跳至主要内容
临床试验/NCT03949127
NCT03949127进行中(未招募)不适用

Efficacy of a Non-surgical Treatment Protocol for Patients With Symptomatic Femoro-acetabular Impingement: a Randomized Controlled Trial

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2019年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
95
试验地点
2
主要终点
iHOT-33

研究概览

简要总结

The purpose of this study is to examine whether using an exercise regime on people with femoroacetabular impingement (FAI) can help reduce pain and improve function. Also, it examines whether the exercise regime will help prevent the worsening of hip cartilage deterioration.

详细描述

A significant proportion of adults from ages 18 to 50 have a deformity in the neck of their femur. This can be painful and is called a femoroacetabular impingement (FAI), and could lead to ones cartilage being destroyed and possibly lead to osteoarthritis of the hip. People with this deformity in their femur have been found to move their hips differently when doing tasks such as walking, squatting or climbing stairs compared to those without this problem. The investigators are testing whether exercise that targets this difference in movement can help reduce pain, improve function and prevent cartilage damage. There will recruit 84 patients with divided into 2 groups. 42 patients will do a 8 week exercise program on strengthening muscles responsible for extending the hip and stretching muscles that are associated with flexing the hip. The intensity of the program will change with visits to the physiotherapist through the course of their exercise program. This research hopes to develop an innovative, non-surgical, low-cost, highly feasible and accessible intervention for patients with FAI.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosed with symptomatic FAI
  • at least 3 months of groin pain
  • increased pain with hip rotation
  • an alpha angle greater than 60 degrees on multiplane imaging
  • labral tear on MRI
  • Tonnis grade of 0 or 1

排除标准

  • diagnosed health problems other than FAI interfering with capacity to accomplish the exercise program
  • previous hip surgery on the affected side
  • surgery will happen within 6 months

结局指标

主要结局

iHOT-33

时间窗: Change in Baseline before exercise program and 6 months

International Hip Outcome Tool-33, disease-specific function. Each answer will be measured on a scale of 100mm and the mean of the 33 questions will be taken as a final score. A higher score indicates a better quality of life.

次要结局

  • Patient-reported hip pain(Change in Baseline before exercise program and 6 months)
  • EQ-5D-5L(Change in Baseline before exercise program and 6 months afterward)
  • Number of participants that receive hip surgery(Change in Baseline before exercise program and 1 year afterwards)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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