search
Back to results

Ultrasound Guided Therapeutic Percutaneous Electrolysis in Achilles Tendinopathy.

Primary Purpose

Electrolysis, Achilles Tendinopathy, Ultrasonography

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sham comparator
Experimental group 1
Experimental group 2
Sponsored by
Hospital Universitario Infanta Leonor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electrolysis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Inflanta LeonorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Sham group

Experimental group 1

Experimental group 2

Arm Description

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.

Electrolysis application with monopolar needle.

Electrolysis application with bipolar needle.

Outcomes

Primary Outcome Measures

Pain intensity
Measured by Numeric Pain Rating Scale. Punctuation from 0 point up to 10 points. "0" no pain; "10" the most bearable pain.

Secondary Outcome Measures

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.
Achilles tendon thickening
Assessed by ultrasonography. Thickening was considered when the thickness is 50% greater than the contralateral limb.
Length of the most thickened area
Assessed by ultrasonography. Distance (in mm) between the two extremes of the thickened area
Location of the most thickened area
Assessed by ultrasonography. Distance (in mm) from the Achilles insertion up to the thickening onset.

Full Information

First Posted
May 24, 2017
Last Updated
March 2, 2023
Sponsor
Hospital Universitario Infanta Leonor
search

1. Study Identification

Unique Protocol Identification Number
NCT03167554
Brief Title
Ultrasound Guided Therapeutic Percutaneous Electrolysis in Achilles Tendinopathy.
Official Title
Effectiveness of Therapeutic Percutaneous (EPTE®) Guided by Ultrasound as a Treatment of Achilles Tendinopathy. A Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario Infanta Leonor

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electrolysis, Achilles Tendinopathy, Ultrasonography, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomized controlled clinical trial.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
Electrolysis application with monopolar needle.
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
Electrolysis application with bipolar needle.
Intervention Type
Other
Intervention Name(s)
Sham comparator
Other Intervention Name(s)
Sham group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental group 1
Other Intervention Name(s)
Electrolysis application with monopolar needle.
Intervention Description
Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle, 330 microamps, 1 min 20 sec.
Intervention Type
Other
Intervention Name(s)
Experimental group 2
Other Intervention Name(s)
Electrolysis application with bipolar needle.
Intervention Description
Percutaneous Therapeutic Electrolysis (EPTE®) with bipolar needle, 120 microamps, 1 min 20 sec.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Measured by Numeric Pain Rating Scale. Punctuation from 0 point up to 10 points. "0" no pain; "10" the most bearable pain.
Time Frame
5 min
Secondary Outcome Measure Information:
Title
Lower limb functionality
Description
Measured by Visa-A Scale. Punctuation from 0 point up to 100 points. "0"point the most inability; "100" points complete functionality.
Time Frame
10 min
Title
Achilles tendon thickening
Description
Assessed by ultrasonography. Thickening was considered when the thickness is 50% greater than the contralateral limb.
Time Frame
5 min
Title
Length of the most thickened area
Description
Assessed by ultrasonography. Distance (in mm) between the two extremes of the thickened area
Time Frame
5 min
Title
Location of the most thickened area
Description
Assessed by ultrasonography. Distance (in mm) from the Achilles insertion up to the thickening onset.
Time Frame
5 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Herraiz Garvin, MSc
Phone
+34 687795607
Email
javierherraizfisio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Herraiz Garvin, MSc
Organizational Affiliation
Hospital Universitario Infanta Leonor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Inflanta Leonor
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Herraiz Garvin, MSc
Phone
+34 687795607
Email
javier.herraiz@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Irene de la Rosa Diaz, Dr
First Name & Middle Initial & Last Name & Degree
Ester Sanchez Rodriguez, MSc
First Name & Middle Initial & Last Name & Degree
Rosalia de Dios Alvarez, Dr
First Name & Middle Initial & Last Name & Degree
Natividad Plaza Andreu, Dr
First Name & Middle Initial & Last Name & Degree
Manuel Benito Junquera, MSc
First Name & Middle Initial & Last Name & Degree
Gema Lendinez Burgos, MSc
First Name & Middle Initial & Last Name & Degree
Elena Barcina Garica, Dr
First Name & Middle Initial & Last Name & Degree
Rosa Lorente Ramos, Dr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Ultrasound Guided Therapeutic Percutaneous Electrolysis in Achilles Tendinopathy.

We'll reach out to this number within 24 hrs