跳至主要内容
临床试验/NCT02576028
NCT02576028已完成不适用

Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty: a Randomized Controlled Trial.

Azienda Ospedaliera Bolognini di Seriate Bergamo0 个研究点目标入组 51 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
主要终点
change of pain during movement

研究概览

简要总结

Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care.

详细描述

Background. Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care.

Methods. Fifty-one subjects operated with THA were randomized into two groups, both followed a standard protocol of care where two sessions were replaced with Fascial Manipulation in the study group. Functional outcomes measures collected before and after treatment and at the end of the rehabilitation program included Harris Hip Score, Time Up and Go test, articular range of motion and verbal numerical scale.

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
Single (Investigator)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •first THA surgery,
  • •posterior-lateral access,
  • •onset of pain of maximum 2 years

排除标准

  • •patients with previous hip or knee prosthesis,
  • •congenital hip dysplasia,
  • •revision THA,
  • •elective THA secondary to trauma,
  • •real leg-length discrepancy (≥1.5cm),
  • •cognitive impairment,
  • •concomitant rheumatic pathology in acute phase,
  • •serious comorbidities including cardiac,
  • •respiratory and/or neuromuscular pathologies.

研究组 & 干预措施

standard treathment

Other

two sessions of 45 minutes of active exercises for 10 days

干预措施: standard active exercises (Other)

FM associated to standard treathment

Experimental

the same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment.

干预措施: Fascial Manipulation® (FM) (Other)

FM associated to standard treathment

Experimental

the same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment.

干预措施: standard active exercises (Other)

结局指标

主要结局

change of pain during movement

时间窗: change from before and after the 2nd day treatment, change from before and after the 7nd day treatment, change from 2nd and 10th day (end of study)

value of pain during a specific movement , measured with Visual Numeric Scale (VNS) scale

次要结局

  • Range of motion (ROM)(before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study))
  • Harris Hip Score(before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study))
  • Timed up and Go test (TuG)(before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study))

研究者

发起方
Azienda Ospedaliera Bolognini di Seriate Bergamo
申办方类型
Other
责任方
Sponsor

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