Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy

NCT02196948 | Completed DMC

• 1 other identifier: URJC 22/2014
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Supraspinatus Tendinopathy

Keywords

Supraspinatus, tendinopathy, pain, disability, EPTE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in disability before and after the intervention

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

Study Arms (2)

Electrolysis Percutaneous Therapeutic (EPTE)

EXPERIMENTAL

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)

Eccentric exercise

EXPERIMENTAL

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

Interventions

Electrolysis Percutaneous Therapeutic (EPTE) OTHER

Electrolysis Percutaneous Therapeutic (EPTE)

Eccentric exercise OTHER

Eccentric exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Tendinopathy; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: July 19, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

ES (1)