Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Peak Spatial Frequency Radius at the Site of Pathology
研究概览
简要总结
This work is designed as a prospective cohort study, in which the effects of low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Patellar tendinopathy (PT) will be monitored on its micromorphology. It is estimated that at least 21 patients will participate. In addition, there will be a small control group of healthy tendons which will be monitored to observe magnitude of natural changes.
详细描述
This work is designed as a prospective cohort study, in which the effects of low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Patellar tendinopathy (PT) will be monitored on its micromorphology. It is estimated that at least 21 patients will participate. In addition, there will be a small control group of healthy tendons which will be monitored to observe magnitude of natural changes.
The research within one patient will last a total of 16 weeks from the initial to the final examination. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a recreational athlete performing intensive sport activity loading patellar tendon (running, jumping, strength training etc.) at least 3 days in a week for minimum of 1 hour per session,
- •is in age between 18-40 years,
- •has a patellar tendon pain, which limits (at least in part) the quality of normal daily or sports activities,
- •has clinical manifestation of patellar tendinopathy (pain and impaired function) confirmed by clinician,
- •has symptoms only in one leg, the other one is asymptomatic.
排除标准
- •Any contraindication for ESWT is present (according to International Society for Medical Shockwave Treatment (ISMST) consensus at https://shockwavetherapy.org),
- •Patient is aware of any symptomatic mechanical tendon damage in the past (e.g., partial or complete rupture in relation to the injury),
- •neurological, oncological, or systemic disease (e.g., neuropathy, lupus or rheumatic arthritis) coexists,
- •is/was already treated for PT elsewhere (e.g., platelet-rich plasma therapy, physiotherapy)
- •is using blood thinning medications or statins.
结局指标
主要结局
Change in Peak Spatial Frequency Radius at the Site of Pathology
时间窗: Change of initial values at 16 weeks follow up after beginning of the therapy.
Measured by spatial frequency analysis software from ultrasound picture in mm. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.
Change in VISA-P Questionnaire Score
时间窗: Change of initial values at 16 weeks follow up after beginning of the therapy.
The VISA-P questionnaire is standardized questionnaire for patients with Patellar tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition.
Change in P6 Parameter at the Site of Pathology
时间窗: Change of initial values at 16 weeks follow up after beginning of the therapy.
Measured by spatial frequency analysis software from ultrasound picture in mm. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the P6 parameter.
次要结局
- Change in Tendon Diameter at the Place of Maximum Tendon Width(Change of initial values at 16 weeks follow up after beginning of the therapy.)
研究者
Stanislav Machač, Ph.D
Principal investigator
University Hospital, Motol