Clinical trial NCT06442618: Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
Official title: Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epicondylitis, Lateral
Epicondylitis of the Elbow
Tennis Elbow
Keywords: Epicondylitis
Extracorporeal ShockWave Treatment (ESWT)
Nutraceutical Supplementation
Rehabilitation
Musculoskeletal Disease
Tendinopathy
Tennis Elbow
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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\&amp;gt;30 (kg/m2).

Primary outcomes:
measure: Extent of pain: Numeric Rating Scale (NRS 0-10)
timeFrame: At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
measure: Intensity of pain and disability: Patient-Rated Tennis Elbow Evaluation Scale (PRTEE)
timeFrame: 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:
measure: Disability: Disability of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
measure: Handgrip strength
timeFrame: At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
measure: Thickness of the common extensor tendon (CET)
timeFrame: At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: A.O.U.P. "P. Giaccone"
Study officials:
References:
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.
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.
citation: 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.