Using shockwave therapy and supplements to treat tennis elbow
Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
This study is testing if a combination of shockwave therapy and dietary supplements can help people with tennis elbow feel less pain and improve their arm function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Locations | 1 site (Palermo) |
| Trial ID | NCT06442618 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Extracorporeal ShockWave Treatment (ESWT) combined with nutraceutical supplementation in patients suffering from lateral epicondylitis, commonly known as tennis elbow. Participants are randomized into three groups: one receiving only ESWT, another receiving only nutraceuticals, and a third receiving both treatments. The study aims to assess improvements in pain, functional capacity, muscle strength, and inflammation reduction through ultrasound imaging. Conducted at the University of Palermo, the trial runs from March 2024 to July 2024.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with lateral epicondylitis who have a minimum pain score of 4 on the Numerical Rating Scale.
Not a fit: Patients with contraindications such as pregnancy, neoplasms, or severe obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate pain and improve function for patients with tennis elbow.
How similar studies have performed: Previous studies have shown promise with shockwave therapy for musculoskeletal conditions, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of lateral epicondylitis; * Ultrasound evidence of inflammatory status of the tendon of the wrist common extensor muscle; * Numerical Rating Scale (NRS) at T0 ≥ 4; * Pharmacological wash out starting seven days before treatment; * Written informed consent. Exclusion Criteria: * Pregnancy; * Already diagnosed or diagnostically defined neoplasms; * Pacemaker wearers; * Coagulation disorders and/or anticoagulant therapy; * Skin lesions and/or local infections; * Tendon injury and/or previous surgery on the wrist extensor tendons; * Cervical myelopathy; * Epilepsy; * Patients with contraindications and/or allergies to the active ingredients of nutracetical supplementation; * Obesity with BMI\>30 (kg/m2).
Where this trial is running
Palermo
- A.O.U.P. "P. Giaccone" — Palermo, Italy (Recruiting)
Study contacts
- Study coordinator: Giulia Letizia Mauro
- Email: giulia.letiziamauro@unipa.it
- Phone: +39 0916554160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.