NCT06227806招募中不适用
Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome: a Randomised Controlled Trial
Canisius-Wilhelmina Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Visual analogue pain score (VAS)
研究概览
简要总结
The goal of this randomised controlled trial is to compare a tuberositas transposition (TTT) surgery with a home exercise program (HEP) in patients with patellofemoral pain syndrome (PFPS). The study aims to evaluate the efficiency of TTT in conjunction with a HEP compared to a HEP alone in patients with chronic PFPS.
Participants will randomly be allocated to the surgery or HEP group. Researchers will compare the surgery and HEP groups to see if activity-related pain and patient reported outcome measures (PROMs) are different.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Characteristic history of PFPS (patellofemoral pain during knee loading physical activity, such as jumping, running, squatting);
- •Symptoms lasting at least 12 months;
- •Tibial tubercle trochlear groove (TT-TG) distance of 15mm or more on CT or MRI;
- •Patellofemoral pain during daily life activities, such as: standing for an extended period, walking, or walking upstairs or downstairs
排除标准
- •Previous knee surgery;
- •Reported knee ligamentous or meniscal injuries;
- •Disabling general illness;
- •A history of patellar dislocation; however, subjects with patellar subluxation are included in the study;
- •Other knee problems than PFPS diagnosed clinically (such as jumper's knee);
- •Other knee problems than PFPS diagnosed radiographically (such as osteochondritis - dissecans);
- •Patients who cannot undergo surgery;
- •Pregnancy;
- •Patients with inability to complete follow-up or with limited understanding of the Dutch language
结局指标
主要结局
Visual analogue pain score (VAS)
时间窗: baseline and 12 weeks after HEP or 18 weeks after TTT surgery
10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain.
次要结局
- International Knee Documentation Committee Subjective Knee Form (IKDC)(baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year)
- EuroQol health-related quality of life (EQ-5D-5L) questionnaire(baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year)
- Knee functionality using Decline step down test (DSDT)(baseline and after 26 weeks)
- Kujala pain score(baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year)
- Visual analogue pain score (VAS)(after 6 weeks, 26 weeks, and 1 year)
- Tegner Activity Score(baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Cervical Radiculopathy TrialCervical RadiculopathyNCT03674619Oslo University Hospital180
招募中
不适用
Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive CardiomyopathyHypertrophic CardiomyopathyNCT04684290St. Antonius Hospital100
招募中
不适用
Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus DeformityHallux Valgus DeformityNCT06114043Ostfold Hospital Trust120
已完成
2 期
Comparison of Surgical Procedures to Reduce Urinary Stress IncontinenceUrinary IncontinenceNCT00064662Carelon Research655
招募中
不适用
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 YearsProximal Humeral FractureShoulder FracturesNCT06416618Zealand University Hospital60