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Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy

NCT ID: NCT02196948

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-12-31

Brief Summary

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Therapeutic management of supraspinatus tendinopathy is conflicting. There is evidence that eccentric exercise protocols can be effective for this condition. The inclusion of other therapeutic modalities could help to the management of these patients. A new therapeutic approach, called Electrolysis Percutaneous Therapeutic (EPTE) has been clinically developed. The objective of this randomized clinical trial is to determine the effectiveness of the inclusion of EPTE into a eccentric exercise protocol for the management of patients with unilateral supraspinatus tendinopathy

Detailed Description

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Conditions

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Supraspinatus Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Electrolysis Percutaneous Therapeutic (EPTE)

Electrolysis Percutaneous Therapeutic (EPTE) consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon, to initiate a local inflammatory process allowing phagocytosis and repair of the affected tissue. The technique is pain-free since the electrical intensity is adapted to each patient. In addition, patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 4 weeks.

Group Type EXPERIMENTAL

Electrolysis Percutaneous Therapeutic (EPTE)

Intervention Type OTHER

Eccentric exercise

Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 4 weeks.

Group Type EXPERIMENTAL

Eccentric exercise

Intervention Type OTHER

Interventions

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Electrolysis Percutaneous Therapeutic (EPTE)

Intervention Type OTHER

Eccentric exercise

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Unilateral supraspinatus tendinopathy
* Shoulder pain from at least 3 months
* Shoulder pain of more than 4 points on a NPRS
* Positive findings of supraspinatus tendinopathy on MRI

Exclusion Criteria

* bilateral shoulder symptoms
* younger than 18 or older than 65 years
* history of shoulder fractures or dislocation
* cervical radiculopathy
* previous interventions with steroid injections
* fibromyalgia syndrome
* previous history of shoulder or neck surgery
* any type of intervention for the neck-shoulder area during the previous year
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

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César Fernández-de-las-Peñas

Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose Luis Arias Buría, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Gregorio Marañón-Universidad Rey Juan Carlos

César Fernández de las Peñas, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Rey Juan Carlos

Locations

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Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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URJC 22/2014

Identifier Type: -

Identifier Source: org_study_id