Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy (PNE)

October 31, 2022 updated by: Antonio Rejas Fenández, Universidad Rey Juan Carlos

Effect of Percutaneous Needle Electrolysis on Tibialis Posterior 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 weeks
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group

Patients assigned to this group will receive a session of manual therapy and therapeutic exercise. The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).

The therapeutic exercise session participants will perform 2 exercises for 4 weeks 3 days per week. 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. Each exercise will be performed in 3 series of 15 repetitions, with 1 minute rest between series, the exercise session will follow the TM and will last approximately 15-20 minutes.
Other: Therapeutic exercise
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
Other: Manual therapy
The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).
Experimental: Intervention group

Participants in this group will receive 4 sessions (once a week during their respective treatment session) of percutaneous electrolysis guided by MUSCULO-SKELETAL ECOGRAPHY, by a physiotherapist with extensive clinical experience in this therapeutic approach. The technique will be applied using a specifically developed and medically certified device (EPI Advanced Medicine®, Barcelona, Spain. EPI®). The galvanic current will be applied using acupuncture needles. In the present study, a 0.30*25 mm needle (Agupunt, Barcelona, Spain) will be used, with an intensity of 2 mA for a total of 3-5 seconds and 3-5 impacts on the liquid content (TTP tenosynovitis) and 2 mA for a total of 3 seconds and 2-3 impacts if in the tendon (intrasubstance). The technique shall be applied under ultrasound guidance.

The needle shall be introduced at an angle of 80° in a short-axis cross-section to the skin, with the tip of the needle directed towards the posterior tibial tendon.
Other: Therapeutic exercise
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
Other: Manual therapy
The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).
Other: Percutaneous needle electrolysis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NUMERICAL SCALE OF PAIN (NSP)
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. The objective of the scale is to reduce the patient's pain with the intervention and that the pain that he gives us at the beginning, prior to the intervention, decreases until it reaches 0.
6 months
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.
6 months
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. We will take as reference the pre-intervention measurement in millimeters and the post-intervention measurement to see if the tendon has undergone changes in its size.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Rey Juan Carlos

Investigators

  • Principal Investigator: Antonio Rejas Fernández, Universidad Rey Juan Carlos
  • Study Director: Jose Luis Arias Buría, Universidad Rey Juan Carlos
  • Study Director: Ana Isabel De La Llave Rincón, Universidad Rey Juan Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1801202201622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Posterior Tibial Tendon Dysfunction

Clinical Trials on Therapeutic exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe