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

University of Palermo

Status: Enrolling

Conditions: Tennis Elbow; Epicondylitis of the Elbow; Epicondylitis, Lateral

Treatments: Other: Combined Treatment (Group C); Other: Nutraceutical Supplementation (Group B); Other: Extracorporeal Shockwave Treatment (Group A)

Study type: Interventional

Funder types: Other

Identifiers

NCT06442618

MFR042024

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Extracorporeal Shokwave Theraphy (Group A)

Active Comparator group

Description:

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.

Treatment:

Other: Extracorporeal Shockwave Treatment (Group A)

Nutraceutical Supplementation (Group B)

Active Comparator group

Description:

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.

Treatment:

Other: Nutraceutical Supplementation (Group B)

Combined Treatment (Group C)

Active Comparator group

Description:

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.

Treatment:

Other: Combined Treatment (Group C)