Haydarpasa Numune Training and Research Hospital
Istanbul, 34662, Turkey (Türkiye)
NCT Number: NCT07550322
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Istanbul, 34662, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Haydarpasa Numune Training and Research Hospital
Other
Ultrasound-Guided Dry Needling Versus Extracorporeal Shock Wave Therapy in Lateral Epicondylitis: A Randomized Single-Blind Controlled Trial
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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.
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