An interventional study of Ultrasound-Guided Percutaneous Electrolysis and Progressive Exercise-Based Rehabilitation in Supraspinatus Tendinopathy and Rotator Cuff Tendinopathy, sponsored by DAVID CRUZ DÍAZ. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by DAVID CRUZ DÍAZ · Not applicable, Interventional, and Treatment
Chronic supraspinatus tendinopathy is a common shoulder condition associated with persistent pain, reduced mobility, and limitations in daily activities. Exercise therapy is considered a first-line treatment; however, some patients continue to experience pain and functional limitations despite rehabilitation.
Percutaneous electrolysis is a minimally invasive physiotherapy technique that involves applying a low-intensity electrical current through a thin needle inserted into the affected tendon under ultrasound guidance. This treatment may help reduce pain and improve shoulder function when combined with therapeutic exercise.
The purpose of this randomized controlled trial is to investigate whether adding ultrasound-guided percutaneous electrolysis to a structured exercise rehabilitation program provides greater improvements in shoulder pain and disability than exercise therapy alone in adults with chronic supraspinatus tendinopathy.
Participants will be randomly assigned to one of two groups. Both groups will complete a six-week exercise program involving progressive shoulder strengthening, eccentric exercises, and scapular stabilization. Participants in the experimental group will additionally receive one session of ultrasound-guided percutaneous electrolysis per week for six weeks.
Shoulder pain and disability will be evaluated before and after the intervention using the Shoulder Pain and Disability Index (SPADI). Additional assessments will include pain intensity, shoulder range of motion, pain-related self-efficacy, and adverse events.
The investigators hypothesize that combining ultrasound-guided percutaneous electrolysis with exercise therapy will produce greater improvements in shoulder pain, disability, and functional outcomes compared with exercise therapy alone.
**Background and Rationale**
Chronic supraspinatus tendinopathy is a frequent cause of rotator cuff-related shoulder pain and is associated with impaired shoulder function, reduced tolerance to mechanical loading, and limitations in daily activities. Progressive exercise-based rehabilitation is widely recommended as a first-line conservative treatment. However, clinical outcomes remain heterogeneous, and additional therapeutic strategies may be beneficial for patients with persistent symptoms.
Ultrasound-guided percutaneous electrolysis (EPI) is an invasive physiotherapy technique involving the application of a low-intensity galvanic current through a solid filiform needle inserted into the affected tendon under ultrasound guidance. Experimental evidence suggests that galvanic stimulation may activate biological pathways associated with tendon remodeling and collagen production, although the clinical relevance of these mechanisms remains uncertain.
Previous randomized controlled trials have reported favorable outcomes following percutaneous electrolysis in individuals with supraspinatus tendinopathy. However, the additional clinical benefit of combining this intervention with a standardized progressive exercise program has not been fully established.
**Study Objectives**
The primary objective of this study is to determine whether adding ultrasound-guided percutaneous electrolysis to a standardized exercise rehabilitation program results in greater improvements in shoulder pain and disability compared with exercise therapy alone in individuals with chronic supraspinatus tendinopathy.
Secondary objectives include evaluating changes in pain intensity, pain-related self-efficacy, and active pain-free shoulder range of motion, as well as monitoring intervention-related adverse events.
**Study Design**
This study is designed as a prospective, two-arm, parallel-group randomized controlled trial with blinded outcome assessment.
Participants will be randomly allocated in a 1:1 ratio to either an experimental group receiving ultrasound-guided percutaneous electrolysis combined with exercise therapy or a control group receiving exercise therapy alone.
Randomization will be performed using a computer-generated allocation sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher.
Outcome assessors and data analysts will remain blinded to group allocation. Blinding of participants and treating physiotherapists will not be feasible because of the nature of the interventions.
**Intervention Protocol**
Both groups will participate in a standardized six-week exercise-based rehabilitation program consisting of progressive rotator cuff strengthening, eccentric loading of the supraspinatus tendon, and scapular stabilization exercises.
The rehabilitation program will include one supervised physiotherapy session per week and daily home exercises. Exercise intensity and progression will be individualized according to participants' symptoms, perceived exertion, and tolerance to mechanical loading.
