Comparative Effectiveness of Therapeutic Hip and Knee Exercise for Atellofemoral Pain: A Pragmatic Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change from baseline in the KUJALA scoring questionnaire
研究概览
简要总结
Patellofemoral Pain (PFP) is a common knee problem, primarily affecting adolescents and young adults. PFP is characterised by significant retropatellar and/or peripatellar pain and impairment of function and quality of daily life. Exercise therapy is unequivocally recommended as a core component of the management of PFP. Different exercise types (e.g. quadriceps strengthening, hip strengthening and functional/neuromuscular exercises) have been investigated, with knee and hip strengthening exercises as the most common and recommended types. These exercises approaches produce similar small to moderate effects on pain and physical function. However, the PFP population is very heterogeneous and "one-size-fits-all"-approaches presumably are sub-optimal because the heterogeneity is ignored. The heterogeneity probably explains the overall limited beneficial effects of exercise, and the lack of differences in direct comparisons of different exercise types. In that sense, it is not unlikely that certain patient characteristics may predict outcome success of either a hip training program or a training program that focus on the quadriceps but this remains to be shown.
This study has two aims:
- To assess the comparative effectiveness of two different exercise programs (Quadricep Exercise [QE] vs. Hip Exercise [HE]) on self-reported pain and function in individuals with PFP.
- To explore candidate patient characteristics that predict differential responses to the two exercise programs (QE vs HE) on self-reported pain and physical function in individuals with PFP.
According to the study aims we pursue the following hypothesis:
- QE and HE have equivalent efficacy on self-reported pain after 12 weeks of treatment in patients with PFP.
The second study aim is to explore possible candidate patient characteristics that may associate with differential outcomes. As this is exploratory, the pursuit of this aim is hypothesis-free.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators, study coordinators, outcome assessors, clinical staff, study staff, and other personnel directly involved in the clinical activities of the study, will be blinded to the group allocation.
Participants and providers of the exercise delivery are not blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of PFP in at least one knee
- •Visual analogue score rating of pain during activities of daily living during the previous week at a minimum of 3 on a 10 cm scale.
- •Insidious onset of symptoms unrelated to trauma and persistent for at least 4 weeks.
- •Pain in the anterior knee associated with at least 3 of the following:
- •During or after activity
- •Prolonged sitting
- •Stair ascent or descent
- •Squatting
排除标准
- •Meniscal or other intra-articular injury
- •Cruciate or collateral ligament laxity or tenderness
- •Patellar tendon, iliotibial band, or pes anserine tenderness
- •Osgood-Schlatter or Sinding-Larsen-Johansson syndrome
- •History of recurrent patellar subluxation or dislocation
- •History of surgery to the knee joint
- •History of head injury or vestibular disorder within the last 6 months
结局指标
主要结局
Change from baseline in the KUJALA scoring questionnaire
时间窗: week 12 and 26
The Kujala Patellofemoral Scale - sometimes called the anterior knee pain scale - is disease specific validated disability scale ranging from 0 (complete disability) to 100 (fully functional). It is a 13-item self-report questionnaire that documents response to 6 activities (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear, swelling, abnormal patellar movement, muscle atrophy, and limitations in knee flexion.
次要结局
- Change fom baseline in the Pain Self-Efficacy Questionnaire(Week 12 and 26)
- Change fom baseline in isometric muscle strength of hip abductors, hip external rotators, hip extensors, and quadriceps(Week 12)
- Transition Questionnaire of global perceived effect on overall health, pain, and function(Week 12 and 26)
- Change from baseline in the KOOS questionnaire(Week 12 and 26)
- Change fom baseline in the EuroQoL Questionnaire(Week 12 and 26)
- Change fom baseline in the Dynamic Assessment of Pain test(Week 12)
研究者
Marius Henriksen
Professor
Frederiksberg University Hospital