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临床试验/NCT03460691
NCT03460691Unknown不适用

Investigation of the Effect of Bariatric Surgery on Knee Pain, Disability, Quality of Life and Central Sensitization

Bursa Yüksek İhtisas Education and Research Hospital0 个研究点目标入组 50 人开始时间: 2018年3月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
numeric rating scale (NRS)

研究概览

简要总结

Nowadays obesity is emerging as a very common health problem. It has been shown in various studies that obesity may be an important risk factor for the onset and progression of knee osteoarthritis (OA). The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

详细描述

Weight loss in patients with knee OA reduces pain and provides functional improvement. It has been shown that bariatric surgery combined with diet and exercise changes have positive effects on weight loss, knee pain and function.

Neuropathic pain is a disease that affects the somatosensory system or pain that results in a lesion. It has been reported that neuropathic pain is more frequently seen in patients with high body mass index.

The hyperreactivity of the central nervous system (CNS) plays an important role in the chronic pain of OA patients. It has been shown that CNS becomes hypersensitive in people with chronic OA pain and central sensitization phenomenon plays an important role in pain complaints reported by these patients.

The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients decided to undergo bariatric surgery
  • Patients with knee pain more than 3 months.

排除标准

  • Patients with mental impairment,
  • Patients with inflammatory rheumatic disease,
  • Patients who had previously undergone knee surgery

结局指标

主要结局

numeric rating scale (NRS)

时间窗: 6 months

It is commonly used to measure the severity of the patients' pain. It consists of a line 10 cm. long and marked with numbers from 0 to 10. The patient is asked to mark the point corresponding to the severity of the pain on this line in the range from 0 (no pain) to 10 (most severe pain).

Nottingham Health Profile

时间窗: 6 months

for quality of life

Central Sensitization Inventory (CSI)

时间窗: 6 months

for central sensitization

Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

时间窗: 6 months

for function

次要结局

未报告次要终点

研究者

发起方
Bursa Yüksek İhtisas Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Burcu Metin Ökmen

Principal Investigator

Bursa Yüksek İhtisas Education and Research Hospital

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