Epicondylitis, LateralNCT06442618
Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
A study testing Extracorporeal Shockwave Treatment (Group A), Nutraceutical Supplementation (Group B) and Combined Treatment (Group C) in people with Epicondylitis, Lateral and Epicondylitis of the Elbow, run by University of Palermo at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Epicondylitis, Lateral, Epicondylitis of the Elbow, Tennis Elbow
- What is being tested?
- Extracorporeal Shockwave Treatment (Group A), Nutraceutical Supplementation (Group B) and Combined Treatment (Group C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- Cervical myelopathy;
- Epilepsy;
- Patients with contraindications and/or allergies to the active ingredients of nutracetical supplementation;
- Obesity with BMI\>30 (kg/m2).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
A.O.U.P. "P. Giaccone"
Palermo, 90127
Giulia Professor Letizia Mauro, +39 0916554061, giulia.letiziamauro@unipa.it
About this study
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.
- Being tested
- Extracorporeal Shockwave Treatment (Group A), Nutraceutical Supplementation (Group B), Combined Treatment (Group C)
- Keywords
- Epicondylitis, Extracorporeal ShockWave Treatment (ESWT), Nutraceutical Supplementation, Rehabilitation, Musculoskeletal Disease, Tendinopathy, Tennis Elbow
- Medical subject headings
- Tennis Elbow, Musculoskeletal Diseases, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Combined Treatment (Group C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
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
Measured: 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
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.
Measured: 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)
The thickness of the common extensor tendon (CET) was assessed by ultrasound images.
Measured: At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epicondylitis, LateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442618
- Sponsor's protocol ID
- MFR042024
- Status last verified
- Mar 2024
- First submitted
- 29 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27323324Pellegrino 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.
PubMed 36901381Kinney 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.
PubMed 37644995
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
- ClinicalTrials.gov ID
- NCT06442618
- Acronym / sponsor ID
- MFR042024
- Keywords
- Epicondylitis, Extracorporeal ShockWave Treatment (ESWT), Nutraceutical Supplementation, Rehabilitation, Musculoskeletal Disease, Tendinopathy, Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shokwave Theraphy (Group A) | Active comparator | Other: 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) | Active comparator | 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; 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) | Active comparator | 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 every day or 30 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Pregnancy;
- Already diagnosed or diagnostically defined neoplasms;
- Pacemaker wearers;
- Coagulation disorders and/or anticoagulant therapy;
- Skin lesions and/or local infections;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Extracorporeal Shokwave Theraphy (Group A) |
| 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. | Other | Nutraceutical Supplementation (Group B) |
| 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. | Other | Combined Treatment (Group C) |
Primary outcome
Extent of pain: Numeric Rating Scale (NRS 0-10)
Time frame: 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)
Time frame: 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
3 secondary outcomes
Disability: Disability of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: 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
Time frame: 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)
Time frame: At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 27323324Yang 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.
- Background: PubMed 36901381Pellegrino 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.
- Background: PubMed 37644995Kinney 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Treatment (Group A), Nutraceutical Supplementation (Group B) and Combined Treatment (Group C) in people with Epicondylitis, Lateral and Epicondylitis of the Elbow, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Letizia Mauro (+39 0916554160, giulia.letiziamauro@unipa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of pain: Numeric Rating Scale (NRS 0-10) (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06442618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.