Effectiveness of the Ultrasound-guided Percutaneous Neuromodulation Technique in Post-surgical Anterior Cruciate Ligament Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes in pain through the visual analogue scale in 12 weeks
研究概览
简要总结
The objective of the study is to demonstrate the efficacy of the ultrasound-guided percutaneous neuromodulation technique in the femoral nerve in patients who underwent surgery for the anterior cruciate ligament.
详细描述
After being informed about the study and the potential risks, all subjects who accept the study and give their informed consent in writing, the subjects will participate in a randomized, longitudinal and prospective clinical trial divided into two groups (control group and experimental group) with the main objective of demonstrating that the ultrasound-guided percutaneous neuromodulation technique is effective for the treatment of pain in subjects undergoing surgery for the anterior cruciate ligament.
Subjects belonging to the control group will perform a physiotherapy protocol and those belonging to the experimental group will undergo two interventions of the ultrasound-guided percutaneous neuromodulation technique combined with the physiotherapy protocol. The same number of measurements will be performed on all subjects.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 18 and 55 years who have undergone surgery for an anterior cruciate ligament (ACL) in a period of time between 2 and 6 weeks of evolution with or without meniscal injury (meniscal regularization / meniscal suture / meniscectomy, etc.).
- •have pain or loss of sensitivity in the operated knee and that they have signed the informed consent.
排除标准
- •Subjects with chronic joint disease; prosthesis or osteosynthesis in the intervention area, as well as heart disease, neoplasia and coagulopathy.
- •Subjects consuming analgesics.
- •Subjects with belonephobia or insurmountable fear of needles
- •History of lumbar pathology (lumbar hernia/protrusion) due to possible involvement of the lumbar plexus.
- •Subjects with a history of neurological or orthopedic disorders
- •Subjects with bilateral symptoms.
- •Subjects with epilepsy, pacemaker or pregnant.
结局指标
主要结局
Changes in pain through the visual analogue scale in 12 weeks
时间窗: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
It allows pain intensity to be measured with maximum reproducibility between observers. It consists of a horizontal line of 10 centimeters, at whose ends are the extreme expressions of a symptom. Absence or less intensity is located on the left and greater intensity on the right. The patient is asked to mark the point on the line that indicates the intensity and it is measured with a millimeter ruler. This variable will be measured with a numerical value from 1 to 10.
次要结局
- Changes in range of movement in 12 weeks.(Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,)
- Changes in dynamometry in 12 weeks.(Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,)
- Changes in pressure pain threshold in 12 weeks(Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,)
- Changes in LEFS scale in 12 weeks(Before treatment / intervention and week 12.)
- Changes in DN4 scale en 12 weeks(Before treatment / intervention and week 12.)
- Changes in heart rate variability in 12 weeks(Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,)
- Body Mass Index(Before treatment / intervention)