Influence of Placebo on Intratissue Percutaneous Electrolysis (IPE) Treatment in Patients With Patellar Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Physical performance of the knee
研究概览
简要总结
The main aim of this study is to verify the influence of placebo on the effectiveness of Intratissue Percutaneous Electrolysis (IPE) in patients suffering from with chronic patellar tendinopathy (PT).
The secondary aim is to investigate the possible influence of the IPE on pain perception and conditioned pain modulation (CPM) in patients with chronic PT.
详细描述
The aim of this study is to investigate the influence of placebo on the effectiveness of Intratissue Percutaneous Electrolysis (IPE) in patients with chronic PT. For this purpose a randomized clinical trial will be carried out, with a sample of patients diagnosed of chronic PT based on signs, symptoms and clinical examination. Subjects will be randomly allocated to four different groups: group E1, IPE will be applied, participants will believe they are receiving IPE; group E2, IPE will be applied, participants will believe they are receiving placebo; group P1, IPE will not be applied, participants will believe they are receiving IPE; and group P2, IPE will not be applied, participants will believe they are receiving placebo.
IPE treatment will consist of a total of 3 sessions, with a time interval of one week between the 1st and 2nd sessions and 2 weeks between the 2nd and 3rd sessions.
To evaluate the effect of intervention, the subjects will be assessed at baseline (V0), one week after the end of the intervention (V1) and 3 weeks after the intervention (V2).
In V0, sociodemographic (sex, age, profession, height, body mass index (BMI), sport activity, hours of sport per week) and clinical data (associated pathologies, affected lower limb, dominant lower limb, duration of symptoms) will be registered. In each assessment time information regarding BMI, sports activity, hours of sport per week and location of pain will be obtained. Moreover, in all assessments participants were evaluated for four physical performance tests, pain and functional scales, ultrasound examination, pressure pain thresholds, conditioned pain modulation, and expectations questionnaires.
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 (Participant, Outcomes Assessor)
盲法说明
Participants don't know to which intervention group they belong to. The outcomes assessor doesn't know to which intervention group the patient belongs to.
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
- •18 years old or older
- •presenting the following signs and symptoms of patellar tendinopathy: pain when jumping, landing, running o changing direction, pain at the inferior pole of the patella, Victorian Institute of Sport Assessment-Patella (VISA-P) score <80, symptoms duration of at least 3 months.
排除标准
- •prior knee surgery
- •patients having received local corticosteroids injection in the tendon within the preceding 6 months
- •patients presenting any inflammatory disease, metabolic bone disease, type II diabetes, fibromyalgia, hypercholesterolemia, pregnancy or chemotherapy within the 3 months prior to the study.
结局指标
主要结局
Physical performance of the knee
时间窗: Three weeks post-intervention
Physical performance of the knee will be assessed by the Single Leg Decline squat (SLDS), which consists of performing a squat with one leg on a decline board with an angle of 25º.
Cross-sectional area (CSA) of the patellar tendon
时间窗: Three weeks post-intervention
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Pain intensity
时间窗: Three weeks post-intervention
Knee pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
Patellar tendon function
时间窗: Three weeks post-intervention
Victorian Institute of Sport Assessment-Patellar Tendon (VISA-P, 0-100, 0=minimum score, 100=maximum score) will aso be used to evaluate function of the patellar tendon. A score between 80-100 points is considered as the optimal outcome.
Amount of neovascularity of the patellar tendon
时间窗: Three weeks post-intervention
The amount (0=no vascularity, 1=low fow, 2=mild flow, 3=high flow) of neovascularity of the patellar tendon will be measured by ultrasonography.
Presence of neovascularity of the patellar tendon
时间窗: Three weeks post-intervention
The presence (yes/no) and amount (0=no vascularity, 1=low fow, 2=mild flow, 3=high flow) of neovascularity of the patellar tendon will be measured by ultrasonography.
次要结局
- Self-perceived change with the treatment(Three weeks post-intervention)
- Pressure Pain Thresholds (PPT)(Three weeks post-intervention)
- Self-perceived pain after treatment(Three weeks post-intervention)
- Conditioned pain modulation (CPM)(Three weeks post-intervention)
- Patients' expectations(Baseline)
研究者
Mercè Balasch i Bernat
Principal investigator
University of Valencia