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

October 8, 2017 updated by: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Effectiveness of the Inclusion of US-guided Percutaneous Electrolysis (EPE®) in Subacromial Pain Syndrome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcorcon, Madrid, Spain, 28921
        • César Fernández-de-las-Peñas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Other: 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.
ACTIVE_COMPARATOR: 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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in disability before and after the intervention
Time Frame: Baseline, one week after the last session, 3 months and 6 months after the last session
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
Baseline, one week after the last session, 3 months and 6 months after the last session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in pain intensity before and after the intervention
Time Frame: Baseline, one week after the last session, 3 months and 6 months after the last session
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area.
Baseline, one week after the last session, 3 months and 6 months after the last session
Changes in functionality before and after the intervention
Time Frame: Baseline, one week after the last session, 3 months and 6 months after the last session
The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain
Baseline, one week after the last session, 3 months and 6 months after the last session
Changes in pressure pain sensitivity before and after the intervention
Time Frame: Baseline, one week after the last session, 3 months and 6 months after the last session
Pressure pain thresholds will be assessed over the cervical spine, the hand, the deltoid muscle and the tibialis muscle
Baseline, one week after the last session, 3 months and 6 months after the last session
Self-perceived improvement
Time Frame: Baseline, one week after the last session, 3 months and 6 months after the last session
A Global Rating of Change (GROC) from -7 (a very great deal worse) to +7 (a very great deal better) will be used to assess self-perceived improvement
Baseline, one week after the last session, 3 months and 6 months after the last session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Rey Juan Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • URJC 08-2015

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