NCT03167554

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
5.8 years until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

May 24, 2017

Last Update Submit

March 2, 2023

Conditions

ElectrolysisAchilles TendinopathyUltrasonographyPhysical Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Lower limb functionality

    10 min

  • Achilles tendon thickening

    5 min

  • Length of the most thickened area

    5 min

  • Location of the most thickened area

    5 min

Study Arms (3)

Sham group

SHAM COMPARATOR

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

Experimental group 1

EXPERIMENTAL

Electrolysis application with monopolar needle.

Other: Experimental group 1

Experimental group 2

EXPERIMENTAL

Electrolysis application with bipolar needle.

Other: Experimental group 2

Interventions

Sham comparatorOTHER

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.

Also known as: Sham group
Sham group
Experimental group 1OTHER

Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle, 330 microamps, 1 min 20 sec.

Also known as: Electrolysis application with monopolar needle.
Experimental group 1
Experimental group 2OTHER

Percutaneous Therapeutic Electrolysis (EPTE®) with bipolar needle, 120 microamps, 1 min 20 sec.

Also known as: Electrolysis application with bipolar needle.
Experimental group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Inflanta Leonor

Madrid, Spain

RECRUITING

Study Officials

  • Javier Herraiz Garvin, MSc

    Hospital Universitario Infanta Leonor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Herraiz Garvin, MSc

CONTACT

+34 687795607javierherraizfisio@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Randomized controlled clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 30, 2017

Study Start

February 28, 2023

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

March 3, 2023

Record last verified: 2023-02

Locations

ES(1)