Participants assigned to the experimental group will additionally receive ultrasound-guided percutaneous electrolysis once weekly for six consecutive weeks.
The electrolysis procedure will be performed under real-time ultrasound guidance to identify the affected region of the supraspinatus tendon and ensure accurate needle placement. A sterile filiform needle will be inserted into the target tendon region, followed by the application of a low-intensity galvanic current.
The electrolysis protocol will consist of a continuous galvanic current of 350 microamperes applied for 72 seconds during each treatment session.
Both groups will receive the same exercise rehabilitation program to isolate the additional clinical effects of percutaneous electrolysis.
**Outcome Assessment**
Clinical assessments will be conducted at baseline and six weeks after the beginning of the intervention.
The primary outcome will be the change in shoulder pain and disability measured using the Shoulder Pain and Disability Index (SPADI).
Secondary outcomes will include pain intensity at rest, during shoulder movement, and at night; pain-related self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ); and active pain-free shoulder range of motion measured using standardized goniometric procedures.
Adverse events potentially associated with the interventions, including post-needling soreness, minor bleeding, bruising, vasovagal reactions, and symptom exacerbation, will be monitored throughout the intervention period.
Treatment adherence will be assessed using exercise diaries, supervision records, and attendance at scheduled treatment sessions.
**Expected Contribution**
This study aims to provide additional evidence regarding the clinical effectiveness of ultrasound-guided percutaneous electrolysis as an adjunct to exercise-based rehabilitation in individuals with chronic supraspinatus tendinopathy.
The findings may help clarify whether combining a tendon-directed intervention with progressive therapeutic loading provides additional short-term clinical benefits compared with exercise therapy alone.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
This study's planned enrollment of 58 is above the median of 48 across 332 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →DAVID CRUZ DÍAZ is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive ultrasound-guided percutaneous electrolysis combined with a standardized exercise-based rehabilitation program over six weeks. Both interventions will be delivered concurrently throughout the treatment period.
Procedure: Ultrasound-Guided Percutaneous Electrolysis
Participants in this group will receive the same standardized six-week exercise-based rehabilitation program as the experimental group, without the addition of percutaneous electrolysis.
Behavioral: Progressive Exercise-Based Rehabilitation
Ultrasound-guided percutaneous electrolysis will be administered once weekly for six consecutive weeks by an experienced physiotherapist. Following skin disinfection with chlorhexidine, a sterile filiform needle (0.30 × 40 mm) will be inserted into the affected region of the supraspinatus tendon under real-time B-mode ultrasound guidance using a high-frequency linear transducer. A continuous galvanic current of 350 microamperes (µA) will be applied for 72 seconds, corresponding to an electrical charge of approximately 25.2 millicoulombs per session. A single application will be performed during each treatment session, targeting the tendon region showing the greatest ultrasonographic alterations. No local anesthetic will be administered. Participants will receive six electrolysis sessions in addition to the standardized exercise rehabilitation program.
Also known as: EPI
Participants will complete a standardized six-week exercise-based rehabilitation program comprising progressive rotator cuff strengthening, eccentric loading of the supraspinatus tendon, and scapular stabilization and motor control exercises. The program will include one supervised physiotherapy session per week and daily home exercises. Rotator cuff strengthening will involve isometric and isotonic exercises performed in the scapular plane. Eccentric supraspinatus exercises will emphasize a controlled lowering phase lasting 3-4 seconds. Scapular exercises will target the serratus anterior and lower trapezius muscles. Exercises will be prescribed as three sets of ten repetitions. Load progression will be individualized according to symptom tolerance, allowing pain of no more than 3/10 during exercise and no symptom exacerbation within the following 24 hours. The same exercise protocol will be administered to both treatment groups.
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Total Score at 6 Weeks
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index (SPADI), a validated 13-item self-reported questionnaire comprising pain (5 items) and disability (8 items) subscales. The total score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability. The primary outcome will be the change in the SPADI total score from baseline to week 6, calculated as the week 6 score minus the baseline score. Negative changes indicate improvement.
