The Effect of Patients' Characteristics on the Responsiveness to Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: a Multi-center, Single-group, Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in hip pain, function and quality of life
研究概览
简要总结
The aim of the clinical trial is to investigate the characteristics of patients, who respond vs. not respond to exercise therapy for the nonsurgical management of femoroacetabular impingement syndrome (FAIS).
详细描述
Patients with a diagnosis of FAIS will be recruited from 2 clinical centers and will receive exercise therapy (study intervention). Exercise therapy is a semi-standardized intervention and will last 12 weeks (3 months). Hip pain, function and quality of life will be assessed using a patient-reported questionnaire at baseline, 3, 6 and 12 months' follow-up. Hip joint contact pressure will be evaluated using motion analysis and modelling at baseline, 3 and 12 months' follow-up. Hip morphology will be evaluated using imaging at baseline and hip surgery rate will be evaluated at 6 and 12 months' follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 50 years;
- •Diagnosis of FAIS;
- •Availability of magnetic resonance arthrography and anteroposterior pelvic radiography of the involved hip;
- •Signed informed consent form.
排除标准
- •Previous hip surgery;
- •Any surgery on the lower extremities in the last 6 months;
- •Hip dysplasia: lateral center edge angle <25°;
- •Hip osteoarthritis: Tönnis grade >1;
- •BMI: >35 kg/m2;
- •Significant cardiopulmonary diseases.
结局指标
主要结局
Change in hip pain, function and quality of life
时间窗: Baseline to 6 months' follow-up
Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
次要结局
- Change in hip pain, function and quality of life(Baseline to 3 months' follow-up)
- Dropout(3 months' follow-up)
- Change in hip joint contact stress(Baseline to 12 months' follow-up)
- Hip surgery rate(12 months' follow-up)
- Hip morphology(Baseline)
- Change in sport activity level(Baseline to 12 months' follow-up)