Clinical Research Directory

Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Exercise and Health Education in Lateral Elbow Tendinopathy

Sponsor: University of Vic - Central University of Catalonia

Summary

Background Lateral epicondylalgia is the most common cause of lateral elbow pain and affects approximately 1% to 3% of the population. It reduces strength, functionality, and quality of life, leading to limitations in work and daily activities and representing a relevant public health concern. Current scientific evidence suggests conservative physical therapy as the first-line treatment; however, heterogeneity exists among approaches, and clinical guidelines remain unclear. Rest and pharmacological treatment may provide short-term relief but do not resolve the underlying condition and may lead to recurrences. Therapeutic exercise has been shown to improve pain, strength, and function and is recommended as a first-line conservative intervention due to its favorable cost-benefit ratio. Thermotherapy and electrotherapy may also reduce pain and improve function compared with placebo. This study aims to evaluate the efficacy of the Super Inductive System (SIS) combined with a conventional physical therapy program. Hypothesis SIS therapy, combined with an upper extremity therapeutic exercise program and health education, will reduce pain, improve mobility and limb function, increase grip strength, facilitate return to activities of daily living (ADLs), and enhance perceived quality of life in individuals with lateral elbow tendinopathy. Objective To assess the effectiveness of SIS combined with therapeutic exercise and health education in adults aged 18 years and older with lateral elbow tendinopathy, compared with the application of SIS at a non therapeutic dose combined with conventional therapeutic exercise and health education. Methodology A prospective, experimental, randomized clinical trial will be conducted using a triple blind design (principal investigator, assessor, and participant). The study will include an intervention group (IG) (SIS at a therapeutic dose plus therapeutic exercise and health education) and a control group (CG) (SIS at a non therapeutic dose plus therapeutic exercise and health education). This multicenter study will take place at three Rehabilitation and Physical Therapy Services (Mataró, Sant Andreu-Barcelona, and Drassanes-Barcelona), all part of the Primary Care network of the Catalan Health Institute (ICS). Data collection will occur at baseline, post treatment, and at 3 and 6 month follow ups. Outcome measures will assess pain using the Visual Analog Scale (VAS) and algometry, mobility through goniometric evaluation, upper limb function using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), grip strength with dynamometry, health related quality of life with the EQ 5D 5L, and elbow specific pain and functional status using the Patient-Rated Tennis Elbow Evaluation (PRTEE). Inferential analyses will be performed for within group and between group comparisons. Data will be processed in accordance with current legislation. Data management will be performed using REDCap (Research Electronic Data Capture). Expected Outcomes A statistically significant improvement is expected in the intervention group compared with the control group. The use of SIS may contribute to reduced recovery time, fewer and shorter temporary work disabilities, and lower pharmaceutical costs among individuals with lateral epicondylalgia. Applicability and Relevance SIS is an innovative non invasive therapeutic technology that reduces acute and chronic pain, improves joint mobility, and promotes muscle strengthening in tendinopathies. Demonstrating its effectiveness and cost efficiency may support its incorporation into routine clinical practice, potentially reducing treatment duration, recovery time, and reliance on pharmacological therapy. This study will provide evidence to inform the implementation of SIS as an additional therapeutic tool in primary care physical therapy and rehabilitation settings.

Official title: Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Physical Therapy Exercise and Health Education in Lateral Elbow Tendinopathy

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