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临床试验/CTRI/2022/11/047209
CTRI/2022/11/047209尚未招募不适用

A study on the effect of hypertonic dextrose injection in Osteoarthritis knee-A Cohort study

ROHILKHAND MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年11月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
To study the effect of Hypertonic dexxtrose injection in patients with Osteoarthritis knee

研究概览

简要总结

Knee Osteoarthritis is a chronic, progressive and disabling joint disease1. Knee OA is important due to high prevalence of pain and disability that they cause in older adults. It is estimated that over 80% of people over 55years of age have osteoarthritis of at least one joint. Pain origin is from both intra articular as well as extra articular structures2,3 resulting in decreased function of the joint. Conservative management by any single therapy has shown no clear benefit. Standard of care involves multiple disciplines.4

Currently available treatment modalities focus majorly on symptom relief and improvement of joint function rather than modifying the disease progression. There is ongoing research on various disease modifying treatments that regulate cartilage breakdown and formation, modulation of inflammation and subchondral bone remodeling. In recent years, a variety of treatment modalities have been researched upon but these interventions incur considerable costs and have questionable efficacy.5

Modern use of prolotherapy dates back to the 1950s, with increased focus by physicians in 1990s. Hypertonic dextrose therapy is an injection therapy used for chronic musculoskeletal injury, including knee osteoarthritis.6,7 The underlying principle is the injection of small volumes of an irritant solution at multiple tender ligament and tendon insertion sites and in adjacent intra articular joint spaces over several strategically spaced treatment sessions. The irritant solution leads to initiation of a local inflammatory cascade, leading to proliferation of tissue and remodeling of bone and cartilage. Even though exact mechanism of action is unknown but potential mechanisms have been put forth suggesting regeneration and repair of tissue by inciting inflammation by use of irritant solutions. Other proposed mechanisms are increase in PDGF (platelet derived growth factors) and direct acting on pain modulation

Osteoarthritis knee presents a great burden and disability in the elderly population without any standard treatment recommendations with only joint replacement as the definitive management in end stage disease and symptomatic treatment in early stages with no definitive cure. Joint replacement as a definitive treatment presents its own challenges in being expensive, surgical complications, patients with co-morbidities unfit for surgery. Prolotherapy is an emergent non-surgical, effective, affordable therapy suitable for the patients in different stage of disease and those unfit to undergo surgery.

The need for this study arises due to scanty research and underpowered studies in the use of hypertonic dextrose therapy in the treatment of osteoarthritis knee.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 years or more Patients willing to take the injection Patients with diagnosis of knee osteoarthritis based on clinical criteria Patients with radiographic evidence of knee osteoarthiritis.

排除标准

  • patients with BMI>40 pregnancy Uncontrolled diabetes History of total knee replacement Any knee injection in the past 3 months Inflammatory or post infectious knee arthritis Daily use of opioid medication Comorbidity severe enough to prevent participation in the study Patients with local skin condition at injection site.

结局指标

主要结局

To study the effect of Hypertonic dexxtrose injection in patients with Osteoarthritis knee

时间窗: week 5, 9, 12 ,24

次要结局

  • To assess the functional outcome of hypertonic dextrose injection in knee osteoarthritis on the basis of:(1.Composite score of Western Ontario McMaster University Osteoarthritis Index (WOMAC))

研究者

发起方
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL
申办方类型
Private medical college

研究点 (1)

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