Supraspinatus TendinopathyNCT02196948
Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy
A study testing Electrolysis Percutaneous Therapeutic (EPTE) and Eccentric exercise in people with Supraspinatus Tendinopathy, run by Universidad Rey Juan Carlos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Supraspinatus Tendinopathy
- What is being tested?
- Electrolysis Percutaneous Therapeutic (EPTE) and Eccentric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrolysis Percutaneous Therapeutic (EPTE) for the Management of Supraspinatus Tendinopathy
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
- Being tested
- Electrolysis Percutaneous Therapeutic (EPTE), Eccentric exercise
- Keywords
- Supraspinatus, tendinopathy, pain, disability, EPTE
- Medical subject headings
- Tendinopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrolysis Percutaneous Therapeutic (EPTE)Other
Eccentric exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after 2 weeks of treatment and one week after the last session
Secondary outcomes (1)
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
Measured: Baseline, after 2 weeks of treatment and one week after the last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- Jose Luis Arias Buría, PT, MSc, Principal investigator, Hospital Universitario Gregorio Marañón-Universidad Rey Juan CarlosCésar Fernández de las Peñas, PT, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196948
- Sponsor's protocol ID
- URJC 22/2014
- Status last verified
- Dec 2014
- First submitted
- 19 Jul 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrolysis Percutaneous Therapeutic (EPTE) for the Management of Supraspinatus Tendinopathy
- ClinicalTrials.gov ID
- NCT02196948
- Acronym / sponsor ID
- URJC 22/2014
- Conditions
- Supraspinatus Tendinopathy
- Keywords
- Supraspinatus, tendinopathy, pain, disability, EPTE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrolysis Percutaneous Therapeutic (EPTE) | Experimental | Other: 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 | Experimental | Other: Eccentric exercisePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- bilateral shoulder symptoms
- younger than 18 or older than 65 years
- history of shoulder fractures or dislocation
- cervical radiculopathy
- previous interventions with steroid injections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrolysis Percutaneous Therapeutic (EPTE) | Other | Electrolysis Percutaneous Therapeutic (EPTE) |
| Eccentric exercise | Other | Eccentric exercise |
Primary outcome
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.
1 secondary outcome
Changes in disability before and after the intervention
Time frame: Baseline, after 2 weeks of treatment and one week after the last session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
Related trials for Supraspinatus Tendinopathy
Recruiting
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Active, not recruiting
Subacromial Corticosteroid Injection Combined With Exercise in Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Not yet recruiting
Effects of Aerobic Exercise on Shoulder Pain, Disability, and Ultrasonographic Outcomes in Patients With Type 2 Diabetes Mellitus With Supraspinatus Tendinopathy
Supraspinatus Tendinopathy, Type 2 Diabetes Mellitus (T2DM)
Recruiting
Intralesional Versus Perilesional 5% Dextrose Injection in Partial Rotator Cuff Tears
Partial Rotator Cuff Tears, Rotator Cuff Tendinopathy
Not yet recruiting
Effects of Percutaneous Electrical Stimulation in Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Arias Buría, PT, MSc principal investigator
Hospital Universitario Gregorio Marañón-Universidad Rey Juan Carlos
César Fernández de las Peñas, PT, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrolysis Percutaneous Therapeutic (EPTE) and Eccentric exercise in people with Supraspinatus Tendinopathy, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain intensity before and after the intervention (time frame: Baseline, after 2 weeks of treatment and one week after the last session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.