NCT04395417

Injection Therapy in Patients With Lateral Epicondylitis

Injection Therapy in Patients With Lateral Epicondylitis: Hyaluronic Acid or Prolotherapy?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Lateral epicondylitis is a painful enthesopathy of the common extensor tendon at the lateral part of the elbow, with a prevalence of 1-3 % in the general population. In the treatment of lateral epicondylitis, the role of biological-based therapies has begun to investigate regeneration and optimize tendon healing. Prolotherapy (PrT) and hyaluronic acid (HA) injections are biological based treatments. Previous studies have shown benefit of PrT in the treatment of tendinopathies. Preliminary findings demonstrated that HA could be clinically effective in the treatment of enthesopathies. Considering the paucity of HA studies (which also lack a control group) and the proposed mechanism of action of both PrT and HA is through cell proliferation and the healing process of tendons, this study was conducted to compare the effect of PrT and HA in chronic lateral epicondylitis .

Detailed description

Lateral epicondylitis and other chronic tendinopathies are now understood to be non-inflammatory conditions characterized by collagen degeneration, fibroblast proliferation, mucoid degeneration and neovascularization Biological-based treatments can trigger the release of cytokines and growth factors from platelets, leukocytes, macrophages and other inflammatory cells. These growth factors support neovascularization and the chemotaxis of fibroblasts and tenocytes. It stimulates proliferation and collagen remodeling of fibroblasts and tenocytes. PrT involves multiple injections of a small amount of irritant or sclerosing solution. Common irritants include hypertonic dextrose, phenol-glycerin-glucose and sodium morrhuate. PrT injection mechanism is as follows; while hypertonic dextrose causes cell rupture through osmosis, monosodium morrhuate attracts inflammatory mediators and improves blood flow of the diseased tendon.Previous studies have shown benefit of PrT in the treatment of tendinopathies HA injection is a treatment method that increases the ability of sliding with its viscoelastic properties, reduces tendon surface friction and accelerates regeneration. In vitro models suggest that HA can increase collagen I production and accumulation with a dose-dependent positive collagen I / collagen III ratio. However, controlled randomised studies are still needed. Mechanism of action of both PrT and HA is cell proliferation and the healing process of tendons, this study was conducted to compare the effect of PrT and HA in chronic lateral epicondylitis .

Conditions

• Lateral Epicondylitis
• Tennis Elbow

Interventions

Type	Name	Description
DRUG	Hyaluronic Acid	Patients were infiltrated with injection single dose 30 mg/2 ml 1500 kilodalton high molecular weight hyaluronic acid at the lateral epicondyle according to the standard technique.
BIOLOGICAL	Prolotherapy	Patients were infiltrated with 5cc of dextrose 15% at the lateral epicondyle according to the standard technique. For solution, 1 cc 2% lidocaine, 5 cc 30% hypertonic dextrose and 4 cc 0.9 % isotonic were used.

Timeline

• Start date: 2018-05-02
• Primary completion: 2018-09-15
• Completion: 2018-09-25
• First posted: 2020-05-20
• Last updated: 2020-05-20

Locations

1 site across 1 country: Turkey (Türkiye)