherapy,ground floor, Nanavati Max Superspeciality Hospital SV road, LIC colony, Vile Parle West Sunandan Divatia School of Science, SVKM, Bhakti Vedanta Road, Vile Parle West

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  07218733349  
Fax    
Email  sawalradhikaramesh24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arnaaz Rusi Doctor 
Designation  Assistant professor- physiotherapy 
Affiliation  Sunandan Divatia School of Science 
Address  Sunandan Divatia School of science, SVKM Bhaktivedanta road, Vile parle west

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9930033014  
Fax    
Email  arnaaz.doctor@nmims.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Arnaaz Rusi Doctor 
Designation  Assistant professor- physiotherapy 
Affiliation  Sunandan Divatia School of Science 
Address  Sunandan Divatia School of sciences, SVKM Bhaktivedanta road, Vile parle west

Mumbai
MAHARASHTRA
400056
India 
Phone  9930033014  
Fax    
Email  arnaaz.doctor@nmims.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Ground floor, Nanavati Max Super Speciality Hospital, SV Road, Vile Parle West, bhaktivedanta Road, Mumbai suburban, Maharashtra- 400056 
 
Primary Sponsor  
Name  Dr Radhika Sawal 
Address  Sunandan Divatia school of sciences svkm bhaktivedanta road vile parle west 
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 Radhika Sawal  Nanavati Max Superspeciality Hospital  Department of Physiotherapy, Ground floor Nanavati Max Superspeciality Hospital, Swami Vivekanand road,LIC colony Vile parle west-400056
Mumbai (Suburban)
MAHARASHTRA 
02226172329

sawalradhikaramesh24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee, Dr. Balabhai Nanavati Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Interemittent Vacuum Therapy  10 sessions in 2 weeks 
Comparator Agent  Intermittent vacuum therapy vs conventional therapy  10 sessions protocol 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Known case of Knee Osteoarthritis diagnosed by a physician 
 
ExclusionCriteria 
Details  Recent surgery
Recent known lower limb injuries
Pregnant women
Known circulatory disorders in lower extremities
Associated with any known neurological impairment and cardiovascular conditions 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1)Disability - WOMAC questionnaire
2)Range of Motion- Universal Goniometer
3)Pain- Visual Analog Scale 
At 2 points
At first day of the session pre assessment will be taken
Participants will be given 10 sessions of Intervention
Followed by post assessment will be done at the end of 10th session 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   24/01/2024 
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="6"
Days="0" 
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   TITLE OF THE PROJECT: Efficacy of Intermittent Vacuum Therapy as an Adjunct to Conventional Physiotherapy Treatment in Patients with Knee Osteoarthritis

INTRODUCTION: Osteoarthritis (OA) is a severe joint disease that affects more than 60 percent of the elderly. Primary OA pathogenesis is an intrinsic cartilage disorder in which biomechanical and metabolic changes contribute to its breakdown. Although OA is a phase of multifactorial disease, early cartilage damage, and ultimate loss of articular cartilage are considered essential for OA progression. Another essential pathophysiology of OA is bone or joint deterioration, in addition to cartilage degeneration. Although multiple accounts of joint deformity such as osteophytes, subchondral osteosclerosis, and bone cysts are important pathological hallmarks for OA.  
Given that OA has no cure, and self-management with exercise and physical activity is a core recommended management strategy, physiotherapists are important providers of care. As with all healthcare professionals, physiotherapists are responsible for ensuring that the OA care they provide is safe and aligns with best practice Intermittent vacuum therapy -IVT- was developed by NASA based on the LBNPD procedure (lower body negative pressure device). This kind of therapy is used to treat vascular diseases of the legs, to accelerate rehabilitation of athletes, to reduce edema in the lower extremities, to treat cellulite as well as other indications. The device for intermittent vacuum therapy consists of a cylindrical chamber into which the lower body of a patient is placed. The patient is lying on his back, his legs and lower body up to the crest of the iliac bone are inside the chamber. In the area of the waist, the chamber enclosing the lower body of the patient is sealed using a diaphragm. A vacuum pump generates negative pressure in the chamber. The device generates intermittently negative and normal pressure. Under the effect of the vacuum, blood from the area with relatively high pressure (upper body outside the chamber) flows into the area of lower pressure (lower body inside the chamber), thus improving blood circulation in the lower extremities. Due to the blood flow towards the lower extremities, the mean blood pressure falls. Normally, the body compensates for the redistribution of blood by increasing the pulse rate and peripheral vascular constriction. Due to the blood flow towards the lower extremities, the mean blood pressure falls.

AIM:- To study the comparative effects of IVT & conventional physiotherapy in the management of Knee Osteoarthritis

OBJECTIVES:- 
1. To assess the effects of IVT along with Conventional protocol on a decrease in pain, increase in ROM, and functional activity in Knee Osteoarthritis 
2. To assess the effects of Conventional therapy on the decrease in pain, increase in ROM, and functional activity in Knee Osteoarthritis
3. To compare the effects of both in patients with Knee Osteoarthritis.

 Inclusion criteria: Known Case of Knee Osteoarthritis diagnosed by physician Both male & female

Exclusion criteria: Recent surgery Recent known lower limb injuries Pregnant Women with Known circulatory disorders in lower extremities associated with any known neurological impairment & cardiovascular conditions 

Outcome measures 
1. Disability- WOMAC questionnaire
2. Range of Motion- Universal Goniometer
3. Pain- Visual Analog Scale 
 
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