MovetheHip-trial: The Effectiveness of Exercise and Patient Education Compared With Usual Care on Self-reported Pain in Patients With Hip Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)
研究概览
简要总结
This effectiveness trial will investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.
Participating patients will be allocated to either exercise and patient education or usual care. Alongside this, a health-economic study and a process-evaluation study will be conducted.
详细描述
This study is a parallel-group superiority randomised controlled trial. Alongside this, a health-economic study and a process-evaluation study will be conducted. Participating patients will be allocated to either exercise and patient education or usual care at a 1:1 ratio. The primary outcome is change in self-reported pain measured with Copenhagen Hip and Groin Outcome Score (HAGOS) from baseline to 6-month follow-up.
The effectiveness of exercise and patient education compared with usual care will be reported in the primary trial paper, including the primary outcome and the following secondary outcomes: HAGOS symptoms, HAGOS function in daily living (ADL), HAGOS function in sport and recreation (sport/recreation), HAGOS participation in physical activity (participation), HAGOS quality of life (QOL), the impact of hip disease with the Short Version of the International Hip Outcome Tool (iHOT-12), lower limb reach length (anterior, posteromedial, posterolateral), single-leg hip for distance (SLHD) test and hip muscle strength (flexion, extension and abduction).
The primary aim of this effectiveness trial is to investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.
The primary hypothesis: Patients randomised to exercise and patient education will have a between-group mean change score on the HAGOS pain that is at least 10 points higher than those randomised to usual care over a 6-month follow-up period.
The secondary aims are to compare mean changes between the two groups on the other HAGOS subscales over a 6-month follow-up period. Similar comparisons will be made on self-reported mean changes in the Short Version of the International Hip Outcome Tool (iHOT-12) and mean changes in performance, balance and hip muscle strength.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographically verified hip dysplasia by a Wiberg's centre edge (CE) angle of 10-25 degrees and an acetabular Index (AI) angle >10 degrees
- •Hip and/or groin pain as primary pain for at least three months
- •Candidate for periacetabular osteotomy (PAO) but unwilling to undergo PAO, or on a waiting list for surgery (PAO) for 12 months or longer
- •Not candidate for PAO (negative impingement test, BMI >25, hip osteoarthritis, age >45 years or reduced hip range of motion)
排除标准
- •Self-reported pain score >80 points measured with Copenhagen Hip and Groin outcome score
- •Any major planned surgery (i.e. arthroplastic surgery or discectomy surgery)
- •Acetabular retroversion defined by crossover sign and posterior wall sign
- •Calvé Legg Perthes or epiphysiolysis
- •Previous pelvic/hip surgery in index limb
- •Previous pelvic/hip surgery within the last 2 years in contralateral limb
- •Previous surgery due to herniated disc or spondylodesis
- •Previous arthroplastic surgery in the hip, knee or ankle
- •Physical (pregnancy/trauma), neurological, medical or rheumatic conditions severely affecting the hip function
- •Inadequacy in written and spoken Danish, mental illness or other conditions affecting the ability to follow mandatory procedures for participation
研究组 & 干预措施
Usual Care
6-months
干预措施: Usual Care (Other)
Exercise and patient education
6-months
干预措施: Exercise and patient education (Other)
结局指标
主要结局
Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)
时间窗: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
HAGOS pain sub-item measures degree of hip and/or groin pain through ten individual questions on a score from 0 to 100, higher score indicates lower pain.
次要结局
- Change in isometric hip flexion strength using a dynamometer with external belt-fixation (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up)
- Change in self-reported physical function, daily living (ADL) measured with HAGOS (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time))
- Change in self-reported physical function in sports and recreational activities (sport/recreation) measured with HAGOS (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time))
- Change in self-reported quality of life (QOL) measured with HAGOS (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time))
- Change in impact of hip disease using the Short Version of the International Hip Outcome Tool (iHOT- 12) (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up. In addition at 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time))
- Change in anterior lower limb reach distance measured with the Y-balance test (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up)
- Change in posteromedial lower limb reach distance measured with the Y-balance test (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up)
- Change in single-leg jump distance measured with single-leg hop for distance test (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up)
- Change in isometric hip extension strength using a dynamometer with external belt-fixation (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up)
- Change in posterolateral lower limb reach distance measured with the Y-balance test (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up)
- Change in self-reported symptoms measured with HAGOS (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time))
- Change in self-reported participation in physical activities (participation) measured with HAGOS (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time))
- Change in isometric hip abduction strength using a dynamometer with external belt-fixation (continuous data)(From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up)