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.
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).
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.
Parallel
Super Inductive System (SIS), therapeutic dose
DeviceTherapeutic-dose Super Inductive System (SIS) delivered with the BTL-6000 Super Inductive System Elite for 10 minutes using the protocol for elbow tendinopathy. Intensity is adjusted to the participant's tolerated motor threshold
Super Inductive System (SIS), non-therapeutic dose (active placebo)
DeviceNon-therapeutic SIS protocol delivered for 10 minutes at 1 Hz with a 59-second pause and 1% intensity using the BTL-6000 Super Inductive System Elite. Used as an active placebo.
Therapeutic Exercise Program
BehavioralStandardized upper-extremity therapeutic exercise program with weekly progression based on mobility, strength, and pain. Exercises are performed four days per week, two sets of ten repetitions per exercise, and include self-massage of the affected musculature.
Health Education
BehavioralBrief education session including information about lateral elbow tendinopathy, ergonomic recommendations, preventive strategies, and guidance for daily activities.
Change in pain intensity measured with the 10-cm Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10 cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants mark their perceived pain intensity on the line, and the score is recorded in centimeters.
Pressure Pain Threshold measured by algometry
Pressure Pain Threshold (PPT) will be assessed using a handheld algometer. Progressive pressure is applied perpendicular to the skin over the affected lateral epicondyle until the participant indicates the first sensation of pain. Three measurements will be taken, and the mean value will be used for analysis.
Elbow range of motion measured with a goniometer
Elbow joint mobility will be assessed using a standard universal goniometer, measuring active flexion, extension, pronation, and supination. Three measurements will be recorded for each movement, and the mean value will be used.
Grip strength measured with JAMAR dynamometer
Grip strength will be measured using a JAMAR hydraulic hand dynamometer. Participants will perform three maximal voluntary contractions with the affected hand, and the mean force output will be recorded.
Upper limb disability measured with the QuickDASH score
Upper limb function and disability will be evaluated using the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire. Total scores range from 0 (no disability) to 100 (severe disability).
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University of Vic - Central University of Catalonia
Lead sponsor
Institut Català de la Salut
Collaborator
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