Back to resultsElectrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy
Primary Purpose
Supraspinatus Tendinopathy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Electrolysis Percutaneous Therapeutic (EPTE)
Eccentric exercise
Sponsored by
About this trial
This is an interventional treatment trial for Supraspinatus Tendinopathy focused on measuring Supraspinatus, tendinopathy, pain, disability, EPTE
Eligibility 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
Sites / Locations
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Electrolysis Percutaneous Therapeutic (EPTE)
Eccentric exercise
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02196948
First Posted
July 19, 2014
Last Updated
December 2, 2014
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02196948
Brief Title
Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy
Official Title
Electrolysis Percutaneous Therapeutic (EPTE) for the Management of Supraspinatus Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraspinatus Tendinopathy
Keywords
Supraspinatus, tendinopathy, pain, disability, EPTE
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrolysis Percutaneous Therapeutic (EPTE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Eccentric exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electrolysis Percutaneous Therapeutic (EPTE)
Intervention Type
Other
Intervention Name(s)
Eccentric exercise
Primary Outcome Measure Information:
Title
Changes in pain intensity before and after the intervention
Description
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.
Time Frame
Baseline, after 2 weeks of treatment and one week after the last session
Secondary Outcome Measure Information:
Title
Changes in disability before and after the intervention
Description
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
Time Frame
Baseline, after 2 weeks of treatment and one week after the last session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Luis Arias Buría, PT, MSc
Organizational Affiliation
Hospital Universitario Gregorio Marañón-Universidad Rey Juan Carlos
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
César Fernández de las Peñas, PT, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy
We'll reach out to this number within 24 hrs