Characterization of the Effects on Bioimpedance and the Sensorimotor System After the Application of Percutaneous Electrolysis Protocols on the Patellar Tendon.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in pain evoked with Von Frey Filaments.
研究概览
简要总结
Percutaneous electrolysis is a physical therapy technique, whose main objective is the treatment of the signs and symptoms associated with tendinopathies by applying a galvanic current through a blunt dry needle. Despite its clinical use being already stablished, the physiological mechanisms underlying this therapy are still unknown and thus, the optimal parameterization. The present study proposes to perform different stimulation protocols of percutaneous electrolysis on healthy subjects patellar tendon to answer those questions.
详细描述
Intervention will be performed in the middle of the patellar tendon, using ultrasonography to guide the needle insertion, without risk of affecting any adjacent structure. The theoretical basis of the technique is to produce specific controlled changes in the intervened tissue, and the pathological symptoms, through the accumulation of an electric charge. For this reason, the protocols will be the following:
- High-intensity and short-duration: 3 squared pulses of a high intensity galvanic current (3 mA) for 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp. The current will be off during the first 348 seconds of the intervention and the last 18 seconds it will be on. The total intervention time will be 366 seconds.
- Low-intensity and long-duration: 3 squared pulses of a low intensity galvanic current (0.1 mA) during 90 seconds, with 3 seconds rests between pulses and 30 seconds of pulses ramp. The total intervention time will be 366 seconds.
- High-intensity, short-duration and 20 Hertz (Hz): 3 squared pulses of a high intensity compensated biphasic squared current (3 mA), during 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp. The alternative frequency of 20 Hz and the pulse width of 50 ms. The current will be off during the first 348 seconds of the intervention and the last 18 seconds it will be on. The total intervention time will be 366 seconds.
- Sham electrolysis group will got the same intervention, but without applying electrical current.
The study design will be an crossover clinical trial, with randomized order of intervention with repeated measurements. Therefore, each subject will be have the four protocols at randomized order, with a gap of at least one week between them. The study will be full blinded.
The capacity to recruit the inhibitory system will be evaluated by means of conditioned pain modulation. Moreover, somatosensory thresholds will be evaluated in the knee, as well as knee extension strength. In addition, we will undertake continuous measures of the electrical bioimpedance of the patellar tendon, to study the changes produced by the intervention in the different intra and extracellular tissue components.
The conditioned modulation of pain assesment will take place one week before to the intervention, and the remaining measurements will be measured pre-intervention and post-intervention for each protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The order of the interventions will be randomized by a third person not involved in the treatment, assessment or statistical analysis. Once the care provider has inserted the needle in each subject, the investigator that apply the treatment will choose the treatment protocol assigned on the stimulator, previously programmed and codified. Thus, nobody (participant, care provider, investigator and the outcome assessor) will know what intervention is applied.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 45 years old.
排除标准
- •to suffer or to have suffered any pathology on the arm on the last 30 days.
- •to suffer some disease discouraging current application or needling, as coagulation deficit, etc.
- •to suffer some severe disease as diabetes mellitus, cancer, neurology disease, depression, fibromyalgia, etc.
- •to suffer some cognitive disorders.
- •to consume drugs as coagulants, anti-depressant, pregabalin, neuropeptide, opioids, etc during investigation or the first week before investigation.
- •to consume NSAIDS the last 48 hours before investigation or during investigation.
- •belonephobia.
- •To consume caffeine 2 hours prior to the investigation or perform intense exercise on the same day as the measurement.
- •To receive concomitant physical therapy treatments or have previously received percutaneous electrolysis treatment.
- •professional athlete
- •To be pregnant.
结局指标
主要结局
Change in pain evoked with Von Frey Filaments.
时间窗: Pre-intervention and immediately after the intervention
We will use Von Frey Filaments to apply a 300g pressure in the evaluated areas (tibialis anterior muscle, inferior pole of the patella and patellar tendon). The subject will report the pain intensity verbally administered Numeric rate scale (NRS): 0 will be any pain and 10 will be the maximal perception of pain). The test will be performed with subject's eyes closed.
次要结局
- Change in patellar tendon bioimpedance(pre-intervention / baseline, immediately after the introduction the intervention needle and immediately after the intervention)
- Change in pain evoked with a transcutaneous electrical stimulus.(Pre-intervention and immediately after the intervention)
- Change in transcutaneous electrical detection threshold.(Pre-intervention and immediately after the intervention)
- Change in percutaneous electrical detection threshold.(Pre-intervention and immediately after the intervention)
- Change in maximum strength during knee extension with dynamometer(Pre-intervention and immediately after the intervention)
- International Physical Activity Questionnaire (IPAQ)(One week before the intervention)
- Pain induced during intervention(During the 16 minutes of intervention)
- Change in threshold to elicit mechanical perception with Von Frey Filaments(Pre-intervention and immediately after the intervention)
- Pain induced during bioimpedance measurement.(Immediately after the intervention, immediately after the introduction the intervention needle and immediately after of the intervention.)
- Change in pain evoked with a percutaneous electrical stimulus.(Pre-intervention and immediately after the intervention)
- Change in surface electromyography signal during knee extension(Pre-intervention and immediately after the intervention)
- Questionnaire Victorian Institute of Sport Assessment - Patella (VISA-P)(One week before intervention)
- Conditioned pain modulation(One week before the intervention)
- Questionnaire about intervention effects past 24 hours.(24 hours after the intervention)