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Ultrasound Guided Therapeutic Percutaneous Electrolysis in Achilles Tendinopathy.

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ClinicalTrials.gov Identifier: NCT03167554
Recruitment Status : Unknown
Verified February 2019 by Hospital Universitario Infanta Leonor.
Recruitment status was:  Recruiting
First Posted : May 30, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario Infanta Leonor

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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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 Name: 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 Name: 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 Name: Electrolysis application with bipolar needle.


Outcome Measures
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Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 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 :
  1. Lower limb functionality [ Time Frame: 10 min ]
    Measured by Visa-A Scale. Punctuation from 0 point up to 100 points. "0"point the most inability; "100" points complete functionality.

  2. Achilles tendon thickening [ Time Frame: 5 min ]
    Assessed by ultrasonography. Thickening was considered when the thickness is 50% greater than the contralateral limb.

  3. Length of the most thickened area [ Time Frame: 5 min ]
    Assessed by ultrasonography. Distance (in mm) between the two extremes of the thickened area

  4. Location of the most thickened area [ Time Frame: 5 min ]
    Assessed by ultrasonography. Distance (in mm) from the Achilles insertion up to the thickening onset.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167554


Contacts
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Contact: Javier Herraiz Garvin, MSc +34 687795607 javierherraizfisio@gmail.com

Locations
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Spain
Hospital Universitario Inflanta Leonor Recruiting
Madrid, Spain
Contact: Javier Herraiz Garvin, MSc    +34 687795607    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         
Sponsors and Collaborators
Hospital Universitario Infanta Leonor
Investigators
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Principal Investigator: Javier Herraiz Garvin, MSc Hospital Universitario Infanta Leonor
More Information
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Responsible Party: Hospital Universitario Infanta Leonor
ClinicalTrials.gov Identifier: NCT03167554    
Other Study ID Numbers: HUILeonor
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries