Evaluation of Clinical Efficacy of Different Injection Therapies for Treating Humeral Epicondylopathy
NCT ID: NCT04521387
Last Updated: 2022-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2021-02-01
2022-05-31
Brief Summary
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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.
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Detailed Description
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After meeting the inclusion and exclusion criteria and before therapeutic intervention patients will undergo clinical and radiological examination and laboratory analysis of blood samples - complete blood count, C reactive protein (CRP), selected cytokines. Elbow anterior-posterior and lateral view X-ray and ultrasound examination will be performed to find signs of enthesopathy, asses calcifications and to exclude other pathologies.
To measure the clinical effectiveness of the treatment examination including range of motion, limb girth measurements, grip and muscle strength measured by dedicated device (digital dynamometer) and regional pain severity measured by professional digital algometer will be performed. Patients will be asked to fulfil pain, functional and quality of live questionnaires, including Visual Analog Scale for pain intensity evaluation (VAS), Patient-rated Tennis Elbow Evaluation (PRTEE), Disabilities of the Arm, Shoulder, and Hand (DASH), The Mayo Elbow Performance Score (MEPS), The Oxford Elbow Score, The Subjective Elbow Value (SEV) and The Quality of life questionnaire SF-36.
Patients from the experimental group will receive an injection of autologous platelet-rich plasma (PRP) without activator (2ml) in the area of attachment of the common extensor tendon under supervision of ultrasound (N1=30), corticosteroid - 2ml of 7mg Betamethasone (N2=30) or 2ml of 40mg hyaluronic acid with mannitol (N3=30). Patients from control group will get an injection of saline (2ml 0,9% NaCl) in the same area (N=30). The injection will be carried out with aseptic precautions, under regional anesthesia with Lignocaine 1%. Saline injection as placebo intervention for control group was chosen because of a similar impression for the patient comparing to other injections. Also there are some previously reported positive outcomes of that kind of intervention alone. The procedure will be performed in accordance with the principle of double-blinding. Every patient will get identification number which will be randomly assigned to one from all groups, in equal proportion. Both, patient and investigator will not know what kind of substance was used for the treatment. Only person giving the injection will have access to patients identification numbers list and will know the exact type of treatment.
Part of the PRP sample (1ml) will undergo laboratory analysis of levels of bioactive compounds. Assessment of levels and concentrations of platelets, white blood cells and erythrocytes will be performed. The investigators will evaluate the content of selected cytokines in PRP using flow cytometry for growth hormones: Platelet Derived Growth Factor-AA (PDGF-AA), Platelet Derived Growth Factor-BB (PDGF-BB), Vascular Endothelial Growth Factor (VEGF), Epidermal Growth Factor (EGF), Hepatocyte Growth Factor (HGF), Fibroblast Growth Factor basic (FGF), Transforming Growth Factor Beta1 free active (TGFβ1) and inflammatory cytokines: Interleukin-1β (IL-1β), Interferon-α2 (IFN-α2), Interferon-γ (IFN-γ), Tumor Necrosis Factor -α (TNF-α), Monocyte Chemotactic Protein -1 (MCP-1), Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-10 (IL-10), Interleukin-12p70 (IL-12p70), Interleukin-17A (IL-17A), Interleukin-18 (IL-18), Interleukin-23 (IL-23), Interleukin-33 (IL-33).
Patients will be reassessed 1, 4, 12, 24 and 52 weeks after intervention. All patients will undergo ultrasound examination before treatment and during follow-up period. Every group will be instructed how to perform everyday stretching and strengthening exercises during the whole period of the study. All information about any complications will be collected and evaluated.
After data unblinding, statistical analysis will be performed. Subjective and objective outcomes, safety, costs-effectiveness of three different injection therapies compared to placebo and between each other will be assessed.
There are no original studies comparing clinical effectiveness between corticosteroid, hyaluronic acid, autologous platelet rich plasma and placebo in patients with elbow tendinopathy. There are only few good quality studies on the clinical effectiveness of lateral epicondylopathy treatment with different injection therapies. Most of them compare only one injection method to active comparator or placebo. Usually follow-up period is less than 3 months. Frequent follow-up visits will help to reliably evaluate rate of recurrence and to evaluate correlation between subjective and objective (e.g. USG) findings.
It is believed that results of this study will show significant positive clinical effect of different injection treatments of patients with lateral humeral epicondylopathy. The investigators would like to find which one from injection treatments among corticosteroids, autologous platelet rich plasma and hyaluronic acid will provide best outcomes, safety profile, short and long-term efficacy, cost-effectiveness and the fastest return to work. The results of the study will increase the knowledge about the treatment of lateral epicondylopathy, helping to create a reliable algorithm for supporting the decision-making process in everyday clinical practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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N1 Platelet Rich Plasma (PRP)
2ml of autologous platelet rich plasma injection
injection therapy
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.
Platelet Rich Plasma
Platelet rich plasma injection in the painful area of humeral epicondyle.
N2 Corticosteroid (CS)
2ml of 7mg Betamethasone injection
injection therapy
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.
Corticosteroid Injection
Corticosteroid injection in the painful area of humeral epicondyle.
N3 Hyaluronic Acid (HA)
2ml of 40mg hyaluronic acid with mannitol injection
injection therapy
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.
Hyaluronic Acid Injection
Hyaluronic acid injection in the painful area of humeral epicondyle.
N4 Saline (NaCl)
2ml saline (0,9%NaCl) injection
injection therapy
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.
Placebo Injection
Saline injection in the painful area of humeral epicondyle.
Interventions
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injection therapy
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.
Platelet Rich Plasma
Platelet rich plasma injection in the painful area of humeral epicondyle.
Corticosteroid Injection
Corticosteroid injection in the painful area of humeral epicondyle.
Hyaluronic Acid Injection
Hyaluronic acid injection in the painful area of humeral epicondyle.
Placebo Injection
Saline injection in the painful area of humeral epicondyle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* confirmation of lateral epicondylitis in at least one provocative test,
* no previous invasive treatment,
* no improvement after rehabilitation
Exclusion Criteria
* hematological diseases,
* diabetes,
* tumors of upper extremity,
* gout,
* advanced osteoarthritis,
* previously performed operations around the elbow joint,
* suspicion of the infectious process,
* pregnant
30 Years
60 Years
ALL
No
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Principal Investigators
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Pawel Reichert, PhD
Role: PRINCIPAL_INVESTIGATOR
Division of Sports Medicine/ Wroclaw Medical University
Locations
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Sport Division, Wroclaw Medical University
Wroclaw, Woj. Dolnośląskie, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DZ-4000-218/19
Identifier Type: -
Identifier Source: org_study_id
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