Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Lateral epicondylitis is a pathologic condition of the musculotendinous system, characterized by the presence of pain at the lateral epicondyle of the humerus; it is a tendinopathy of the extensor muscles of the forearm, often caused by overuse or repetitive use of the arm, forced extension of the elbow, or direct trauma to the humeral epicondyle. This study evaluated the efficacy of Extracorporeal ShockWave Treatment (ESWT) combined with a supplemental nutraceutical treatment of Hyaluronic Acid, Collagen, Vitamin C, and Manganese, compared with single treatment in patients with lateral epicondylitis in term of improvement in pain, functional capacity, muscle strength, and reduction of inflammation on ultrasound images. A clinical trial was conducted at the U.O.C. of Recovery and Functional Rehabilitation of A.O.U.P. P. Giaccone of Palermo from Marc 2024 to July 2024. Patients were randomized into 3 groups: in group A, n° 5 sessions of focal ESWT were given every six days; in group B, patients took daily for 30 days, supplemental nutraceutical treatment of Hyaluronic Acid, Collagen, Vitamin C, and Manganese; and group C, patients had combined treatment of ESWT (one session every six days for a total of five sessions) and nutraceutical supplementation (one administration per day for one month). All patients were evaluated at enrollment (T0), after one month, at the end of rehabilitation treatment (T1), and at a follow up 30 days after the end of treatment (T2). Researched will compare patients treated with ESWT or with nutraceutical treatment, and patients who had combined treatment to see if there are real differences in term of pain reduction and improved short- and long-term quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
A.O.U.P. P. Giaccone
RECRUITING
Palermo
Contact Information
Primary
Giulia Letizia Mauro
giulia.letiziamauro@unipa.it
+39 0916554160
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 45
Treatments
Active_comparator: Extracorporeal Shokwave Theraphy (Group A)
Group A participants were invited to come to our department's outpatient clinics, wearing comfortable clothing. Meetings were held every six days, for a total of 5 sessions (30 days), lasting about 20 minutes each.
Active_comparator: Nutraceutical Supplementation (Group B)
Participants in Group B performed home therapy with nutraceutical supplementation containing: hyaluronic acid (200 mg), collagen (5,000 mg), manganese (10 mg) and vitamin C (250 mg), daily for 30 days; they were advised to always take it at the same time and independently of meals, so as not to interfere with absorption.
Active_comparator: Combined Treatment (Group C)
Participants in group C were invited to come to our department's outpatient clinics to perform treatment with focal ESWT; they had one session every six days for a total of 5 sessions lasting about 20 minutes each. Patients in this group took also additional nutraceutical therapy every day or 30 days.
Related Therapeutic Areas
Sponsors
Leads: University of Palermo

This content was sourced from clinicaltrials.gov