Effect of Pulsed Signal Therapy in Patella Chondromalacia. Randomized Prospective Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Clinical improvement - Kujala score
研究概览
简要总结
PST (pulsed signal therapy) is a unique form of pulsed electromagnetic field therapy (PEMF) for stimulating healing of damaged structures such as cartilage, bones and soft tissues. The physical effect of the pulsed electromagnetic field (PEMF) has been focus of research in various studies, with cartilage being the most studied, and which has demonstrated an increase in the synthesis of proteoglican and collagen in vitro. This is an randomized, controlled and double blind clinical trial. The main objective is to evaluate clinical improvement regarding anterior knee pain after PST intervention in patients with patellar condropathy.
详细描述
The study was approved by the Research Ethics Committee of the Clinical Hospital (Hospital das Clinicas), University of São Paulo (Universidade de São Paulo - USP) under number 0253/11.
This patient population is estimated to a total of 40 knees, with the patients meeting the following inclusion criteria:
- aged between 20 and 50 years;
- male or female;
- patellofemoral pain syndrome without tibiofemoral and trochlear chondral degeneration according to magnetic resonance imaging (MRI);
- presence of patellar chondropathy confirmed by MRI;
- not having started using direct action drugs on the cartilage in the last 6 months;
- absence of prior surgery on the studied knee;
- absence of invasive procedures, such as knee infiltration, in the previous 12 months;
- absence of disease in the contralateral limb that would cause an excessive burden on the studied limb; and
- absence of contraindications to performing PST, including a pacemaker, cancer, infectious disease activity, severe heart failure, arrhythmias, angina, epilepsy and pregnancy.
The presence of patellofemoral pain is identified by anamnesis and physical examination performed by knee surgeons with more than 10 years' experience. The presence of all of the following criteria is required for diagnosis: typical complaint of anterior knee pain with a duration longer than 3 months (when going up or down stairs, squatting, remaining for long periods with bent knees), pain on palpation of the patellar articular surface and pain on patellar compression (reproducing the patient's complaint).
After inclusion in the study, all of the patients will be instructed (for the duration of the study) not to use drugs with a direct action on the cartilage (e.g., chondroprotectors, such as glucosamine and chondroitin) to avoid confounding biases regarding the effects of the treatments. No patients will be included who had started using these drugs in the previous 6 months to avoid the initial effect of this treatment being a confounder in terms of clinical improvement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patellofemoral pain syndrome without tibiofemoral and trochlear chondral degeneration according to magnetic resonance imaging (MRI);
- •presence of patellar chondropathy confirmed by MRI;
- •not having started using direct action drugs on the cartilage in the last 6 months;
- •absence of prior surgery on the studied knee;
- •absence of invasive procedures, such as knee infiltration, in the previous 12 months;
- •absence of disease in the contralateral limb that would cause an excessive burden on the studied limb; and
- •absence of contraindications to performing PST, including a pacemaker, cancer, infectious disease activity, severe heart failure, arrhythmias, angina, epilepsy and pregnancy.
排除标准
- 未提供
结局指标
主要结局
Clinical improvement - Kujala score
时间窗: 12 months
A functional score (Kujala) will be performed before, at 3 months, at 6 months and at one year after PST intervention and placebo.
次要结局
未报告次要终点
研究者
Marco Kawamura Demange
Assistant Professor
University of Sao Paulo General Hospital