By invitationNCT07929675ClinicalTrials.gov record

Ultrasound-Guided Percutaneous Electrolysis Plus Exercise for Chronic Supraspinatus Tendinopathy

Supraspinatus Tendinopathy · Rotator Cuff Tendinopathy

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - 70 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 58 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

\*\*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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Adults aged between 18 and 70 years.
Chronic shoulder pain lasting at least 3 months.
Clinical diagnosis of supraspinatus tendinopathy, supported by at least one positive clinical test (Jobe test, Hawkins-Kennedy test, or Neer test).
Ultrasonographic findings consistent with supraspinatus tendinopathy, including tendon hypoechogenicity, tendon thickening, or neovascularization.
Shoulder Pain and Disability Index (SPADI) total score of at least 20 out of 100.
Average shoulder pain intensity of at least 4 out of 10 on the Numerical Rating Scale (NRS) during the preceding week.
Provision of written informed consent before enrollment.

Exclusion Criteria:

Full-thickness rotator cuff tear.
Previous surgical intervention involving the affected shoulder.
Corticosteroid injection in the affected shoulder within the preceding 3 months.
Neurological disorders affecting shoulder function.
Rheumatological diseases affecting shoulder function.
Systemic disorders that may interfere with shoulder function or rehabilitation.
Pregnancy.
Contraindications to percutaneous electrolysis, including anticoagulant therapy, coagulation disorders, or local skin infection.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Double masked

Percutaneous Electrolysis Plus Exercise

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

Exercise Therapy Alone

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 PROCEDURE

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.

Progressive Exercise-Based Rehabilitation BEHAVIORAL

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.

Prepare your questions