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

NCT04521387 | Unknown Phase 4 FDA Drug

• 1 other identifier: DZ-4000-218/19
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tennis elbow; Lateral humeral epicondylopathy; Lateral epicondylitis; injection therapies; platelet rich plasma; hyaluronic acid injection; steroid injection; lateral elbow tendinopathy; epicondylopathia humeri

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• 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

Other Outcomes (2)

• Rate of adverse events

  0, 1, 4, 12, 24, 52 weeks

• Comparison of treatment cost-effectiveness

  52 weeks

Study Arms (4)

N1 Platelet Rich Plasma (PRP)

EXPERIMENTAL

2ml of autologous platelet rich plasma injection

Procedure: injection therapy; Drug: Platelet Rich Plasma

N2 Corticosteroid (CS)

ACTIVE COMPARATOR

2ml of 7mg Betamethasone injection

Procedure: injection therapy; Drug: Corticosteroid Injection

N3 Hyaluronic Acid (HA)

ACTIVE COMPARATOR

2ml of 40mg hyaluronic acid with mannitol injection

Procedure: injection therapy; Drug: Hyaluronic Acid Injection

N4 Saline (NaCl)

PLACEBO COMPARATOR

2ml saline (0,9%NaCl) injection

Procedure: injection therapy; Other: Placebo Injection

Interventions

injection therapy PROCEDURE

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.

Also known as: injection

N1 Platelet Rich Plasma (PRP); N2 Corticosteroid (CS); N3 Hyaluronic Acid (HA); N4 Saline (NaCl)

Platelet Rich Plasma DRUG

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

Also known as: PRP

N1 Platelet Rich Plasma (PRP)

Corticosteroid Injection DRUG

Corticosteroid injection in the painful area of humeral epicondyle.

Also known as: CS

N2 Corticosteroid (CS)

Hyaluronic Acid Injection DRUG

Hyaluronic acid injection in the painful area of humeral epicondyle.

Also known as: HA

N3 Hyaluronic Acid (HA)

Placebo Injection OTHER

Saline injection in the painful area of humeral epicondyle.

Also known as: NaCl

N4 Saline (NaCl)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pain on the lateral side of the elbow joint for at least three months,
• confirmation of lateral epicondylitis in at least one provocative test,
• no previous invasive treatment,
• no improvement after rehabilitation

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Sport Division, Wroclaw Medical University

Wroclaw, Woj. Dolnośląskie, 51-618, Poland

RECRUITING

MeSH Terms

Conditions

Elbow Tendinopathy; Tennis Elbow

Interventions

Injections; Adrenal Cortex Hormones; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Pawel Reichert, PhD

  Division of Sports Medicine/ Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maciej Dejnek

CONTACT

793999245; maciej.dejnek@student.umed.wroc.pl

Pawel Reichert, PhD

CONTACT

pawel.reichert@umed.wroc.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: August 20, 2020
• Study Start: February 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 31, 2022
• Last Updated: March 11, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)