Lateral Epicondylitis (Tennis Elbow)
Conditions
Keywords
Lateral epicondylitis, Dry needling, Ultrasound-guided dry needling, Extracorporeal shock wave therapy, ESWT, Musculoskeletal ultrasound
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.
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.
Interventions
PROCEDUREUltrasound-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.
DEVICEExtracorporeal 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.
Sponsors
Haydarpasa Numune Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Outcome assessments, ultrasonographic evaluations, and statistical analyses will be performed by investigators blinded to treatment allocation.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity measured by Visual Analog Scale (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | PRTEE questionnaire will be used to evaluate pain and functional disability in lateral epicondylitis. |
| 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). | Grip strength will be measured using a hand dynamometer in kilograms. |
| 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). | Pressure pain threshold will be measured using a handheld algometer over the lateral epicondyle. |
| 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). | Quality of life will be assessed using the Short Form-12 questionnaire. |
| 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). | Common extensor tendon thickness will be measured using musculoskeletal ultrasound. |
| Change in Power Doppler neovascularization 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). | Neovascularization will be evaluated using semi-quantitative Power Doppler scoring. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBerna Gunay, MD
Outcome results
None listed