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

NCT06765694 | Active Not Recruiting

• 1 other identifier: 29BRC24.0278 - EPITOX
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• adverse events

  from enrollment to 6 months

Study Arms (1)

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

Interventions

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.

epicondylitis with BTX injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• lateral epicondylitis at least one botulinum injection

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 9, 2025
• Study Start: November 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 9, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)