PEMF Therapy in Shoulder Tendinopathy (NCT07550543) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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