| 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
|
|
|
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
|
|
|
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 OsteoarthritisINTRODUCTION: 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 |