Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07550322

Dry Needling vs ESWT in Lateral Epicondylitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Lateral Epicondylitis (Tennis Elbow) Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydarpasa Numune Training and Research Hospital

Istanbul, 34662, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided dry needling

Procedure

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.

Extracorporeal Shock Wave Therapy

Device

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.

Primary outcomes

  1. Change in pain intensity measured by Visual Analog Scale (VAS)

    Time frame: 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).

    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.

Secondary outcomes

  1. Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) score

    Time frame: 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).

    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.

  2. Change in grip strength

    Time frame: 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).

    Grip strength will be measured using a hand dynamometer in kilograms.

  3. Change in pressure pain threshold

    Time frame: 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).

    Pressure pain threshold will be measured using a handheld algometer over the lateral epicondyle.

  4. Change in quality of life measured by SF-12

    Time frame: 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).

    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.

  5. Change in ultrasonographic tendon thickness

    Time frame: 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).

    Common extensor tendon thickness will be measured using musculoskeletal ultrasound.

  6. Change in Power Doppler neovascularization score

    Time frame: 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).

    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.

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.