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

Not Applicable

Completed

• Conditions: Epicondylitis, Lateral Humeral; Tennis Elbow
• Interventions: Drug: PRP-L Injection; Drug: Botox injection; Drug: Corticoid injection

• Registration Number: NCT02325063
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Study Timeline

• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Study Start: 2015-12-17
• Primary Completion: 2017-05-02
• Study Completion: 2017-05-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP-L Group	PRP-L Injection	Patients randomized to this group will be treated with an injection of Leukocyte and Platelet Rich Plasma (PRP-L). Intervention: PRP-L Injection
Botox Group	Botox injection	Patients randomized to this group will be treated with an injection of Type A Botulinum Toxin (Xeomin®, MERZ). Intervention: Botox injection
Corticoid Group	Corticoid injection	Patients randomized to this group will be treated with an injection of Corticoids. Intervention: Corticoid injection

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) for pain over the last 24 hours	6 months versus Baseline (day 0)	score varying from 0 to 10

Secondary Outcome Measures

Name	Time	Method
Visual analog scale for pain over the last 24 hours	3 months	score varying from 0 to 10

Trial Locations

Locations (2)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

CHRU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France