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

NCT06442618 | Recruiting DMC

• 1 other identifier: MFR042024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Epicondylitis; Extracorporeal ShockWave Treatment (ESWT); Nutraceutical Supplementation; Rehabilitation; Musculoskeletal Disease; Tendinopathy; Tennis Elbow

Outcome Measures

Primary Outcomes (2)

• Extent of pain: Numeric Rating Scale (NRS 0-10)

  The NRS is a subjective scale that rates the extend of pain with a score between 0 and 10. a score of 10 corresponds to maximum pain.

  At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)

• Intensity of pain and disability: Patient-Rated Tennis Elbow Evaluation Scale (PRTEE)

  This scale consists of 2 parts, namely pain (5 items) and functional activities (10 items). Each item has a score from 0 (no pain or difficulty in performing a task) to 10 (the worst pain or inability to perform a task). The total score is the combined score of the 2 parts

  At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)

Secondary Outcomes (3)

• Disability: Disability of the Arm, Shoulder and Hand (DASH) Questionnaire

  At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)

• Handgrip strength

  At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)

• Thickness of the common extensor tendon (CET)

  At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)

Study Arms (3)

Extracorporeal Shokwave Theraphy (Group A)

ACTIVE COMPARATOR

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.

Other: Extracorporeal Shockwave Treatment (Group A)

Nutraceutical Supplementation (Group B)

ACTIVE COMPARATOR

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.

Other: Nutraceutical Supplementation (Group B)

Combined Treatment (Group C)

ACTIVE COMPARATOR

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.

Other: Combined Treatment (Group C)

Interventions

Extracorporeal Shockwave Treatment (Group A) 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

Extracorporeal Shokwave Theraphy (Group A)

Nutraceutical Supplementation (Group B) 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.

Nutraceutical Supplementation (Group B)

Combined Treatment (Group C) 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.

Combined Treatment (Group C)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

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

Palermo, 90127, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 27323324 BACKGROUND

• 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.

  PMID: 36901381 BACKGROUND

• 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.

  PMID: 37644995 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow; Musculoskeletal Diseases; Tendinopathy

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Muscular Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Giulia Letizia Mauro

CONTACT

+39 0916554160; giulia.letiziamauro@unipa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)