RecruitingNot Applicable

PEMF Therapy in Shoulder Tendinopathy

Romania60 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pr…

What they're measuring

Pain intensity assessed by Visual Analog Scale (VAS)

Timeframe: Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.

Trial details

NCT IDNCT07550543

SponsorBalnear and Rehabilitation Sanatorium Techirghiol

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Alexandra E Ciota, PhD Student

+40723662300 alexandra.ciota@365.univ-ovidius.ro