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临床试验/CTRI/2023/10/058599
CTRI/2023/10/058599尚未招募2 期

Effects of magnesium in physiotherapy treatment for patients with knee osteoarthritis

Dr Khadija Lokhandwala1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月16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
40
试验地点
1
主要终点
1)Visual Analog Scale (VAS)- On Rest

研究概览

简要总结

TITLE OF THE STUDY-

Effects of magnesium in physiotherapy treatment for patients with knee osteoarthritis

INTRODUCTION-

Osteoarthritis is a complex joint disorder characterized by articular cartilage degradation, abnormal mineralization and inflammation. Knee osteoarthritis predominantly affecting the medial tibiofemoral compartment, is a major public health problem. Magnesium deficiency is considered to be a major risk factor for osteoarthritis development and progression. Magnesium deficiency is active in several pathways that have been implicated in osteoarthritis, including increased inflammatory mediators, cartilage damage, defective chondrocyte biosynthesis, aberrant calcification and a weakened effect of analgesics. Oral magnesium presents unique challenges for many individuals to effectively restore intracellular magnesium levels. To completely comprehend the possible advantages of magnesium for osteoarthritis, more research is nonetheless required. Hence this study will be conducted to provide further data on the effect of transdermal magnesium (through topical application of magnesium oil and immersion in Epsom salt foot soak) on patients with knee osteoarthritis.

AIM -

To determine the therapeutic effects of Magnesium in physiotherapy treatment for patients with knee osteoarthritis.

 OBJECTIVE -

1.      To assess the effects of conventional therapy in osteoarthritis on pain and functional mobility. 2.      To assess the effects of Magnesium as an adjunct to conventional therapy in osteoarthritis. 3.      Comparison of the above two groups.

Inclusion Criteria-

  1. Subjects diagnosed with knee osteoarthritis
  2. Age group 40-70 years

Exclusion Criteria-

1.     Subjects with other known musculoskeletal conditions of knee 2.     Having other joint pathologies (for example, rheumatoid arthritis, severe osteoporosis, or fracture) 3.     Uncontrolled blood pressure,diabetes mellitusor suspected diseases that may restrict exercise

OUTCOME MEASURES-

1.     Pain assessment

a)     Visual Analog Scale (VAS)

On Rest

On Activity

2.     Functional Mobility assessment a)     Western Ontario and McMaster Universities Arthritis Index (WOMAC)  b)    Timed up and go test (TUG) c)     Stair Climb Test

PROCEDURE-

·    ·       Aninterventional study will be conducted after seeking approval of the ethicalcommittee. ·       Registrationwill be done with CTRI. ·       Thesubjects will be selected according to the inclusion and exclusion criteria. ·       Subjectswill be explained about the study and an informed consent will be filled bythem who satisfy the inclusion criteria. ·      Simplerandom sampling of subjects into two groups and outcome measures assessed. ·      GroupA- Conventionaltherapy + Warm water foot soak ·      GroupB- Conventionaltherapy + Epsom salt foot soak + Magnesium oil application ·      Intervention of 8 sessions will be given, outcome measures repeatedpost completion of intervention period and data analysis will be done**.**

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

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

入选标准

  • Diagnosed case of Knee Osteoarthritis.

排除标准

  • 1.Subjects with other known musculoskeletal conditions of knee 2.Having other joint pathologies (for example, rheumatoid arthritis, severe osteoporosis, or fracture) 3.Uncontrolled blood pressure, diabetes mellitus or suspected diseases that may restrict exercise.

结局指标

主要结局

1)Visual Analog Scale (VAS)- On Rest

时间窗: Pre intervention before the first session and post intervention after the eight session

5)Stair Climb Test

时间窗: Pre intervention before the first session and post intervention after the eight session

2)Visual Analog Scale (VAS)- On Activity

时间窗: Pre intervention before the first session and post intervention after the eight session

3)Western Ontario and McMaster Universities Arthritis Index (WOMAC)

时间窗: Pre intervention before the first session and post intervention after the eight session

4)Timed up and go test (TUG)

时间窗: Pre intervention before the first session and post intervention after the eight session

次要结局

  • 1)Quadriceps strength(2)Knee Range of motion)

研究者

发起方
Dr Khadija Lokhandwala
申办方类型
Other [self]

研究点 (1)

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