Comparison of Extracorporeal Shock Wave Therapy and Low-Level Laser Therapy in Patients With Lateral Epicondylitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHitit University

About this trial

Background:

Lateral epicondylitis is a common musculoskeletal condition characterized by pain and functional impairment of the elbow, often associated with degenerative changes in the common extensor tendon. Extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) are widely used noninvasive treatment modalities; however, comparative evidence regarding their clinical and structural effects remains limited.

Objective:

This study aims to compare the effects of ESWT and LLLT on pain intensity, elbow function, quality of life, grip strength, and ultrasonographic characteristics of the extensor tendon (thickness and echogenicity) in patients with lateral epicondylitis.

Methods:

This prospective, randomized, single-blind, comparative clinical trial will be conducted at the Physical Medicine and Rehabilitation outpatient clinic. Patients aged 18-65 years with clinically diagnosed lateral epicondylitis and symptom duration of at least six weeks will be included. All participants will receive a tennis elbow brace and a standardized exercise program. Participants will be randomly assigned to receive either ESWT or LLLT. ESWT will be applied to the lateral epicondyle region using a standardized protocol once weekly for 3 weeks. LLLT will be administered to the same region using standard clinical protocol three times per week for 3 weeks.

Assessments will be performed before and after treatment. Pain will be evaluated using the Visual Analog Scale (VAS), elbow function using the Patient-Rated Tennis Elbow Evaluation (PRTEE), quality of life using the Short Form-36 (SF-36), and grip strength using a hand dynamometer. Ultrasonographic evaluation of the common extensor tendon will be performed by a blinded specialist using a high-frequency linear probe to assess tendon thickness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of lateral epicondylitis based on physical examination findings

Symptom duration of at least 6 weeks

Presence of lateral elbow pain aggravated by wrist extension and/or gripping activities

Ability to understand and comply with study procedures

Disqualifiers

Previous surgery involving the affected elbow

History of corticosteroid or other injection therapy to the affected elbow within the last 6 months

Presence of inflammatory rheumatic diseases (e.g., rheumatoid arthritis)

Neurological disorders affecting the upper extremity

Trial design

Design model

Parallel

Treatments tested in this trial

  • ESWT Group

    Behavioral

    ESWT will be applied to the lateral epicondyle region using a standardized protocol for 3 sessions in three weeks

  • LLLT Group

    Behavioral

    LLLT will be applied to the lateral epicondyle region using a standardized protocol three times per week for 3 weeks

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: ESWT GroupExperimental treatment 1 intervention
Group B: LLLT GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity will be measured by the Visual Analog Scale (VAS)

Pain intensity will be measured by the Visual Analog Scale (VAS), a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to indicate their pain level, and the score will be recorded accordingly.

Time frame
Baseline and after 3 weeks of treatment

Secondary outcomes

1

Elbow function and pain-related disability will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.

Elbow function and pain-related disability will be assessed by Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. The PRTEE is a validated, patient-reported outcome measure consisting of 15 items evaluating pain and functional limitations. Scores range from 0 to 100, with higher scores indicating greater pain and disability.

Time frame
Baseline and after 3 weeks of treatment
2

Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire

Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire, a validated instrument consisting of 36 items that evaluate eight domains of health-related quality of life, including physical functioning, bodily pain, and mental health. Scores range from 0 to 100, with higher scores indicating better quality of life.

Time frame
Baseline and after 3 weeks of treatment
3

Grip strength will be measured using a Jamar hand dynamometer

Grip strength will be measured using a Jamar hand dynamometer in a standardized position. Measurements will be performed three times, and the average value will be recorded.

Time frame
Baseline and after 3 weeks of treatment
4

Ultrasonographic assessment of extensor tendon thickness

Extensor tendon thickness will be measured by an experienced physiatrist blinded to treatment allocation using ultrasonography. Measurements will be performed over the common extensor tendon at the level of the lateral epicondyle using a high-frequency linear probe.

Time frame
Baseline and after 3 weeks of treatment

Other outcomes

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