Evaluation of the Effectiveness of Capacitive and Resistive Energy Transfer Therapy for Lateral Epicondylitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGaziantep City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TECAR Therapy + Exercise
DeviceParticipants 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.
Sham TECAR Therapy + Exercise
DeviceParticipants 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: TECAR Therapy + ExerciseExperimental treatment 1 intervention
Group B: Sham TECAR Therapy + ExerciseSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).Secondary outcomes
1
Pressure Pain Threshold Measurement with Algometry
An algometer is a device used to assess pain sensitivity by measuring the Pressure Pain Threshold (PPT), defined as the minimum pressure required to be perceived as painful. Using a 1 cm² probe, pressure is applied perpendicular to the skin at a rate of 1 kg/s. Participants are instructed to indicate when the sensation changes from pressure to pain. PPT measurement provides a quantitative assessment of pain sensitivity and is widely used in clinical practice.
Time frame
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).2
Ultrasonographic evaluation
Ultrasonographic assessments will be performed by an experienced physiatrist blinded to treatment allocation. Participants will be examined in a seated position with the elbow flexed to approximately 90°, the forearm pronated, and the arm supported. Imaging will be conducted using a 7-12 MHz linear transducer, with the common extensor tendon (CET) aligned along its longitudinal axis. CET thickness will be measured at a standardized point located approximately 10 mm distal to its attachment on the lateral epicondyle. In addition to tendon thickness, tendon heterogeneity, focal hypoechoic areas, calcifications, tears, and enthesitis will be evaluated and recorded.
Time frame
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).3
Handgrip Strength
Handgrip strength will be measured in kilograms using a hand dynamometer. During the assessment, participants will be seated with the shoulder adducted and in neutral rotation, the elbow flexed to 90°, and the forearm and wrist in a neutral position, with the elbow supported. Participants will be instructed to squeeze the dynamometer up to their pain threshold. Three measurements will be obtained, and the mean value will be recorded.
Time frame
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).4
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to assess pain and functional disability in patients with lateral epicondylitis. It consists of three subscales: pain (5 items), usual activities (4 items), and specific activities (6 items). Each item is scored on a scale from 0 to 10, with higher scores indicating greater pain or difficulty. The pain subscale ranges from 0 to 50, while the functional subscale ranges from 0 to 50. The total PRTEE score is calculated by summing the pain and functional scores, yielding a total score between 0 and 100, with higher scores indicating greater pain and functional impairment.
Time frame
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).Sponsors and contacts
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Source ClinicalTrials.gov