NCT02325063

Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia

Leukocyte and Platelet Rich Plasma Versus Type A Botulinum Toxin Versus Glucocorticoids for the Treatment of Lateral Epicondylalgia: a Randomized, Multicenter, Double-blind, Therapeutic Trial With Three Parallel Arms

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the evolution of pain profiles among patients suffering from lateral epicondyalgia (tennis elbow) following three types of treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid injection.

Detailed description

The secondary objectives are to compare the following among the three groups: A- The global efficacy of each treatment defined by a minimum reduction of 25% in average pain over the last 24 hours between 0 and 6 months. B- The evolution of average pain over the last 24 hours between 0 and each different time frame (3 weeks, 6 weeks, 3 months and 6 months). C- The evolution of maximum pain scores using nocturnal post-effort (Jamar grip test) visual analog scales (VAS) between day 0, 3 weeks, 6 weeks, 3 months and 6 months. D- The perception of change on the Patient's Global Impression of Change score (PGIC) at 3 and 6 months E- The evolution of PRTEE scores at 0, 3 and 6 months F- Adverse events at 3 weeks, 6 weeks, 3 months and 6 months. G - Quality of life and utility via the SF-12 at 3 and 6 months. H- The consumption of analgesics.

Conditions

• Epicondylitis, Lateral Humeral
• Tennis Elbow

Interventions

Type	Name	Description
DRUG	PRP-L Injection	Patients will be treated with an injection of leukocyte and platelet rich plasma.
DRUG	Botox injection	Patients will be treated with an injection of Type A Botulinum toxin.
DRUG	Corticoid injection	Patients will be treated with an injection of Corticoids.

Timeline

• Start date: 2015-12-17
• Primary completion: 2017-05-02
• Completion: 2017-05-02
• First posted: 2014-12-24
• Last updated: 2025-12-10

Locations

2 sites across 1 country: France