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

NCT ID: NCT06442618

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-12-31

Brief 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.

Conditions

Epicondylitis, Lateral; Epicondylitis of the Elbow; Tennis Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Extracorporeal Shockwave Treatment (Group A)

Intervention Type: OTHER

Each session involved a 1:1 ratio of patient to physiatrist. The treatment modality was explained to the patient preliminarily, and before each session, the patients were clinically evaluated and the location of pain was identified.; so patients were asked to assume a comfortable position, and treatment with focal ESWTs was started as per the ISMST protocol

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.

Group Type: ACTIVE_COMPARATOR

Nutraceutical Supplementation (Group B)

Intervention Type: OTHER

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. Patients were advised to shake the compound, before taking, and to store it at room temperature not exceeding 25 °C, in a cool, dry place, away from light and heat sources. The compound is also free of gluten and lactose, so it can be safely administered.

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.

Group Type: ACTIVE_COMPARATOR

Combined Treatment (Group C)

Intervention Type: OTHER

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; they took a daily supplemental treatment of hyaluronic acid, collagen, vitamin C and manganese for 30 days.

Interventions

Extracorporeal Shockwave Treatment (Group A)

Each session involved a 1:1 ratio of patient to physiatrist. The treatment modality was explained to the patient preliminarily, and before each session, the patients were clinically evaluated and the location of pain was identified.; so patients were asked to assume a comfortable position, and treatment with focal ESWTs was started as per the ISMST protocol

Intervention Type: OTHER

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. Patients were advised to shake the compound, before taking, and to store it at room temperature not exceeding 25 °C, in a cool, dry place, away from light and heat sources. The compound is also free of gluten and lactose, so it can be safely administered.

Intervention Type: OTHER

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; they took a daily supplemental treatment of hyaluronic acid, collagen, vitamin C and manganese for 30 days.

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Prof.ssa Giulia Letizia Mauro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

A.O.U.P. "P. Giaccone"

Palermo, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giulia Letizia Mauro

Role: CONTACT

giulia.letiziamauro@unipa.it

+39 0916554160

Facility Contacts

Giulia Professor Letizia Mauro

Role: primary

giulia.letiziamauro@unipa.it

+39 0916554061

References

Yang TH, Huang YC, Lau YC, Wang LY. Efficacy of Radial Extracorporeal Shock Wave Therapy on Lateral Epicondylosis, and Changes in the Common Extensor Tendon Stiffness with Pretherapy and Posttherapy in Real-Time Sonoelastography: A Randomized Controlled Study. Am J Phys Med Rehabil. 2017 Feb;96(2):93-100. doi: 10.1097/PHM.0000000000000547.

Reference Type: BACKGROUND

PMID: 27323324 (View on PubMed)

Pellegrino R, Di Iorio A, Filoni S, Mondardini P, Paolucci T, Sparvieri E, Tarantino D, Moretti A, Iolascon G. Radial or Focal Extracorporeal Shock Wave Therapy in Lateral Elbow Tendinopathy: A Real-Life Retrospective Study. Int J Environ Res Public Health. 2023 Feb 28;20(5):4371. doi: 10.3390/ijerph20054371.

Reference Type: BACKGROUND

PMID: 36901381 (View on PubMed)

Kinney WR, Anderson BR. Nonoperative Management of Lateral Epicondyle Tendinopathy: An Umbrella Review. J Chiropr Med. 2023 Sep;22(3):204-211. doi: 10.1016/j.jcm.2023.04.004. Epub 2023 Jul 10.

Reference Type: BACKGROUND

PMID: 37644995 (View on PubMed)

Other Identifiers

MFR042024

Identifier Type: -

Identifier Source: org_study_id