Time frame: Baseline and 6 weeks
Change From Baseline in Pain Intensity at Rest at 6 Weeks
Pain intensity at rest will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will report their average pain intensity at rest. Changes will be calculated as the week 6 score minus the baseline score, with negative values indicating pain reduction.
Time frame: Baseline and 6 weeks
Change From Baseline in Pain Intensity During Shoulder Movement at 6 Weeks
Pain intensity during shoulder movement will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will report their average pain intensity during shoulder movement. Changes will be calculated as the week 6 score minus the baseline score, with negative values indicating pain reduction.
Time frame: Baseline and 6 weeks
Change From Baseline in Night Pain Intensity at 6 Weeks
Night pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will report their average shoulder pain intensity experienced at night. Changes will be calculated as the week 6 score minus the baseline score, with negative values indicating pain reduction.
Time frame: Baseline and 6 weeks
Change From Baseline in Pain Self-Efficacy Questionnaire (PSEQ) Total Score at 6 Weeks
Pain-related self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire (PSEQ), a validated 10-item self-report instrument assessing confidence in performing daily activities despite pain. Total scores range from 0 to 60, with higher scores indicating greater pain self-efficacy. Changes will be calculated as the week 6 score minus the baseline score, with positive values indicating improvement.
Time frame: Baseline and 6 weeks
Change From Baseline in Active Pain-Free Shoulder Range of Motion at 6 Weeks
Active pain-free shoulder range of motion (ROM) will be assessed using a universal goniometer in four movement planes: flexion, abduction, external rotation, and internal rotation. Each movement will be measured in degrees following standardized procedures. Two consecutive measurements will be performed for each movement, and their mean will be recorded for analysis. Changes will be calculated as the week 6 measurement minus the baseline measurement, with positive values indicating improved mobility. Each movement will be analyzed separately.
Time frame: Baseline and 6 weeks
Percentage of Participants Achieving a Clinically Important Improvement in SPADI at 6 Weeks
The proportion of participants achieving a clinically important improvement in shoulder pain and disability will be calculated using the change in the Shoulder Pain and Disability Index (SPADI) total score from baseline to week 6. A clinically important improvement will be defined using a prespecified threshold established in the study protocol.
Time frame: Baseline and 6 weeks
Exercise Program Adherence
Adherence to the prescribed exercise program will be assessed using participant training diaries and weekly supervision records. Adherence will be calculated as the percentage of completed exercise sessions relative to the total number of prescribed sessions during the six-week intervention period.
Time frame: Throughout the 6-week intervention period
Percutaneous Electrolysis Treatment Adherence
Adherence to percutaneous electrolysis will be assessed in the experimental group by recording attendance at the six scheduled treatment sessions. Adherence will be expressed as the percentage of completed electrolysis sessions relative to the six prescribed sessions.
Time frame: Throughout the 6-week intervention period
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in scientific publications may be made available to qualified researchers upon reasonable request to the principal investigator. Data sharing will be considered on a case-by-case basis, subject to the scientific merit of the request, approval by the principal investigator, applicable ethical requirements, participant consent, and data protection regulations. Requests must include a research proposal describing the intended use of the data. Data will only be shared following approval of the request and, where appropriate, the establishment of a data-sharing agreement to ensure confidentiality and responsible data use.
Supporting information: Study protocol
Time frame: De-identified individual participant data and supporting information will be available upon reasonable request beginning 6 months after publication of the primary study results and for a period of 5 years thereafter.
Access criteria: De-identified individual participant data (IPD) and the study protocol may be made available to qualified researchers upon reasonable request to the principal investigator. Requests must include a scientifically justified research proposal specifying the study objectives, methodology, and intended use of the data. Each request will be evaluated on a case-by-case basis by the principal investigator. Access will be granted only for legitimate scientific purposes, subject to compliance with applicable ethical requirements, participant consent, and data protection regulations. Approved applicants may be required to sign a data-sharing agreement ensuring confidentiality, data security, and use of the information exclusively for the approved research purposes.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
DAVID CRUZ DÍAZ