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

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wroclaw Medical University
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• pain on the lateral or medial side of the elbow joint for at least three months,

• confirmation of lateral or medial epicondylitis in at least one provocative test,

• no previous invasive treatment,

• no improvement after rehabilitation

Exclusion Criteria:

• nervous system diseases related to the upper limb,

• hematological diseases,

• diabetes,

• tumors of upper extremity,

• gout,

• advanced osteoarthritis,

• previously performed operations around the elbow joint,

• suspicion of the infectious process,

• pregnant