Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy

Electrolysis Percutaneous Therapeutic (EPTE) for the Management of Supraspinatus Tendinopathy

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

Study Overview

• Status: Completed
• Conditions: Supraspinatus Tendinopathy
• Intervention / Treatment: Other: Eccentric exercise; Other: Electrolysis Percutaneous Therapeutic (EPTE)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Universidad Rey Juan Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Electrolysis Percutaneous Therapeutic (EPTE)
Experimental: 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.	Other: Eccentric exercise

What is the study measuring?

Primary 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, after 2 weeks of treatment and one week after the last session

Secondary 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, after 2 weeks of treatment and one week after the last session

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: Jose Luis Arias Buría, PT, MSc, Hospital Universitario Gregorio Marañón-Universidad Rey Juan Carlos; Principal Investigator: César Fernández de las Peñas, PT, PhD, Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 19, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Supraspinatus, tendinopathy, pain, disability, EPTE
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: URJC 22/2014