Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia

NCT05430893 | Completed

• 1 other identifier: APHP220617
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic athletic pubalgia is a frequent sport condition in which the effectiveness of medical treatment has not been proven. Intra-muscular injection of botulinum toxin A may have positive effects on pain in some chronic tendinitis. The investigators hypothesized that similar analgesic effect of intra-muscular botulinum toxin A may be observed in individuals with chronic AP. In the present study, the investigators aimed to describe the short-term evolution of pain and of activity limitations and quality of life, after an injection of the adductor longus with botulinum toxin A, in individuals with chronic AP, for whom medical and/or surgical treatments have failed.

Conditions

Athletic Pubalgia

Keywords

Chronic athletic pubalgia; Botulinum toxin; Groin pain; Adductor enthesopathy

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale

  Mean pain

  50 days

Secondary Outcomes (1)

• HAGOS score

  50 days

Study Arms (1)

Athletic pubalgia

Patients with chronic athletic pubalgia for whom medical and/or surgical treatments have failed and who were treated with an intra-muscular injection of botulinum toxin A injection under ultrasound guidance

Other: Botulinum Toxin A

Interventions

Botulinum Toxin A OTHER

100 UI IM in the adductor longus

Athletic pubalgia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic athletic pubalgia for whom medical and/or surgical treatments have failed and who were treated with an intra-muscular injection of botulinum toxin A injection under ultrasound guidance

You may qualify if:

• chronic AP
• symptom duration ≥ 3 months
• consistent clinical and magnetic resonance imaging findings according to the clinician
• failure of medical and/or surgical treatments with persistent pain and inability to return to play
• treatment with an intra-muscular injection of botulinum toxin A injection

You may not qualify if:

• age under 18 years
• ongoing pregnancy or breastfeeding
• treatments by anticoagulants
• muscular disorder (e.g. polymyositis, myopathy or other neuromuscular conditions)
• guardianship or curatorship
• individuals who had received botulinum toxin type A treatment for less than one year

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; 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 Officials

• Romain GAROFOLI

  Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

  PRINCIPAL INVESTIGATOR

• Marie-Martine Lefevre-Colau, MD, PhD

  Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: June 1, 2017
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)