Application of Percutaneous Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise

NCT ID: NCT03184181

Last Updated: 2023-05-10

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-02-01

Brief Summary

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The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of awareness about the options of the physiotherapist treatment. It is necessary to do studies about effectiveness of therapeutic percutaneous electrolysis (EPTE®). This technique enables treatment of the tendinopathies and the broken muscle fibrilare. It is base on the application of galvanic current through a acupuncture needle. To analyze the effectiveness of therapeutic percutaneous electrolysis (EPTE®) in the treatment of supraspinatus muscle tendinopathy. Single center randomized controlled trial, parallel treatment design. A specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants will be randomly assigned to receive treatmen for 4 weeks: EPTE® associated with eccentric exercises or dry needling with the same eccentric exercises. Both interventions were performed under ultrasound guidance with a portable ultrasound (General Electric LogicE). Data will be collected by a blinded evaluator.

Detailed Description

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Eccentric exercises of the supraspinatus muscle were performed in 3 sets of 10 repetitions. Participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the supraspinatus, infraspinatus, and scapular muscles. Participants were asked to do a normal abduction (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. The exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.

Conditions

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Supraspinatus Tendinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A specialist physician will be diagnosed the supraspinatus tendinopathy.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EPTE® group

The intervention for this group consisted of Therapeutic Percutaneous Electrolysis (EPTE®). Patient received EPTE® once week for four weeks associated with eccentric exercises device at home.

Group Type EXPERIMENTAL

EPTE® group

Intervention Type OTHER

Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.

Dry needling group

The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises device at home. Patient received 3 sessions of dry needling a week for four weeks.

Group Type ACTIVE_COMPARATOR

Dry needling group

Intervention Type OTHER

The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.

Interventions

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EPTE® group

Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.

Intervention Type OTHER

Dry needling group

The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.

Intervention Type OTHER

Other Intervention Names

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EPTE + EXER DN + EXER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with supraspinatus tendinopathies that do not improve with conventional physiotherapy or pharmacological therapy protocols.
* Subjects who are in an active state of pain, who present painful symptoms in a sensitive and painful area of the tendon of insertion of the supraspinatus muscle in the humerus.

Exclusion Criteria

* Individuals who have received surgery intervention in the same shoulder, or have suffered fractures or dislocations in the same shoulder.
* Individuals have received the proposed treatment in one month´s period previously.
* Individuals who suffering from cervical radiculopathies, fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
* Pregnant women can not receive this treatment intervention.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jorge Manuel Góngora Rodriguez

UNKNOWN

Sponsor Role collaborator

Manuel Rodriguez Huguet

UNKNOWN

Sponsor Role collaborator

Pablo Rodriguez Huguet

UNKNOWN

Sponsor Role collaborator

Rocío Martín Valero

UNKNOWN

Sponsor Role collaborator

University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Manuel Rodriguez Huguet

Degree Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Manuel, BSc

Role: PRINCIPAL_INVESTIGATOR

University of Cadiz

Locations

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Policlínica Santa María

Cadiz, Cádiz, Spain

Site Status

Countries

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Spain

References

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Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.

Reference Type BACKGROUND
PMID: 26649058 (View on PubMed)

Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.

Reference Type BACKGROUND
PMID: 19297202 (View on PubMed)

Other Identifiers

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168/16

Identifier Type: -

Identifier Source: org_study_id

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