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临床试验/NCT04580069
NCT04580069已完成不适用

Effectiveness of Two Rehabilitative Treatments in the Modulation of Inflammation During the Acute Phase in Patients With Knee Prosthesis and Assessment of the Role of the Diet in Determining Post-surgical Inflammation.

Presidio Ospedaliero di Asiago4 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
4
主要终点
ESR variation

研究概览

简要总结

The investigators studied the influence of two aproved rehabilitative treatments, connective tissue techniques and lymphatic drainage, on acute inflammation markers. Furthermore, the role of mediterranean diet on the same values was investigated in the first postoperative period

详细描述

The main objective of this study is to demonstrate the effectiveness of lymphatic drainage and connective tissue techniques in modulating systemic inflammation. Another objective is to evaluate the existence, at baseline, of a correlation between the inflammation indices and the level of adherence to the Mediterranean diet.

Methods. 34 patients were recruited, and divided into three groups. The control group followed the normal rehabilitation protocol. The other two groups were subjected, in addition to the standard treatment, to manual lymphatic drainage treatment or connective tissue techniques. The outcomes (PCR, ESR, Oedema) were recorded in three stages: upon entering the hospital, 1 week after entry and at follow-up 21 days after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50<age<80 years
  • Bicompartmental knee arthroplasty
  • Weight bearing 7 days after surgery
  • Transfusions according to hospital protocol
  • Alteration of the indices at T0
  • Standard analgesic therapy

排除标准

  • Joint replacements from other Units
  • Inflammatory arthropathies
  • Autoimmune / rheumatic diseases
  • Diabetes mellitus
  • Infections

结局指标

主要结局

ESR variation

时间窗: 21 days

blood test

CRP variation

时间窗: 21 days

blood test

lower limb oedema

时间窗: 21 days

leg circumference

次要结局

未报告次要终点

研究者

发起方
Presidio Ospedaliero di Asiago
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergio Rigoni

Sergio Rigoni

Presidio Ospedaliero di Asiago

研究点 (4)

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