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

Tennis Elbow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06442618
• Other study ID #: MFR042024
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Palermo
• Contact: Giulia Letizia Mauro
• Phone: +39 0916554160
• Email: giulia.letiziamauro[@]unipa.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Epicondylitis of the Elbow
• Epicondylitis, Lateral
• Tennis Elbow

Intervention

Other:
• 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
• 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.
• 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.

Locations

Country	Name	City	State
Italy	A.O.U.P. "P. Giaccone"	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Disability: Disability of the Arm, Shoulder and Hand (DASH) Questionnaire	This questinnaire is an important assessment tool, based on a district questionnaire, self-completed by the patient that aims to assess upper limb function; it consists of 38 questions, divided into 3 modules investigating different aspects of daily life, work activities, and sports/rehabilitation practices. The 38 items are scored from 1 to 5 (best score 1 and worst score 5) and refer to the patient's ability in the last 7 days	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	Handgrip strength	Handgrip strength was measured using a dynamometer; the patients squeezed the dynamometer maximally for 3 s. Three trials were attempted with 60 s of rest between each, and the average of all 3 grips were recorded.	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	Thickness of the common extensor tendon (CET)	The thickness of the common extensor tendon (CET) was assessed by ultrasound images.	At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)