Ultrasound Guided Therapeutic Percutaneous Electrolysis in Achilles Tendinopathy.

Effectiveness of Therapeutic Percutaneous (EPTE®) Guided by Ultrasound as a Treatment of Achilles Tendinopathy. A Randomized Controlled Clinical Trial.

Achilles tendon is a frequent lower-limb tissue where tendinopathy may arise. Percutaneous Therapeutic Electrolysis (EPTE®) is an electronic device that enables to treat accurately, guided by an ultrasound, the tendon injured area by applying a galvanic current through an acupuncture needle. Thus, the first stage of physiological regenerative process may be obtained. Design: Randomized Controlled Clinical Trial. Objectives: To know the effectiveness of Percutaneous Therapeutic Electrolysis (EPTE®) versus a sham intervention at improving pain and function in patients who undergo Achilles Chronic Tendinopathy and to determine the efficiency of Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle versus Percutaneous Therapeutic Electrolysis (EPTE®) with bipolar needle at improving pain and function in patients who undergo Achilles Chronic Tendinopathy. Participants: patients diagnosed with Achilles Chronic Tendinopathy. Setting. Infanta Leonor Hospital, Madrid, Spain. Experimental intervention: Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle, 330 microamps, 1 min 20 sec versus bipolar needle. Sham intervention: the guide tube of the needle contacted with the skin and the device remained switched on to simulate its functioning.

Study Overview

• Status: Recruiting
• Conditions: Ultrasonography; Physical Therapy; Achilles Tendinopathy; Electrolysis
• Intervention / Treatment: Other: Sham comparator; Other: Experimental group 1; Other: Experimental group 2

Detailed Description

Tendinopathy is a common injury among athletes, where the incidence reaches 50%. Nevertheless, industrial workers as well as sedentary subjects may also undergo this pain condition.

Achilles tendon is a frequent lower-limb tissue where tendinopathy may arise. Achilles tendinopathy risk factors have been detailed, such as: age, mechanical axis deviation of lower limbs, excessive training load dosage, and type of work activity. The middle portion of the tendon is the area where Achilles tendinopathy is most likely to be located. Interestingly, correlation between pain severity and the degree of tissue degeneration by imaging diagnosis is hardly showed in chronic tendinopathy conditions. Thus, chronic tendinopathy pain may be mediated not only by peripheral but by central mechanisms.

Percutaneous Therapeutic Electrolysis (EPTE® System; Manual EPTE, 2014 IONCLINICS & DEIONIC, S.L.) is an electronic device that enables to treat accurately, guided by an ultrasound, the tendon injured area by penetrating the skin with an acupuncture needle. A galvanic current goes through the device to the needle so that the first stage of physiological regenerative process may be obtained. That is due to a chemical reaction that leads to a controlled alkaline burn into the injured tissue and a subsequent basification of extracellular medium. That elicits an inflammatory response; the destroyed tissue is metabolized by phagocytosis process. Design: Randomized Controlled Clinical Trial. Objectives: To know the effectiveness of Percutaneous Therapeutic Electrolysis (EPTE®) versus a sham intervention at improving pain and function in patients who undergo Achilles Chronic Tendinopathy, and to determine the efficiency of Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle versus Percutaneous Therapeutic Electrolysis (EPTE®) with bipolar needle at improving pain and function in patients who undergo Achilles Chronic Tendinopathy. Participants: patients diagnosed with Achilles Chronic Tendinopathy. Setting. Infanta Leonor Hospital, Madrid, Spain. Experimental intervention: Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle, 330 microamps, 1 min 20 sec versus bipolar needle. Sham intervention: the guide tube of the needle contacted with the skin and the electrolysis device remained switched on to simulate its functioning.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javier Herraiz Garvin, MSc; Phone Number: +34 687795607; Email: javierherraizfisio@gmail.com

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario Inflanta Leonor
    • Contact: Javier Herraiz Garvin, MSc; Phone Number: +34 687795607; Email: javier.herraiz@salud.madrid.org
    • Sub-Investigator: Irene de la Rosa Diaz, Dr
    • Sub-Investigator: Ester Sanchez Rodriguez, MSc
    • Sub-Investigator: Rosalia de Dios Alvarez, Dr
    • Sub-Investigator: Natividad Plaza Andreu, Dr
    • Sub-Investigator: Manuel Benito Junquera, MSc
    • Sub-Investigator: Gema Lendinez Burgos, MSc
    • Sub-Investigator: Elena Barcina Garica, Dr
    • Sub-Investigator: Rosa Lorente Ramos, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Achilles Chronic Tendinopathy diagnosis (from 3months up to 3 years)

Exclusion Criteria:

• Physical therapy treatment within the last 4 months.
• Surgery approach for Achilles tendinopathy.
• Pregnancy
• Corticoid treatment in the last 4 months.
• Pacemaker
• Thrombophlebitis
• Systemic disease
• Cognitive disease
• Prosthesis or osteosynthesis
• Dermatopathies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham group; Simulating of the electrolysis application.he electrolysis technique was simulated to be delivered. The guide tube of the needle contacted with the skin, located on the painful area, and the device remained switched on to simulate its functioning.	Other: Sham comparator; The electrolysis technique was simulated to be delivered. The guide tube of the needle contacted with the skin, located on the painful area, and the device remained switched on to simulate its functioning.; Other Names: Sham group
Experimental: Experimental group 1; Electrolysis application with monopolar needle.	Other: Experimental group 1; Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle, 330 microamps, 1 min 20 sec.; Other Names: Electrolysis application with monopolar needle.
Experimental: Experimental group 2; Electrolysis application with bipolar needle.	Other: Experimental group 2; Percutaneous Therapeutic Electrolysis (EPTE®) with bipolar needle, 120 microamps, 1 min 20 sec.; Other Names: Electrolysis application with bipolar needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Measured by Numeric Pain Rating Scale. Punctuation from 0 point up to 10 points. "0" no pain; "10" the most bearable pain.	5 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower limb functionality	Measured by Visa-A Scale. Punctuation from 0 point up to 100 points. "0"point the most inability; "100" points complete functionality.	10 min
Achilles tendon thickening	Assessed by ultrasonography. Thickening was considered when the thickness is 50% greater than the contralateral limb.	5 min
Length of the most thickened area	Assessed by ultrasonography. Distance (in mm) between the two extremes of the thickened area	5 min
Location of the most thickened area	Assessed by ultrasonography. Distance (in mm) from the Achilles insertion up to the thickening onset.	5 min

Collaborators and Investigators

• Sponsor: Hospital Universitario Infanta Leonor
• Investigators: Principal Investigator: Javier Herraiz Garvin, MSc, Hospital Universitario Infanta Leonor

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: HUILeonor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No