| NCT ID | NCT07550543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Balnear and Rehabilitation Sanatorium Techirghiol |
| Condition | Shoulder Tendinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-04-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate whether pulsed electromagnetic field (PEMF) therapy delivered via the Super Inductive System (SIS), integrated into a multimodal rehabilitation program, improves pain, function, pressure pain threshold, muscle strength, psychological status, and quality of life in adults with shoulder tendinopathies. The main questions it aims to answer are: * Does the addition of PEMF (SIS) therapy reduce pain intensity and improve pressure pain threshold compared to standard balneophysiotherapy? * Does PEMF (SIS) therapy improve shoulder function, muscle strength, psychological status, and quality of life? The study will compare a multimodal rehabilitation program supplemented with PEMF (SIS) therapy to standard balneophysiotherapy to determine whether the addition of PEMF (SIS) provides superior clinical outcomes. Participants will: * Undergo a multimodal rehabilitation program including balneophysiotherapy * Be assigned to receive either standard treatment or treatment supplemented with PEMF (SIS) therapy * Be evaluated at baseline (admission), immediately after treatment completion (discharge), and at 4 weeks after treatment using validated clinical instruments assessing pain, function, pressure pain threshold, muscle strength, psychological status, depressive symptoms, and quality of life.
Eligibility Criteria
Inclusion Criteria: * Adults aged between 18 and 70 years. * Patients with chronic shoulder pain lasting more than 3 months, of non-traumatic origin, persistent despite prior conservative treatment. * Clinical diagnosis of shoulder tendinopathy and/or subacromial pain syndrome based on medical history and physical examination. * Presence of shoulder pain and functional limitation confirmed by clinical assessment and baseline functional evaluation (SPADI). * Ability to comply with the treatment protocol and attend scheduled follow-up assessments. * Provision of written informed consent prior to participation. Exclusion Criteria: * Full-thickness rotator cuff tears with surgical indication. * Recent major shoulder trauma (within the last 6 months). * Active systemic inflammatory or rheumatologic diseases. * Presence of metallic implants in the treatment area or implanted electronic devices (e.g., pacemaker). * Neurological disorders affecting the upper limb. * Contraindications to balneotherapy (e.g., severe cardiovascular disease, renal failure, severe dermatological conditions). * Decompensated chronic diseases at the time of enrollment (cardiovascular, hepatic, renal, respiratory, or neurological). * Skin lesions at the site of treatment application. * Pregnancy or breastfeeding. * Active neoplastic disease. * Decompensated psychiatric disorders. * History of hypersensitivity to natural therapeutic factors used in balneotherapy. * Refusal to participate or inability to provide informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07550543 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Shoulder Tendinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07550543 currently recruiting?
Yes, NCT07550543 is actively recruiting participants. Contact the research team at alexandra.ciota@365.univ-ovidius.ro for enrollment information.
Where is the NCT07550543 trial being conducted?
This trial is being conducted at Constanța, Romania.
Who is sponsoring the NCT07550543 clinical trial?
NCT07550543 is sponsored by Balnear and Rehabilitation Sanatorium Techirghiol. The trial plans to enroll 60 participants.