Balneal and Rehabilitation Sanatorium of Techirghiol
Constanța, Techirghiol, 906100, Romania
Location status: Recruiting
NCT Number: NCT07550543
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Constanța, Techirghiol, 906100, Romania
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.
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.
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.
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.
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.
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.
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.
Time frame: Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.
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.
Time frame: Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.
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.
Contact information is provided by the study sponsor or research team.
Balnear and Rehabilitation Sanatorium Techirghiol
Other
Effect of Pulsed Electromagnetic Field (PEMF) Therapy Delivered Via the Super Inductive System (SIS) Combined With Balneophysiotherapy in Patients With Shoulder Tendinopathies: A Randomized Controlled Trial
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