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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Drug: Botulinum toxin injection

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

subjects with chronic lateral epicondylitis already treated by physiotherapy, shock wave therapy, steroid injections without relief of pain

Description

Inclusion Criteria:

lateral epicondylitis at least one botulinum injection

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
epicondylitis with BTX 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.	Drug: Botulinum toxin injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain improvement	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	from enrollment to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	Any adverse event was notified	from enrollment to 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 29BRC24.0278 - EPITOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No