Effect of Percutaneous Needle Electrolysis on Tibialis Posterior Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- NUMERICAL PAIN RATE SCALE (NPRS. 0-10)
研究概览
简要总结
The aim of this study is to test the efficacy of percutaneous electrolysis in posterior tibial tendinopathies. The posterior tibial tendon injury is one of the most frequent pathologies in the lower extremities, and therefore a correct study and evaluation of it is necessary. This study aims to compare the therapeutic effect of percutaneous electrolysis comparing a control group with an experimental group. To evaluate functionality, pain and its ultrasound pattern before and after treatment, in order to assess the efficacy of the treatment.
详细描述
A single-blind, longitudinal, randomised, controlled, single-blind, longitudinal, randomised, controlled clinical trial will be conducted. First, the participant will receive a FOOT AND ANKLE ABILITY (FAAM) survey, along with a numerical pain scale, both of which must be completed. Next, an ultrasound study of the foot will be performed, focusing on pain in the inner ankle, to check for possible pathology in the posterior tibial tendon. Finally, the physiotherapist's intervention will be carried out to check the effectiveness of the technique, which may cause some pain, and finally, the numerical pain scale will be passed again. Four sessions will be carried out in four different weeks, always using the same day of the week for the intervention and following the same steps as above. The purpose of this study is to test the efficacy of PD in posterior tibial tendinopathy and whether PD is therefore a safe technique for this type of intervention. All patients will sign an informed consent form and will be informed about the study beforehand.
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
- Single (Participant)
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
- •Subjects over 18 years of age
- •Mild inflammation, swelling and/or tenderness posterior to the medial malleolus
- •Pain posterior and/or superior to the medial malleolus, aggravated by activity
- •Pain present for at least 3 months
- •One or more signs of flexible flatfoot deformity, including excessive valgus deformity of the hindfoot during weight bearing and/or excessive foot abduction (many toes sign).
- •Pain when performing the Hell Rise Test or performed incorrectly.
- •Signs of tenosynovitis on ultrasound examination.
- •As the inclusion criteria are based on side-to-side comparison all participants had to have unilateral involvement.
排除标准
- •Previous surgery on the affected foot, leg or knee.
- •Disabling osteoarthritis of the knee on the affected side.
- •Fixed hindfoot deformities.
- •Recurrent ankle sprains on the affected side.
- •Ligament tears or bony abnormalities of the affected foot.
- •A physical or medical condition that contraindicates the testing protocol.
- •Pregnancy.
- •FCD or FLH tendinopathy.
结局指标
主要结局
NUMERICAL PAIN RATE SCALE (NPRS. 0-10)
时间窗: 6 months
The scale consists of a horizontal line of 11 numbers, at the ends of which are the extreme manifestations of a symptom that allows observers to measure the intensity of pain with maximum reproducibility. On the far left is 0 or the total absence of pain and on the far right is 10 or the maximum pain that can be tolerated. The patient will be asked to select the number where they consider their pain to be.
次要结局
- FOOT AND ANKLE ABILITY (FAAM)(6 months)
研究者
Antonio Rejas Fenández
Principal Investigator
Universidad Rey Juan Carlos