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Completed

NCT Number: NCT05370092

Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy

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.

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Key information

Conditions

Posterior Tibial Tendon Dysfunction Foot Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Rey Juan Carlos

Madrid, 28933, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

percutaneous needle electrolysis

Other

Electrolysis is the process by which water (H2O) and sodium chloride (NaCl) molecules, which are present in the biological tissues and body compartments of our organism, are organically broken down into their constituent chemical elements, regrouping to create entirely new substances such as sodium hydroxide (NaOH), hydrogen gas (H2) and chlorine gas (Cl2). This process occurs thanks to the passage of a flow of direct electric current, also known as galvanic current, which is a totally athermal process. The passage of this current allows a local inflammatory response to occur (increase in lymphocytes and macrophages) as well as an increase in vasodilatation, inducing phagocytosis and biological stimulation of tendon repair.

Therapeutic exercise

Other

The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase

Manual therapy

Other

The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).

Primary outcomes

  1. NUMERICAL PAIN RATE SCALE (NPRS. 0-10)

    Time frame: 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.

Secondary outcomes

  1. FOOT AND ANKLE ABILITY (FAAM)

    Time frame: 6 months

    The FAAM questionnaire consists of 29 items separated into two subscales: the ADL subscale with 21 items and the Sport subscale with 8 items. Each one has a maximum Likert scale score of 5 points ranging from "no difficulty" to "impossible to perform". All scores will be converted to percentages, with a higher percentage indicating a higher level of functionality and lower pathology. At the end of the scale, the functionality percentage will be calculated, ranging from 0% (inability to perform any activity) to 100% (normal functionality level). Finally, patients will rate the condition of their ankle and foot on a 4-point scale that includes "normal," "almost normal," "abnormal," and "severely abnormal." The intention of the study is that the patient recovers 100% of functionality or better the percentage that has been marked prior to the intervention. As in the 4-point scale, the condition of your ankle should be normal.

Other outcomes

  1. ULTRASOUND CONTROL

    Time frame: 4 weeks

    All participants, both in the control and experimental groups, will be examined before the intervention and at the end of the 4 sessions to evaluate possible changes in the tendon, and all invasive interventions will be performed ultrasonographically. This measurement was just a qualitative control of the diagnosis of tendinopathy.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Effect of Percutaneous Needle Electrolysis on Tibialis Posterior Tendinopathy

Acronym: PNE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 11, 2022
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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