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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Lateral Epicondylitis (Tennis Elbow), Lateral Epicondylalgia, Lateral Elbow Tendinopathy

In brief

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.

Key facts

Study ID: NCT07495254
Run by: University of Vic - Central University of Catalonia
People needed: 224
Starts: 2026-03-30
Expected to finish: 2028-09-01
Last updated by the study team: 2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults aged 18 years or older.
Clinical diagnosis of lateral elbow tendinopathy confirmed by a Family Care Physician, Rehabilitation Physiatrist, Orthopedic Surgeon, or Rheumatologist.
Referral to one of the three participating Rehabilitation and Physical Therapy Services (Mataró, Sant Andreu, or Drassanes).
Presence of at least one positive provocative test (Cozen's test or Mill's test).
Ability and willingness to participate in the study after reading the patient information sheet and signing the informed consent, including consent for image use.

You may not qualify if…

Medial elbow tendinopathy.
Recent traumatic injury to the affected upper limb within the past 6 months.
Passive elbow joint range of motion limited by more than 20°.
Injection in the affected elbow within 6 weeks prior to baseline assessment.
Systemic inflammatory, autoimmune, infectious, or neoplastic disease.
Pregnancy.
Metal implants in the affected elbow region.
Pacemaker or implantable defibrillator.
Radial tunnel syndrome / Frohse arcade syndrome.
Coagulation disorders.
Cognitive or sensory impairment that precludes participation in the study procedures.
Central sensitization syndromes (e.g., fibromyalgia, chronic fatigue syndrome).

Where it is running

Anna Escribà Salvans — Mataró, Barcelona, Spain

Full record on ClinicalTrials.gov

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