Evaluation of Clinical Efficacy of Different Injection Therapies for Treating Humeral Epicondylopathy
Status:
Recruiting
Trial end date:
2022-05-31
Target enrollment:
Participant gender:
Summary
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 and medial
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 200 patients aged 30-50 who suffer for lateral or medial epicondylitis. After
meeting the inclusion and exclusion criteria patients will receive an injection of
leukocyte-poor autologous PRP (N1), corticosteroid (N2), HA (N3) in the area of the common
extensors or flexor 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.