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

Last updated: May 29, 2024
Sponsor: University of Palermo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tennis Elbow

Treatment

Nutraceutical Supplementation (Group B)

Extracorporeal Shockwave Treatment (Group A)

Combined Treatment (Group C)

Clinical Study ID

NCT06442618
MFR042024
  • Ages 18-50
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of lateral epicondylitis;

  • Ultrasound evidence of inflammatory status of the tendon of the wrist commonextensor muscle;

  • Numerical Rating Scale (NRS) at T0 ≥ 4;

  • Pharmacological wash out starting seven days before treatment;

  • Written informed consent.

Exclusion

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 ofnutracetical supplementation;

  • Obesity with BMI>30 (kg/m2).

Study Design

Total Participants: 45
Treatment Group(s): 3
Primary Treatment: Nutraceutical Supplementation (Group B)
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • A.O.U.P. "P. Giaccone"

    Palermo, 90127
    Italy

    Active - Recruiting

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