Dry Needling vs ESWT in Lateral Epicondylitis

Ultrasound-Guided Dry Needling Versus Extracorporeal Shock Wave Therapy in Lateral Epicondylitis: A Randomized Single-Blind Controlled Trial

This randomized single-blind controlled trial aims to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Sixty participants aged 18-65 years will be randomized into two groups. The dry needling group will receive ultrasound-guided tendon fenestration once weekly for five sessions, while the ESWT group will receive radial extracorporeal shock wave therapy once weekly for five sessions. All participants will be given a standardized home exercise program. Pain, function, grip strength, pressure pain threshold, quality of life, and ultrasonographic findings will be evaluated at baseline, post-treatment, and at 3- and 6-month follow-up. The primary outcome is change in pain severity measured by Visual Analog Scale.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis (Tennis Elbow)
• Intervention / Treatment: Procedure: Ultrasound-guided dry needling; Device: Extracorporeal Shock Wave Therapy

Detailed Description

This prospective, randomized, parallel-group, single-blind clinical trial is designed to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Participants aged 18-65 years with symptoms lasting at least six weeks will be randomly assigned in a 1:1 ratio using computer-generated block randomization with sealed opaque envelopes. Due to the nature of the interventions, participants and treating physicians will not be blinded; however, all clinical and ultrasonographic assessments will be performed by an investigator blinded to treatment allocation.

Participants in the dry needling group will receive ultrasound-guided tendon fenestration targeting the pathologic area of the common extensor tendon. The procedure will be performed once weekly for five sessions. Participants in the ESWT group will receive radial extracorporeal shock wave therapy applied to the most tender point over the lateral epicondyle using standard treatment parameters. ESWT will also be administered once weekly for five sessions.

All participants will receive a standardized home exercise program consisting of eccentric strengthening and stretching exercises for the wrist extensors. Assessments will be performed at baseline, immediately after treatment, and at 3- and 6-month follow-up visits. Outcome measures will include pain intensity, functional status, grip strength, pressure pain threshold, quality of life, and ultrasonographic tendon characteristics including grayscale and Power Doppler findings.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34662
      • Haydarpasa Numune Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 to 65 years
• Clinical diagnosis of lateral epicondylitis
• Symptoms persisting for at least 6 weeks
• Pain over the lateral epicondyle aggravated by wrist extension or gripping activities
• Positive provocative tests consistent with lateral epicondylitis (e.g., Cozen's test and/or Mill's test)
• Ability to understand the study procedures and provide written informed consent

Exclusion Criteria:

• Previous surgery for lateral epicondylitis in the affected elbow
• Corticosteroid injection, PRP injection, prolotherapy, mesotherapy, or ESWT to the affected elbow within the previous 6 months
• Bilateral lateral epicondylitis requiring simultaneous treatment
• Cervical radiculopathy or other neurologic disorders affecting the upper extremity
• Inflammatory rheumatic disease
• Elbow osteoarthritis or significant structural elbow pathology
• Full-thickness tendon tear or other major tendon injury on imaging
• Pregnancy or breastfeeding
• Active infection, skin lesion, or wound at the treatment site
• Use of anticoagulant therapy or bleeding disorder
• Inability to comply with follow-up assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-Guided Dry Needling; Participants will receive ultrasound-guided dry needling applied to the common extensor tendon once weekly for five sessions. All participants will also perform a standardized home exercise program.	Procedure: Ultrasound-guided dry needling; Dry needling will be performed under ultrasound guidance targeting the tendinosis area of the common extensor tendon. The procedure will be applied once weekly for five sessions.
Active Comparator: Extracorporeal Shock Wave Therapy; Participants will receive radial extracorporeal shock wave therapy applied to the lateral epicondyle once weekly for five sessions. All participants will also perform a standardized home exercise program.	Device: Extracorporeal Shock Wave Therapy; Radial extracorporeal shock wave therapy will be applied using standard parameters (10-15 Hz, 1.5-2.5 bar, 2000 pulses) once weekly for five sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity measured by Visual Analog Scale (VAS)	Pain intensity will be assessed using a 10-cm visual analog scale. Change from baseline to immediate post-treatment, upto 3 months, and upto 6 months will be analyzed. The Visual Analogue Scale (VAS) was used to assess the severity of elbow pain during activity. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity and therefore a worse outcome.	Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in grip strength	Grip strength will be measured using a hand dynamometer in kilograms.	Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in pressure pain threshold	Pressure pain threshold will be measured using a handheld algometer over the lateral epicondyle.	Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in ultrasonographic tendon thickness	Common extensor tendon thickness will be measured using musculoskeletal ultrasound.	Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) score	PRTEE questionnaire will be used to evaluate pain and functional disability in lateral epicondylitis. The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item, elbow-specific questionnaire assessing pain and functional disability. It comprises a Pain subscale (5 items; score range, 0-50) and a Function subscale (10 items; converted score range, 0-50). The total PRTEE score ranges from 0 to 100, where 0 indicates no pain or functional disability and 100 indicates the greatest possible pain and disability. Higher scores indicate a worse outcome.	Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in quality of life measured by SF-12	Quality of life will be assessed using the Short Form-12 questionnaire. The 12-Item Short Form Health Survey (SF-12) was used to assess health-related quality of life. It generates two separate summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each component score ranges from 0 to 100, where 0 represents the worst health status and 100 represents the best health status. Higher scores indicate better physical or mental health and therefore a better outcome. The PCS and MCS scores were evaluated separately; no overall SF-12 total score was calculated.	Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in Power Doppler neovascularization score	Neovascularization will be evaluated using semi-quantitative Power Doppler scoring. The Color Doppler Ultrasound Neovascularization Score was used to grade vascular activity within the common extensor tendon. Scores range from 0 to 4: grade 0 indicates no Doppler activity; grade 1 indicates a single vessel; grade 2 indicates Doppler activity occupying less than 25% of the region of interest; grade 3 indicates activity occupying 25%-50% of the region of interest; and grade 4 indicates activity occupying more than 50% of the region of interest. Higher scores indicate greater neovascularization and a worse ultrasonographic tendon outcome.	Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Actual): September 14, 2026
• Study Completion (Actual): September 14, 2026

Study Registration Dates

• First Submitted: April 11, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dry needling; Lateral epicondylitis; ESWT; Extracorporeal shock wave therapy; Musculoskeletal ultrasound; Ultrasound-guided dry needling
• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: 2024-KAEK-18-5087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. De-identified data may be available from the corresponding investigator upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No