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Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy

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ClinicalTrials.gov Identifier: NCT02196948
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, 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

Condition or disease Intervention/treatment Phase
Supraspinatus Tendinopathy Other: Electrolysis Percutaneous Therapeutic (EPTE) Other: Eccentric exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrolysis Percutaneous Therapeutic (EPTE) for the Management of Supraspinatus Tendinopathy
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

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



Primary Outcome Measures :
  1. Changes in pain intensity before and after the intervention [ Time Frame: 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 :
  1. Changes in disability before and after the intervention [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196948


Locations
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Spain
Universidad Rey Juan Carlos
Alcorcon, Madrid, Spain, 28922
Sponsors and Collaborators
Universidad Rey Juan Carlos
Investigators
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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

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Responsible Party: César Fernández-de-las-Peñas, Proffesor, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT02196948     History of Changes
Other Study ID Numbers: URJC 22/2014
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by César Fernández-de-las-Peñas, Universidad Rey Juan Carlos:
Supraspinatus, tendinopathy, pain, disability, EPTE

Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries