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临床试验/CTRI/2024/01/061646
CTRI/2024/01/061646尚未招募2 期

Efficacy of Intermittent Vacuum Therapy as an Adjunct to Conventional Physiotherapy Treatment in Patients With Knee Osteoarthritis.

Dr Radhika Sawal1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月24日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1)Disability - WOMAC questionnaire

研究概览

简要总结

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

研究设计

研究类型
Interventional

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Known case of Knee Osteoarthritis diagnosed by a physician.

排除标准

  • Recent surgery Recent known lower limb injuries Pregnant women Known circulatory disorders in lower extremities Associated with any known neurological impairment and cardiovascular conditions.

结局指标

主要结局

1)Disability - WOMAC questionnaire

时间窗: 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

2)Range of Motion- Universal Goniometer

时间窗: 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

3)Pain- Visual Analog Scale

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Dr Radhika Sawal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Radhika Ramesh Sawal

Sunandan Divatia School of Science

研究点 (1)

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