PEMF Therapy in Shoulder Tendinopathy
ConditionShoulder Tendinopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBalnear and Rehabilitation Sanatorium Techirghiol
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Nanopulsed Electromagnetic Field Therapy (SIS)
DeviceNanopulsed electromagnetic field therapy is delivered using the Super Inductive System (SIS) device applied to the affected shoulder. The intervention is administered daily over a two-week period, with a total of 10 sessions. Each session lasts approximately 10-15 minutes. The therapy delivers high-intensity electromagnetic pulses with adjustable frequency and intensity, aiming to reduce pain, stimulate tissue regeneration, and improve functional outcomes.
Balneophysiotherapy
Other interventionThe intervention is based on the region's specific natural therapeutic resources and is conducted under continuous medical supervision. The treatment program includes saline therapeutic baths combined with exercise therapy and applications of sapropelic therapeutic mud, administered daily over a two-week period, five days per week. In addition, patients receive electrotherapy according to a standardized protocol, including magnetotherapy, interferential current therapy, and therapeutic ultrasound. The rehabilitation program also incorporates massage therapy and individualized therapeutic exercises.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Balneophysiotherapy plus Nanopulsed Electromagnetic Field Therapy GroupExperimental treatment 1 intervention
Group B: Balneophysiotherapy Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity assessed by Visual Analog Scale (VAS)
Pain intensity will be measured using the Visual Analog Scale (VAS). Participants were asked to rate their current pain intensity by marking a point on a 100-mm horizontal line, where 0 indicates "no pain" and 100 indicates "worst pain imaginable." The score was recorded in millimeters (mm). Outcome range and interpretation: Minimum value: 0; Maximum value: 100. Higher scores indicate worse pain intensity.
Time frame
Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.Secondary outcomes
1
Shoulder function assessed by Shoulder Pain and Disability Index (SPADI)
Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI), a self-administered questionnaire consisting of two domains: pain (5 items) and disability (8 items). Each item is scored on a scale from 0 to 10, with higher scores indicating greater pain and functional impairment. The total SPADI score is expressed as a percentage (0-100%).
Time frame
Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.2
Pressure Pain Threshold (PPT) assessed by digital algometry
Pressure pain threshold will be measured using a digital algometer at standardized anatomical points of the shoulder. The mean value of repeated measurements will be recorded.
Time frame
Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.3
Range of motion (ROM) assessed by goniometry
Active range of motion of the shoulder (flexion, abduction, external rotation, internal rotation) will be measured using a goniometer.
Time frame
Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.4
Muscle strength assessed by dynamometry
Shoulder muscle strength was assessed using a handheld dynamometer. Measurements were performed for key shoulder movements, and values were recorded in kilograms. Higher values indicate greater muscle strength.
Time frame
Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.Sponsors and contacts
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Source ClinicalTrials.gov