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

NCT07495254 | Not Yet Recruiting

• 1 other identifier: SIS_2025
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Epicondylitis (Tennis Elbow); Lateral Epicondylalgia; Lateral Elbow Tendinopathy

Keywords

Lateral Epicondylitis; Super Inductive System; high-intensity electromagnetic stimulation; exercises; pain; functionality

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 4 weeks (end of treatment), 3 months, and 6 months after end of treatment. Unit of Measure: Units on a 10 cm scale.

Secondary Outcomes (6)

• Pressure Pain Threshold measured by algometry

  Baseline, 4 weeks, 3 months, and 6 months after end of treatment. Unit of Measure: kg/cm²

• Elbow range of motion measured with a goniometer

  Baseline, 4 weeks, 3 months, and 6 months after end of treatment. Unit of Measure: Degrees (°).

• Grip strength measured with JAMAR dynamometer

  Baseline, 4 weeks, 3 months, and 6 months after end of treatment. Unit of Measure: Kilograms (kg).

• Upper limb disability measured with the QuickDASH score

  Baseline, 4 weeks, 3 months, and 6 months after end of treatment. Unit of Measure: Score (0-100)

• Health related quality of life measured with the EQ 5D 5L

  Baseline, 4 weeks, 3 months, and 6 months after end of treatment. Unit of Measure: Index score; VAS score (0-100)

Study Arms (2)

Therapeutic-dose Super Inductive System (SIS) + Therapeutic Exercise + Health Education

EXPERIMENTAL

Participants in this arm will receive therapeutic-dose Super Inductive System (SIS) treatment using the BTL-6000 Super Inductive System Elite, combined with a standardized therapeutic exercise program and a brief health education component. Treatment is provided twice per week for a total of eight sessions. Assessments will be performed at baseline, at the end of treatment, and at 3- and 6-month follow-ups.

Device: Super Inductive System (SIS), therapeutic dose; Behavioral: Therapeutic Exercise Program; Behavioral: Health Education

Non-therapeutic SIS (Active Placebo) + Therapeutic Exercise + Health Education

ACTIVE COMPARATOR

Participants in this arm will receive a non-therapeutic SIS protocol (active placebo: 10 minutes at 1 Hz, 59-second pause, 1% intensity) delivered with the BTL-6000 Super Inductive System Elite, together with the same standardized therapeutic exercise program and health education as the intervention arm. Treatment is provided twice per week for a total of eight sessions. Assessments will be performed at baseline, at the end of treatment, and at 3- and 6-month follow-ups.

Device: Super Inductive System (SIS), non-therapeutic dose (active placebo); Behavioral: Therapeutic Exercise Program; Behavioral: Health Education

Interventions

Super Inductive System (SIS), therapeutic dose DEVICE

Therapeutic-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

Therapeutic-dose Super Inductive System (SIS) + Therapeutic Exercise + Health Education

Therapeutic Exercise Program BEHAVIORAL

Standardized 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.

Non-therapeutic SIS (Active Placebo) + Therapeutic Exercise + Health Education; Therapeutic-dose Super Inductive System (SIS) + Therapeutic Exercise + Health Education

Health Education BEHAVIORAL

Brief education session including information about lateral elbow tendinopathy, ergonomic recommendations, preventive strategies, and guidance for daily activities.

Non-therapeutic SIS (Active Placebo) + Therapeutic Exercise + Health Education; Therapeutic-dose Super Inductive System (SIS) + Therapeutic Exercise + Health Education

Super Inductive System (SIS), non-therapeutic dose (active placebo) DEVICE

Non-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.

Non-therapeutic SIS (Active Placebo) + Therapeutic Exercise + Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Institut Català de la Salut: collaborator

Study Sites (1)

Anna Escribà Salvans

Mataró, Barcelona, 08303, Spain

Location

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Related Links

• Super Inductive System (SIS): High-power magnetotherapy
• Super Inductive System (SIS): High-power magnetotherapy
• Treatment protocol for lateral epicondylalgia of the elbow

MeSH Terms

Conditions

Tennis Elbow; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Escribà Salvans

  Universitat de Vic, Universitat Central de Catalunya (UVIC-UCC)

  STUDY DIRECTOR

Central Study Contacts

Anna Escribà Salvans, Degree in Physical Therapy

CONTACT

+34616384685; anna.escriba1@uvic.cat

Maria del Carmen Sánchez Mato

CONTACT

+34667617354; mariadelcarmen.sanchez@uvic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, the principal investigator, and the outcomes assessors are blinded to group allocation. Randomization is managed through opaque sequentially numbered envelopes. Only the physical therapists delivering the interventions have access to the randomization sequence.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: Randomized, triple-blind, multicenter, parallel-group clinical trial conducted in three Rehabilitation and Physical Therapy Services.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 27, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available starting in January 2027 and will remain available with no planned end date.
• Access Criteria: Access to IPD and supporting documentation will be granted to qualified researchers who request the data for legitimate scientific purposes and submit a proposal with a sound methodological approach and ethical rationale. Data will be provided in a fully de-identified format, along with relevant supporting documents when appropriate, and will be shared through secure transfer procedures to ensure participant confidentiality. Requests should be submitted to the Principal Investigator and will be evaluated on a case-by-case basis in accordance with applicable ethical and legal regulations. Data use will not be permitted for any purpose that could compromise participant privacy or well-being.

Locations

ES (1)