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临床试验/NCT01899482
NCT01899482已完成不适用

Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial

Technical University of Lisbon2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2013年7月1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
41
试验地点
2
主要终点
Quality of Life

研究概览

简要总结

The purpose of this study is to compare functional status and quality of life of a group of patients with chronic venous insufficiency treated with manual lymphatic drainage with a group not treated with manual lymphatic drainage.

Investigators hypothesized that manual lymphatic drainage can improve:

  • quality of life,
  • functional status,
  • calf muscle strength,
  • ankle range of motion,
  • edema,
  • severity of disease,
  • and symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnose of chronic venous insufficiency class C3-5 for Clinical-Etiological-Anatomical-Pathological classification (CEAP).

排除标准

  • Severe cardiac insufficiency,
  • Acute venous or arterial obstruction,
  • Arterial insufficiency, renal insufficiency,
  • Uncompensated thyroid dysfunction,
  • Pregnancy, neoplastic pathology,
  • Systemic or limb infection,
  • Recent musculoskeletal injury in the lower limb,
  • Peripheral neuropathy in the lower limb.

结局指标

主要结局

Quality of Life

时间窗: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days)

Evaluated by portuguese version of Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-2).

次要结局

  • Hemodynamic evidence of severity of chronic venous disease(Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).)
  • Sel-reported functional status(Assessed at aseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days))
  • Lower extremity symptoms(Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).)
  • Leg edema(Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).)
  • Clinical severity of chronic venous insufficiency(Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).)
  • Calf muscle strength and ankle range of motion(Assessed at aseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days))

研究者

发起方
Technical University of Lisbon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rute Sofia dos Santos Crisóstomo

PhD student

Technical University of Lisbon

研究点 (2)

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