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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain intensity assessed by Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 provide informed consent.
研究组 & 干预措施
Balneophysiotherapy plus Nanopulsed Electromagnetic Field Therapy Group
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.
干预措施: Nanopulsed Electromagnetic Field Therapy (SIS) (Device)
Balneophysiotherapy Control Group
Participants allocated to the control group receive a structured two-week rehabilitation program comprising balneophysiotherapy interventions at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania.
干预措施: Balneophysiotherapy (Other)
结局指标
主要结局
Pain intensity assessed by Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Shoulder function assessed by Shoulder Pain and Disability Index (SPADI)(Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.)
- Pressure Pain Threshold (PPT) assessed by digital algometry(Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.)
- Range of motion (ROM) assessed by goniometry(Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.)
- Muscle strength assessed by dynamometry(Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.)
- Psychological status assessed by Hospital Anxiety and Depression Scale (HADS)(Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.)
- Depression severity assessed by Patient Health Questionnaire-9 (PHQ-9)(Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.)
- Quality of life assessed by EQ-5D-5L(Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.)
研究者
Elena-Valentina Ionescu
Professor (Associate) Dr. Ionescu Elena-Valentina
Balnear and Rehabilitation Sanatorium Techirghiol