Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy

Supraspinatus Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196948
• Other study ID #: URJC 22/2014
• Status: Completed
• Phase: N/A
• First received: July 19, 2014
• Last updated: December 2, 2014
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Supraspinatus Tendinopathy
• Tendinopathy

Intervention

Other:
• Electrolysis Percutaneous Therapeutic (EPTE)

• Eccentric exercise

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes