Optimization of the Diagnostic Process and Physiotherapist-led Treatment of Patients With Femoroacetabular Impingement Syndrome: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in HAGOS Sport subscale
研究概览
简要总结
This prospective study with a two-group comparison design investigates the effectiveness of 12-weeks of semi-structured and supervised physiotherapist-led treatment on self-reported hip and groin function in patients with femoroacetabular impingement syndrome with and without intra-articular hip pain. Determination of intra-articular hip pain is based on pain relief following an ultrasound-guided intra-articular anesthetic hip injection performed prior to commencing treatment.
详细描述
The treatment of femoroacetabular impingement syndrome (FAIS) consists of wait-and-see, physiotherapist-led treatment, and/or hip surgery. The primary indication for hip surgery is based on imaging findings, however, limited correlation has been observed between such findings and hip symptoms. As patients with FAIS often show physical impariments, such as impaired hip muscle function, physiotherapist-led treatment aiming to address such factors may be effective in improving hip function and pain in some patients. However, several factors may confound the effect of physiotherapist-led treatement of FAIS, such as whether the patient presents with intra-articular hip joint pain or not.
Thus, the purpose of this prospective study with a two-group comparison design is to investigate the effect of 12-weeks of physiotherapist-led treatment on self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS), in subjects diagnosed with FAIS, but with and without intra-articular hip pain. Determination of intra-articular hip pain is based on the response to an ultrasound-guided intra-articular anesthetic hip injection performed prior to commencing treatment.
Subjects diagnosed with FAIS based on symptoms, clinical signs and imaging findings will be prospectively recruited from a specialized outpatient hip and groin clinic at Hvidovre Hospital. Following inclusion subjects undergo 12-weeks of semi-structured and supervised physiotherapist-led treatment. The primary outcome measure is the between-group (intra-articular pain vs. no intra-articular pain) difference in mean change of the HAGOS sport subscale from baseline (week 0) to follow-up (week 12).
The primary outcome measure will be publised in the primary paper, which will also include information on between-group difference in change in hip muscle strength and single-leg hop performance as secondary outcome measures.
Secondary papers will be reported with a clear reference to the primary paper.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Participants will be blinded to the potential value of the diagnostic findings, such as response to intra-articular hip injection.
Outcome assessor will be blinded to diagnostic findings, such as response to intra-articular hip injection.
Care Provider (Physiotherapist supervising the intervention) will be blinded to diagnostic findings, such as response to intra-articular hip injection.
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
- •Activity-related longstanding hip and/or groin pain for >3 months
- •Known anterior and/or medial groin pain during the FADIR test with a pain severity of ≥2/10 on NRS.
- •Radiological findings on plain radiographs of cam morphology defined as alpha angle >55° on a lateral view.
排除标准
- •Inguinal-related groin pain diagnosed according to Doha Agreement.
- •Pubic-related groin pain diagnosed according to Doha Agreement.
- •Evidence of pre-existing hip osteoarthritis, defined as a joint space width <3 mm at the lateral sourcil on anterior-posterior pelvic radiograph.
- •Previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia defined as a Lateral Center Edge Angle <25°, or avascular necrosis.
- •Other causes of hip and groin pain identified by the orthopedic surgeon during the clinical examination, such as stress fracture of the femoral neck, referred pain from the facet joint, referred pain from the sacroiliac joint, or other competing diagnosis (rheumatoid arthritis, cancer etc.)
- •Previous hip injury such as acetabular fracture, hip dislocation, or femoral neck fracture.
- •Previous intra- or extra-articular hip surgery.
- •Pregnant.
- •Intra-articular steroid hip injection during the preceding 3 months.
结局指标
主要结局
Change in HAGOS Sport subscale
时间窗: 12 weeks
The primary outcome measure is the between-group (intra-articular pain vs. no intra-articular pain) difference in change in self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) Sport subscale from baseline to follow-up in subjects diagnosed with FAIS. The HAGOS Sport subcale is scored on a scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems).
次要结局
- Return to sport(12 weeks)
- Treatment expectations and fulfilment of expectations(12 weeks)
- Change in hip peak torque(12 weeks)
- Patient acceptable symptom state(12 weeks)
- Change in single leg hop performance(12 weeks)
- Change in HAGOS subscales(12 weeks)
- Change in hip rate of torque development(12 weeks)
- Change in isometric adduction squeeze torque(12 weeks)
研究者
Lasse Ishøi
Principal Investigator
Hvidovre University Hospital