Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy Using Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 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 randomized clinical trial, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon and low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 40 patients will participate, randomly divided into two groups. Group A will be instructed to perform a training protocol in combination with ESWT according to selected parameters. Group B only completes the same training protocol.
详细描述
This work is designed as a randomized clinical trial, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon and low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 40 patients will participate, randomly divided into two groups. Group A will be instructed to perform a training protocol in combination with ESWT according to selected parameters. Group B only completes the same training protocol.
The research within one patient will last a total of 39 weeks from the initial to the final examination and will include several control measurements: at 6, 12, 26 and 39 weeks from the beginning of therapy. 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. At the end of the initial examination, the participant will be randomly assigned to group A or B. The study program for a specific participant will depend on the assigned group.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in the area of Achilles tendon), which at least partially limit his quality of life during normal or sporting activities,
- •the patient is in the age group of 18-60 years,
- •the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference,
- •the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury),
- •the patient has not undergone any treatment aimed at AS in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US examination of AS shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.).
排除标准
- •patient has been diagnosed with a rheumatic disease or a disease of the central nervous system
- •patient has any condition which is contraindication for ESWT application
- •patient is aware of mechanical damage to the Achilles tendon as a result of an injury in the past.
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 39 weeks follow up after beginning of the therapy.
Measured by spatial frequency analysis software from ultrasound picture in mm-1. 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-A Questionnaire Score
时间窗: Change of initial values at 39 weeks follow up after beginning of the therapy.
The VISA-A questionnaire is standardized questionnaire for patients with Achilles tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition.
Peak Spatial Frequency Radius at the Site of Pathology
时间窗: Values at baseline and week 26.
Peak Spatial Frequency Radius (PSFR) was assessed using spatial frequency analysis (SFA) software applied to standardized B-mode ultrasound images of the Achilles tendon. Ultrasound images were acquired in a long-axis using predefined machine settings. The image was saved and exported for subsequent analysis. In the SFA software, the region corresponding to the site of maximal tendon pathology was selected, and PSFR values (mm-¹) were calculated. PSFR values were recorded at baseline and at the 26-week follow-up.
VISA-A Questionnaire Score
时间窗: Values at baseline and week 26.
The VISA-A questionnaire is a validated, disease-specific patient-reported outcome measure for Achilles tendinopathy. Scores range from 0 to 100 (score on scale), with higher scores indicating better function and fewer symptoms. Scores were recorded at baseline and at the 26-week follow-up.
次要结局
- Change in Tendon Diameter at the Place of Maximum Tendon Width(Change of initial values at 39 weeks follow up after beginning of the therapy.)
- Change in Maximum Pain in the Achilles Tendon Area(Change of initial values at 39 weeks follow up after beginning of the therapy.)
- Tendon Diameter at the Place of Maximum Tendon Width(Values at baseline and week 26.)
- Pain Intensity Measured by Numeric Rating Scale (NRS)(Values at baseline and week 26)
研究者
Stanislav Machač, Ph.D
Academic worker
Charles University, Czech Republic