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

NCT07564713 | Not Yet Recruiting

• 1 other identifier: 2026-15
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lateral Epicondylitis (Tennis Elbow)

Keywords

Lateral epicondylitis; extracorporeal shock wave therapy; ultrasonography; low-intensity laser therapy; tennis elbow

Outcome Measures

Primary Outcomes (1)

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

  Pain intensity will be measured by the 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.

  Baseline and after 3 weeks of treatment

Secondary Outcomes (4)

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

  Baseline and after 3 weeks of treatment

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

  Baseline and after 3 weeks of treatment

• Grip strength will be measured using a Jamar hand dynamometer

  Baseline and after 3 weeks of treatment

• Ultrasonographic assessment of extensor tendon thickness

  Baseline and after 3 weeks of treatment

Study Arms (2)

ESWT Group

EXPERIMENTAL

Participants in the experimental group will receive a tennis elbow brace and a standardized exercise program, and additionally undergo extracorporeal shock wave therapy (ESWT). ESWT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol (1.6 bar, 2000 pulses, 10 Hz, once weekly for 3 weeks).

Behavioral: ESWT Group

LLLT Group

ACTIVE COMPARATOR

Participants in the active comparator group will receive a tennis elbow brace and a standardized exercise program, and additionally undergo low-level laser therapy (LLLT). LLLT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol three times per week for 3 weeks at four points, 40 seconds per point, with a dose of 4 J/cm².

Behavioral: LLLT Group

Interventions

ESWT Group BEHAVIORAL

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

ESWT Group

LLLT Group BEHAVIORAL

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

LLLT Group

Eligibility Criteria

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

You may qualify if:

• 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
• Provision of written informed consent

You may not qualify if:

• 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
• Systemic inflammatory or metabolic diseases that may affect tendon structure or healing
• Cervical radiculopathy or other causes of referred upper extremity pain
• Pregnancy or breastfeeding
• Use of anticoagulant therapy or bleeding disorders
• Severe comorbid conditions that may interfere with participation

Sponsors & Collaborators

• Hitit University: lead

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Pınar Başaran, Dr

  Hitit University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pınar Başaran, Dr

CONTACT

00903642230300; pinarozge@yahoo.com

Ayşe Doğan, Ass Prof

CONTACT

00903642230300; dr.mdagu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Participants will be randomly allocated in a 1:1 ratio to receive either extracorporeal shock wave therapy (ESWT) or low-level laser therapy (LLLT). In addition to the assigned intervention, all participants will be provided with a tennis elbow brace and a standardized exercise program.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share