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

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: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: US-guided percutaneous electrolysis; Other: Eccentric exercise

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Changes in disability before and after the intervention	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

Outcome Measure	Measure Description	Time Frame
Changes in pain intensity before and after the intervention	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	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	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	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

• Sponsor: Universidad Rey Juan Carlos

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: October 2, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (ESTIMATE): October 6, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2017
• Last Update Submitted That Met QC Criteria: October 8, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Eccentric exercise; Pressure pain; Subacromial pain syndrome; US-guided percutaneous electrolysis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: URJC 08-2015