Evaluation of Clinical Efficacy of Different Injection Therapies for Treating Humeral Epicondylopathy

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 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.

Conditions

• Elbow Tendinopathy

Interventions

PROCEDURE

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.

DRUG

Platelet Rich Plasma

Platelet rich plasma injection in the painful area of humeral epicondyle.

DRUG

Corticosteroid Injection

Corticosteroid injection in the painful area of humeral epicondyle.

DRUG

Hyaluronic Acid Injection

Hyaluronic acid injection in the painful area of humeral epicondyle.

OTHER

Placebo Injection

Saline injection in the painful area of humeral epicondyle.

Sponsors & Collaborators

• Wroclaw Medical University

  lead OTHER

Principal Investigators

• Pawel Reichert, PhD · Division of Sports Medicine/ Wroclaw Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-01

Primary Completion

2022-05-01

Completion

2022-05-31

FDA Drug

Yes

Countries

• Poland

Study Locations