Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy (NCT05370092) | Clinical Trial Compass
CompletedNot Applicable
Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy
Spain46 participantsStarted 2022-03-20
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.