Dry Needling vs ESWT in Lateral Epicondylitis

NCT07550322 | Not Yet Recruiting

• 1 other identifier: 2024-KAEK-18-5087
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lateral Epicondylitis (Tennis Elbow)

Keywords

Lateral epicondylitis; Dry needling; Ultrasound-guided dry needling; Extracorporeal shock wave therapy; ESWT; Musculoskeletal ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (6)

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

  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 grip strength

  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

  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

  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

  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).

Study Arms (2)

Ultrasound-Guided Dry Needling

EXPERIMENTAL

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

Extracorporeal Shock Wave Therapy

ACTIVE COMPARATOR

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

Interventions

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.

Ultrasound-Guided Dry Needling

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.

Extracorporeal Shock Wave Therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Haydarpasa Numune Training and Research Hospital

Istanbul, Istanbul, 34662, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Berna Gunay, MD

CONTACT

+90 535 413 3047; bernagunay@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessments, ultrasonographic evaluations, and statistical analyses will be performed by investigators blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Physical Medicine and Rehabilitation

Model Details: Two parallel groups will be randomized in a 1:1 ratio to receive either ultrasound-guided dry needling or extracorporeal shock wave therapy. Both groups will receive five treatment sessions and will be followed for six months.

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)