Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy

Not Applicable

Completed

• Conditions: Supraspinatus Tendinopathy
• Interventions: Other: Electrolysis Percutaneous Therapeutic (EPTE); Other: Eccentric exercise

• Registration Number: NCT02196948
• Lead Sponsor: Universidad Rey Juan Carlos

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-19
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrolysis Percutaneous Therapeutic (EPTE)	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.
Eccentric exercise	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.

Primary Outcome Measures

Name	Time	Method
Changes in pain intensity before and after the intervention	Baseline, after 2 weeks of treatment and one week 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.

Secondary Outcome Measures

Name	Time	Method
Changes in disability before and after the intervention	Baseline, after 2 weeks of treatment and one week after the last session	The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Alcorcon, Madrid, Spain