US-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain

NCT ID: NCT02569281

Last Updated: 2017-10-10

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-09-30

Brief Summary

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Scientific evidence of conservative management of subacromial pain syndrome is conflicting. There is evidence that eccentric exercise programs are effective at medium term for this pain condition. The inclusion of other therapeutic modalities is still controversial. A recent study suggests that the inclusion of US-guided percutaneous electrolysis combined with eccentric exercises can be effective at short-term for this condition. The objective of this randomized clinical trial is to determine the effectiveness at short- and long-term of the inclusion of US-guided percutaneous electrolysis (EPE®) into a eccentric exercise protocol for the management of patients with subacromial pain syndrome for pain, function, disability and pressure pain sensitivity.

Detailed Description

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Conditions

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Shoulder Pain

Keywords

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Subacromial pain syndrome Eccentric exercise Pressure pain US-guided percutaneous electrolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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US-guided percutaneous electrolysis

Patients will receive one weekly session for 5 weeks including best-evidence manual therapy and an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles. The exercise program will be asked to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. In addition, they will receive one session of US-guided percutaneous electrolysis. This intervention consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon.

Group Type EXPERIMENTAL

US-guided percutaneous electrolysis

Intervention Type OTHER

US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon.

Eccentric exercise

Patients will receive one weekly session for 5 weeks including best-evidence manual therapy and an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles. The exercise program will be asked to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.

Group Type ACTIVE_COMPARATOR

Eccentric exercise

Intervention Type OTHER

An eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles will be learned by the patients allocated to this group

Interventions

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US-guided percutaneous electrolysis

US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon.

Intervention Type OTHER

Eccentric exercise

An eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles will be learned by the patients allocated to this group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* unilateral shoulder complaints with duration of at least 3 months;
* an intensity of at least 4 on an 11-point numerical pain rating scale (NPRS) during arm elevation;
* a positive painful arc test during abduction
* at least one positive of the following tests: Hawkins-Kennedy test, Neer's sig, empty can test, drop arm or lift-off test

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

60 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

Head Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, Spain

Site Status

Countries

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Spain

References

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de Miguel Valtierra L, Salom Moreno J, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL. Ultrasound-Guided Application of Percutaneous Electrolysis as an Adjunct to Exercise and Manual Therapy for Subacromial Pain Syndrome: A Randomized Clinical Trial. J Pain. 2018 Oct;19(10):1201-1210. doi: 10.1016/j.jpain.2018.04.017. Epub 2018 May 16.

Reference Type DERIVED
PMID: 29777953 (View on PubMed)

Other Identifiers

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URJC 08-2015

Identifier Type: -

Identifier Source: org_study_id