- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06040203
Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis: a Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roberta Licciardi, MSc
- Phone Number: 051 6366567
- Email: roberta.licciardi@ior.it
Study Contact Backup
- Name: Enrico Guerra, MD
- Phone Number: 0516366567
- Email: enrico.guerra@ior.it
Study Locations
-
-
-
Bologna, Italy, 40136
- Recruiting
- Istituto Ortopedico Rizzoli
-
Contact:
- Roberta Licciardi, MSc
- Phone Number: 051 6366567
- Email: roberta.licciardi@ior.it
-
Contact:
- Enrico Guerra, MD
- Phone Number: 6366567
- Email: enrico.guerra@ior.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients with epicondylitis of the elbow:
- Patients with clinical picture of epicondylitis;
- Duration of symptoms > 3 months
- Ultrasound picture of short or long radial extensor carpal tendinopathy;
- Age > 18 and < 65
- Both sexes;
- Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months;
- Hemoglobin > 11 g/dl;
- Platelet count > 150,000 plt/mm3 (Recently performed CBC examination);
- Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- No clinically significant electrocardiographic changes (Recently performed ECG);
- Ability and consent of the patient to actively participate in clinical follow-up;
- Signature of informed consent.
Exclusion Criteria:
- Patients undergoing previous surgical treatment on the epicondylar tendons;
- Patients undergoing epicondylar infiltration in the previous 6 months;
- Inability of patients to actively participate in clinical follow-up;
- Incapacitated patients;
- Patients with states of immunodepression;
- Patients with fibromyalgia;
- Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications);
- Patients with uncontrolled thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
- Patients who have taken NSAIDs in the 3 days prior to blood collection;
- Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw;
- Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated;
- Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Leukocyte-rich Platelet rich plasma (LR-PRP)
This group of patients will be treated with single injection of autologous leukocyte rich platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.
|
Patients will be treated with a single eco-guided injection of Autologous LR-PRP in the elbow affected by epicondylitis.
|
Experimental: Leukocyte-poor Platelet rich plasma (LP-PRP)
This group of patients will be treated withsSingle injection of autologous leukocyte poor platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.
|
Patients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis.
|
Placebo Comparator: Saline solution
This group of patients will be treated with single intra-articular injection of saline solution (placebo).
At the 6-month follow-up visit, patients will be informed about the treatment received.
Patients of this group can cross-over to the treatment arm after 6 months following a dedicated randomization list.
|
Patients will be treated with a single injections of saline solution in the elbow affected by epicondylitis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-rated Tennis Elbow Evaluation (PRTEE)
Time Frame: 6 months follow-up
|
PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) Pain subscale (0 = no pain, 10 = worst imaginable) item 2) Function subscale (0 = no difficulty, 10 = unable to do). The total score is the sum of the two subscales and has a range from 0 to 100. |
6 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Acceptable Symptom State (PASS)
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
|
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity.
Patients can express if their state of health will be satisfying, answering "yes" or "no.
|
baseline, 1 month, 3 months, 6 and 12 months follow-up
|
Patient-rated Tennis Elbow Evaluation (PRTEE)
Time Frame: baseline, 1 month, 3 months and 12 months follow-up
|
PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) Pain subscale (0 = no pain, 10 = worst imaginable) item 2) Function subscale (0 = no difficulty, 10 = unable to do). The total score is the sum of the two subscales and has a range from 0 to 100. |
baseline, 1 month, 3 months and 12 months follow-up
|
Disability of the arm, shoulder and hand score (DASH)
Time Frame: baseline, 1 month, 3 months, 6 months and 12 months follow-up
|
The Disabilities of the Arm, Shoulder and Hand (DASH) Score is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales.
Scores range from 0 (no disability) to 100 (most severe disability).
This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
|
baseline, 1 month, 3 months, 6 months and 12 months follow-up
|
Visual Analogue Scale (VAS)
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
|
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10).
|
baseline, 1 month, 3 months, 6 and 12 months follow-up
|
EuroQol Visual Analogue Scale (EQ-VAS)
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
|
EQ-VAS is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
|
baseline, 1 month, 3 months, 6 and 12 months follow-up
|
Pain detect
Time Frame: baseline
|
The Pain Detect-Questionnaire is a reliable screening tool for neuropathic pain with high sensitivity, specificity, and positive predictive accuracy.
