Dry Needling vs ESWT in Lateral Epicondylitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHaydarpasa Numune Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-guided dry needling

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Ultrasound-Guided Dry NeedlingExperimental treatment 1 intervention
Group B: Extracorporeal Shock Wave TherapyActive comparator 1 intervention

Trial outcomes

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.

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).

Secondary outcomes

1

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

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).
2

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).
3

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).
4

Change in quality of life measured by SF-12

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).

Other outcomes

Sponsors and contacts

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