Evaluation of the Effectiveness of Capacitive and Resistive Energy Transfer Therapy for Lateral Epicondylitis
Effectiveness of Capacitive and Resistive Energy Transfer Therapy in Patients With Lateral Epicondylitis: A Sham-Controlled, Double-Blind Randomized Clinical Trial
1 other identifier
interventional
62
1 country
1
Brief Summary
This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of Capacitive and Resistive Energy Transfer (TECAR) therapy in patients with lateral epicondylitis. Participants will be randomly assigned to either a TECAR plus exercise group or a sham TECAR plus exercise group. Both groups will receive a standardized home exercise program including elbow and wrist range-of-motion, stretching, eccentric strengthening, and handgrip strengthening exercises. The TECAR group will additionally receive active TECAR therapy, while the control group will receive sham TECAR treatment using the same device and treatment protocol without therapeutic energy delivery. Outcome assessments will be performed by a blinded evaluator at baseline, immediately after treatment, and at 1- and 2-month follow-up visits. The study aims to determine whether TECAR therapy provides additional benefits in pain relief, functional improvement, and clinical outcomes when combined with exercise therapy in patients with lateral epicondylitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2026
CompletedFirst Submitted
Initial submission to the registry
June 3, 2026
CompletedFirst Posted
Study publicly available on registry
June 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 11, 2027
June 11, 2026
June 1, 2026
7 months
June 3, 2026
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is the most commonly used outcome measure for assessing pain intensity in studies involving lateral epicondylitis. It typically consists of a 10-cm horizontal line anchored by the descriptors "no pain" and "worst imaginable pain" at each end. Participants are asked to mark the point on the line that best represents their perceived pain intensity, and the distance from the left endpoint to the marked point is recorded in centimeters. In the present study, the VAS will be used to assess pain experienced in the elbow region during activity.
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Secondary Outcomes (5)
Pressure Pain Threshold Measurement with Algometry
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Ultrasonographic evaluation
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Handgrip Strength
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Quick Disabilities Of The Arm, Shoulder And Hand (Quick-DASH)
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Study Arms (2)
TECAR Therapy + Exercise
EXPERIMENTALParticipants will receive active TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
Sham TECAR Therapy + Exercise
SHAM COMPARATORParticipants will receive sham TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
Interventions
Participants assigned to this group will receive active Capacitive and Resistive Electrical Transfer (TECAR) therapy in addition to a standard home exercise program. Active TECAR therapy will be administered five times a week for two weeks (10 sessions in total), with each session lasting 15 minutes.
Participants assigned to this group will receive sham TECAR therapy in addition to the same standardized home exercise program. The sham intervention will be delivered using the same device, applicator, treatment duration, and application procedures as the active treatment; However, no therapeutic energy will be delivered.
Eligibility Criteria
You may qualify if:
- Patients with lateral epicondylitis who have experienced elbow pain for at least 6 weeks and have at least two positive provocative tests (Cozen's, Mill's, or Maudsley's test).
- Age between 18 and 65 years.
- Unilateral pain and tenderness over the lateral epicondyle lasting longer than 6 weeks.
- Clinically diagnosed lateral epicondylitis.
- No cognitive impairment.
- Willingness to participate and provide informed consent.
You may not qualify if:
- History of interventional injection to the affected elbow within the previous 3 months.
- Receipt of physical therapy for the affected elbow within the previous 3 months.
- Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) within the previous 2 weeks.
- History of fracture or surgery involving the affected elbow.
- Presence of a chronic inflammatory disease.
- History of malignancy.
- Active infection.
- Pregnancy.
- Presence of a cardiac pacemaker or other electronic implant.
- Coagulation disorders.
- Cervical radiculopathy, entrapment neuropathy, or peripheral nerve injury.
- Body mass index (BMI) ≥ 35 kg/m².
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziantep City Hospital
Gaziantep, Gaziantep, 06170, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- This study employs a double-blind design in which both participants and outcome assessors are blinded to treatment allocation. Participants will receive either active TECAR therapy or sham TECAR therapy using the same device, applicator, treatment duration, and treatment procedures. The sham intervention will mimic the active treatment without delivering therapeutic energy. Outcome assessments will be performed by an independent evaluator who will remain unaware of group allocation throughout the study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
June 3, 2026
First Posted
June 8, 2026
Study Start
May 11, 2026
Primary Completion (Estimated)
December 11, 2026
Study Completion (Estimated)
May 11, 2027
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
- Time Frame
- Data will be available after publication of the study results.
- Access Criteria
- De-identified individual participant data and supporting documents will be available to qualified researchers upon reasonable request to the principal investigator. Access will be granted for scientific research purposes after approval of the research proposal. Data will be shared through secure electronic transfer.
The individual participant data (IPD) generated and analyzed during the current study will not be publicly shared. However, de-identified data may be made available by the corresponding author upon reasonable request, subject to ethical approval and institutional data-sharing policies.