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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:
Participants will:
Shoulder tendinopathies are a common cause of pain, functional limitation, and reduced quality of life, with a significant impact on daily activities. Their clinical presentation is heterogeneous, involving not only structural and functional impairments but also activity limitations and participation restrictions.
Conservative management remains the first-line approach and typically includes multimodal rehabilitation programs incorporating balneophysiotherapy, exercise therapy, and physical modalities. Although these interventions are widely used and have demonstrated clinical benefits, the optimal combination of therapeutic modalities remains a subject of ongoing research.
Pulsed electromagnetic field (PEMF) therapy delivered via the Super Inductive System (SIS) is a non-invasive intervention with potential analgesic, neuromodulatory, and regenerative effects. However, evidence regarding its additional benefit when integrated into standard multimodal rehabilitation programs for shoulder tendinopathies is still limited.
Given the multifactorial nature of shoulder tendinopathies, a multidimensional assessment approach is required. This study is based on the framework of the International Classification of Functioning, Disability and Health (ICF) and aligned with OMERACT recommendations, allowing a comprehensive evaluation of clinical outcomes across multiple domains.
The aim of this study is to compare the effectiveness of PEMF therapy delivered via SIS, integrated into a multimodal rehabilitation program, with standard balneophysiotherapy in patients with shoulder tendinopathies.
Participants are allocated to either a control group receiving standard treatment or an experimental group receiving the same rehabilitation program supplemented with PEMF (SIS) therapy. Clinical outcomes, including pain intensity, shoulder function, pressure pain threshold, muscle strength, psychological status, depressive symptoms, and quality of life, are assessed at baseline (admission), immediately after treatment completion (discharge), and at 4 weeks after treatment.
This study seeks to determine whether the addition of PEMF (SIS) therapy provides superior outcomes within a multimodal rehabilitation strategy and supports a personalized, multidimensional approach to the management of shoulder tendinopathies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balneophysiotherapy plus Nanopulsed Electromagnetic Field Therapy Group | Experimental | Participants in the experimental group receive a standardized balneophysiotherapy program combined with nanopulsed electromagnetic field therapy (Super Inductive System) applied to the affected shoulder, delivered over 10 treatment days at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania. |
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| Balneophysiotherapy Control Group | Active Comparator | Participants allocated to the control group receive a structured two-week rehabilitation program comprising balneophysiotherapy interventions at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanopulsed Electromagnetic Field Therapy (SIS) | Device | Nanopulsed 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, immediately after the 2-week treatment period, and at 1-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra E Ciota, PhD Student | Contact | +40723662300 | alexandra.ciota@365.univ-ovidius.ro |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balneal and Rehabilitation Sanatorium of Techirghiol | Recruiting | Constanța | Techirghiol | 906100 | Romania |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| Balneophysiotherapy | Other | The 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. |
|
| Baseline, immediately after the 2-week treatment period, and at 1-month follow-up. |
| 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. | Baseline, immediately after the 2-week treatment period, and at 1-month follow-up. |
| 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. | Baseline, immediately after the 2-week treatment period, and at 1-month follow-up. |
| 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. | Baseline, immediately after the 2-week treatment period, and at 1-month follow-up. |
| Psychological status assessed by Hospital Anxiety and Depression Scale (HADS) | Psychological status was assessed using the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D), each containing 7 items. Participants rated how they had been feeling over the previous week. Each item is scored on a 4-point Likert scale ranging from 0 to 3. Subscale scores were calculated by summing the relevant item scores and are reported as unitless values. Outcome range and interpretation: HADS-A (Anxiety): Minimum value: 0; Maximum value: 21. Higher scores indicate greater anxiety severity. HADS-D (Depression): Minimum value: 0; Maximum value: 21. Higher scores indicate greater depressive symptom severity. | Baseline, immediately after the 2-week treatment period, and at 1-month follow-up. |
| Depression severity assessed by Patient Health Questionnaire-9 (PHQ-9) | Depression severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a self-administered questionnaire consisting of 9 items scored from 0 to 3. Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms. | Baseline, immediately after the 2-week treatment period, and at 1-month follow-up. |
| Quality of life assessed by EQ-5D-5L | Quality of life was assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity. Higher scores indicate poorer quality of life. | Baseline, immediately after the 2-week treatment period, and at 1-month follow-up. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |