Loading search results
Sponsor study identifier
interventional
120
1 country
1
Study Start
February 1, 2021
Actual (reported)Primary Completion
May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Humeral epicondylopathies are common disorders which can significantly impair upper limb function. In case of failure of rehabilitation protocol there is no evidence based second line therapy. It is common practice to perform one of the injection procedures. The biological mechanisms of these procedures are unclear, and may even be contrary. These include, but are not limited to, injections of corticosteroids, autologous platelet rich plasma (PRP) and hyaluronic acid (HA). Despite the frequent use there is much controversy about their clinical effectiveness and more evidence based data are required. The aim of the study is to compare three different injection therapies for lateral epicondylopathy. In addition, correlation between selected bioactive compounds in PRP and its clinical effectiveness will be evaluated. The study is planned as a single-center, prospective, randomized, double-blinded, controlled trial on 120 patients aged 30-60 who suffer for lateral epicondylitis. After meeting the inclusion and exclusion criteria patients will receive an injection of leukocyte-rich autologous PRP (N1), corticosteroid (N2), HA (N3) in the area of the common extensors tendon attachment, respectively. Patients from control group (N4) will get an injection of saline in the same area. All groups will be instructed how to perform everyday stretching and strengthening exercises. Evaluation of clinical effectiveness of the treatment will be based on objective measurements such as range of motion, limb girth, grip strength, X-ray and ultrasound examination and subjective measurements such as pain (VAS), functional (PRTEE, DASH, SEV, MEPS) and quality of life questionnaires (SF-36) before and during follow-up period (1, 4, 12, 24, 52 weeks). PRP samples will undergo laboratory analysis of levels of bioactive compounds including platelets, white blood cells, erythrocytes and selected growth factors and inflammatory cytokines. After data collection, the clinical effectiveness of three different injection therapies will be evaluated and statistically analyzed. Subjective and objective outcomes, safety, costs-effectiveness of three different injection therapies compared to placebo and between each other will be assessed. In addition, correlation between levels of bioactive compounds in PRP and its efficacy will be checked.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2020
Actual (reported)August 20, 2020
Actual (reported)February 1, 2021
Actual (reported)May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in pain level assessed by Visual Analog Scale
the change of pain level in the region of lateral or medial humeral epicondyle after treatment represented on Visual Analog Scale (VAS) scoring from 0 (no-pain) to 10 (worst imaginable pain)
0, 1, 4, 12, 24, 52 weeks
Change in functional outcome assessed by Patient-rated Tennis Elbow Evaluation
the change in the results of functional questionnaire - Patient-rated Tennis Elbow Evaluation (PRTEE), scale from 0 to 100, lower value means less disability
0, 4, 12, 24, 52 weeks
Change in muscle strength assessed by hand held dynamometer
0, 4, 12, 24, 52 weeks
Change in ultrasound examination image
0, 4, 12, 24, 52 weeks
Change in results of quality of life questionnaire SF-36
0, 4, 12, 24, 52 weeks
Change in functional outcome assessed by Disabilities of the Arm, Shoulder, and Hand
0, 4, 12, 24, 52 weeks
Change in functional outcome assessed by The Subjective Elbow Value
0, 4, 12, 24, 52 weeks
Rate of adverse events
0, 1, 4, 12, 24, 52 weeks
Comparison of treatment cost-effectiveness
52 weeks
2ml of autologous platelet rich plasma injection
2ml of 7mg Betamethasone injection
The injection will be carried out with aseptic precautions, under regional anesthesia with 1ml of 1% Lignocaine through one puncture of the skin and frequent changes in the inside needle position.
Sport Division, Wroclaw Medical University
Wroclaw, Woj. Dolnośląskie, 51-618, Poland
Pawel Reichert, PhD
Division of Sports Medicine/ Wroclaw Medical University
First Submitted
May 21, 2020
First Posted
August 20, 2020
Study Start
February 1, 2021
Actual (reported)Primary Completion
May 1, 2022
Estimated (date passed)2ml of 40mg hyaluronic acid with mannitol injection
2ml saline (0,9%NaCl) injection
Platelet rich plasma injection in the painful area of humeral epicondyle.
Corticosteroid injection in the painful area of humeral epicondyle.
Hyaluronic acid injection in the painful area of humeral epicondyle.
Saline injection in the painful area of humeral epicondyle.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 11, 2022
Record last verified: 2021-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: