Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
- Conditions
- Tennis ElbowEpicondylitis, LateralEpicondylitis of the Elbow
- Interventions
- Other: Extracorporeal Shockwave Treatment (Group A)Other: Nutraceutical Supplementation (Group B)Other: Combined Treatment (Group C)
- Registration Number
- NCT06442618
- Lead Sponsor
- University of Palermo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extracorporeal Shokwave Theraphy (Group A) Extracorporeal Shockwave Treatment (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. Nutraceutical Supplementation (Group B) 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. Combined Treatment (Group C) 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.
- Primary Outcome Measures
Name Time Method Extent of pain: Numeric Rating Scale (NRS 0-10) At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2) 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.
Intensity of pain and disability: Patient-Rated Tennis Elbow Evaluation Scale (PRTEE) At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2) 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
- Secondary Outcome Measures
Name Time Method 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) 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
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) 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.
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) The thickness of the common extensor tendon (CET) was assessed by ultrasound images.
Trial Locations
- Locations (1)
A.O.U.P. "P. Giaccone"
🇮🇹Palermo, Italy