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NCT Number: NCT06765694

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

lateral epicondylitis at least one botulinum injection

Exclusion criteria

  • none

Treatment and study plan

Botulinum toxin injection

Drug

first injection was done under ultrasound control in the extensor carpi radialis brevis (ECRB). The second one if necessary was subordinated to clinical examination and focused in one or more of the following: ECRB, extensor digitorum communis, supinator.

Primary outcomes

  1. pain improvement

    Time frame: 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 outcomes

  1. adverse events

    Time frame: from enrollment to 6 months

    Any adverse event was notified

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: EPITOX

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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