NCT02706756撤回不适用
Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Did subject elect to undergo surgery?
研究概览
简要总结
- Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups.
- Interventions will be provided based on randomized assignment. Group 1 will receive treatment based on identified impairments and treated twice weekly to address said impairments with hip manual therapy and exercise, as well as a prescriptive exercise for strengthening and mobility of the hip. Group 2 will receive only the prescriptive exercise program. Group 3 will be a control group (supervised neglect)
- Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for assessment of the primary outcome measure of the HAGOS. Secondary analyses will include chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and expectations measures), or other appropriate comparative measures. None of the proposed treatment is considered outside of 'standard of practice'.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals age 18 to 60 years,
- •diagnosed with FAI by an orthopedic surgeon and exhibiting
- •hip/groin symptoms for at least 3 months (symptomatic); and
- •signs, symptoms and imaging findings conducive to FAI will be recruited from a surgical practice of an orthopedic surgeon in Durham, North Carolina.
排除标准
- •subjects that have radiographic evidence of hip osteoarthritis that is more than mild in severity defined as Tonnis >grade 1 or Kellgren-Lawrence >2;
- •have other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures;
- •exhibit hip dysplasia (center edge angle <20 degrees on AP radiograph
- •are unable to attend a study physiotherapist or participate in the rehabilitation program if randomized to the PT group;
- •are unable to understand English.
结局指标
主要结局
Did subject elect to undergo surgery?
时间窗: up to 6 months after intervention
Determination of whether the subject had surgery for femoroacetabular impingement or not
次要结局
- Change in Stanford Expectations of Treatment Scale (SETS)(initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit)
- Change in numeric pain rating scale(initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit)
- Change in Standing Hip Internal Rotation Range-of-Motion(initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit)
- Change in Complications/Adverse Events of assigned treatment(initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit)
- Change in Patient Acceptable Symptom State (PASS)(initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit)
- Change in Hip and Groin Outcome Score(initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit)
- Change in Lower Quarter Y Balance Test (YBT-LQ)(initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit)
- Change in Single leg stance (SLS)(initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit)
- Change in Single Leg Anteroposterior Hop(initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit)
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