In this scale, the score ranges from 0 to 38 (range 0-12 neuropathic component of pain unlikely, range 13-18 neuropathic component of pain probably present, range 19-38 neuropathic component of pain present).
|
baseline
|
Final treatment opinion
Time Frame: 1 month, 3 months, 6 and 12 months follow-up
|
The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up).
All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse".
|
1 month, 3 months, 6 and 12 months follow-up
|
Effectiveness of the blinding procedure
Time Frame: baseline
|
The patient should indicate, after the infiltrative procedure, the type of treatment they think they received.
|
baseline
|
Expectations of treatment efficacy
Time Frame: baseline
|
The patient should indicate at baseline what benefits they expect from the treatment
|
baseline
|
Tegner Activity Level Scale
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
|
Tegner Activity Level Scale is a questionnaire to find out the patient's level of physical activity.All patients will indicate the type of sporting activity performed and its frequency. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability and 10 represents a competitive level of sport. |
baseline, 1 month, 3 months, 6 and 12 months follow-up
|
Oxford Elbow Score (OES)
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
|
Oxford Elbow score is a questionnaire consisting of 12 questions (related to pain, function, and socio-psychological aspects) specifically designed and developed to evaluate the outcomes of elbow surgery. The Oxford Elbow score has 12 items (questions) with 5 response options each. Each item response is scored as 0 to 4, with 0 representing greater severity. Underlying the 12 items are 3 domains (subscales): elbow pain, elbow function and social-psychological effects. Scores for each domain are calculated as the sum of each individual item score within that domain. This gives a score range of 0-16 for each domain and 0-48 overall, with 0 indicating the worst elbow score and 48 as a 'normal' elbow score |
baseline, 1 month, 3 months, 6 and 12 months follow-up
|
EQ-5D (EuroQoL) Current Health Assessment
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
|
The generic health-related quality of life instrument-EQ-5D-allows both a description of health status along 5 dimensions and the evaluation of health or the estimation of a health summary score: the EQ-5D score on a scale where 0 is death and 1 is full health.
EQ-5D is useful to evaluate the quality life of the patients.
The EQ-5D respondents classify their own health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 levels of severity (no problems, moderate problems, or severe problems).
|
baseline, 1 month, 3 months, 6 and 12 months follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Enrico Guerra, MD, Istituto Ortopedico Rizzoli - SC Chirurgia della spalla e del gomito
Publications and helpful links
General Publications
- Kim GM, Yoo SJ, Choi S, Park YG. Current Trends for Treating Lateral Epicondylitis. Clin Shoulder Elb. 2019 Dec 1;22(4):227-234. doi: 10.5397/cise.2019.22.4.227. eCollection 2019 Dec.
- Chen J, Wang A, Xu J, Zheng M. In chronic lateral epicondylitis, apoptosis and autophagic cell death occur in the extensor carpi radialis brevis tendon. J Shoulder Elbow Surg. 2010 Apr;19(3):355-62. doi: 10.1016/j.jse.2009.07.064.
- Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale ST, Kelly FB. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013 Dec;21(12):739-48. doi: 10.5435/JAAOS-21-12-739.
- Chen X, Jones IA, Park C, Vangsness CT Jr. The Efficacy of Platelet-Rich Plasma on Tendon and Ligament Healing: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2018 Jul;46(8):2020-2032. doi: 10.1177/0363546517743746. Epub 2017 Dec 21.
- Karaduman M, Okkaoglu MC, Sesen H, Taskesen A, Ozdemir M, Altay M. Platelet-rich plasma versus open surgical release in chronic tennis elbow: A retrospective comparative study. J Orthop. 2016 Jan 22;13(1):10-4. doi: 10.1016/j.jor.2015.12.005. eCollection 2016 Mar.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Epic-PRP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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