Ultrasound Guided Therapeutic Percutaneous Electrolysis in Achilles Tendinopathy.

Sponsor

Hospital Universitario Infanta Leonor (Other)

Overall Status

Recruiting

CT.gov ID

NCT03167554

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Electrolysis Achilles Tendinopathy Ultrasonography Physical Therapy	Other: Sham comparator Other: Experimental group 1 Other: Experimental group 2	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Randomized controlled clinical trial.Randomized controlled clinical trial.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain intensity [5 min]
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 [10 min]
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 [5 min]
Assessed by ultrasonography. Thickening was considered when the thickness is 50% greater than the contralateral limb.
Length of the most thickened area [5 min]
Assessed by ultrasonography. Distance (in mm) between the two extremes of the thickened area
Location of the most thickened area [5 min]
Assessed by ultrasonography. Distance (in mm) from the Achilles insertion up to the thickening onset.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Inflanta Leonor	Madrid		Spain

Sponsors and Collaborators

Hospital Universitario Infanta Leonor

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Universitario Infanta Leonor

ClinicalTrials.gov Identifier:

NCT03167554

Other Study ID Numbers:

HUILeonor

First Posted:

May 30, 2017

Last Update Posted:

Mar 18, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tendinopathy

Study Results

No Results Posted as of Mar 18, 2022