Efficacy of One or Two Botulinum Toxin Injections in the Treatment of Chronic Lateral Epicondylalgia: a Retrospective Study (EPITOX)

Active, not recruiting

• Conditions: Lateral Epicondylitis
• Interventions: Drug: Botulinum toxin injection

• Registration Number: NCT06765694
• Lead Sponsor: University Hospital, Brest

Brief Summary

Despite being a self-limiting injury, lateral epicondylitis (LE) can be difficult to manage. In cases of refractory LE, conservative treatment fails and symptoms persist over 6 months. Previous studies have investigated the role of botulinum Toxin Type A (BoNT-A) injections in LE with controversial results. There is some evidence that repeating the BoNT-A injection could be beneficial for refractory cases.

The objective is to assess the success rate of one or two BoNT-A injections for refractory LE.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-11-01
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

lateral epicondylitis at least one botulinum injection

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
epicondylitis with BTX injection	Botulinum toxin injection	Subjects included were addressed to a unique physician who performed all the treatment procedure with a diagnostic of lateral epicondylitis to receive a BTX injection.

Primary Outcome Measures

Name	Time	Method
pain improvement	from enrollment to 6 months	A qualitative scale was used to define the result of the treatment procedure based on pain improvement.; Poor : no improvement Temporary : significant but temporary pain reduction Partial : permanent but partial pain reduction Good : patient no longer requesting any treatment for LE due to pain relief

Secondary Outcome Measures

Name	Time	Method
adverse events	from enrollment to 6 months	Any adverse event was notified

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France