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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
Haydarpasa Numune Training and Research Hospital
Istanbul, Istanbul, Turkey (Türkiye)
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.
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).
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.
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).
Change in grip strength
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).
Change in pressure pain threshold
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).
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.
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).
Change in ultrasonographic tendon thickness
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).
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.
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).
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