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.
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
- 否
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
Sergio Rigoni
Sergio Rigoni
Presidio Ospedaliero di Asiago
