Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia

NCT ID: NCT05430893

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2021-03-31

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.

Detailed Description

The investigators included consecutive individuals 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 under ultrasound guidance. Participants were assessed 50 days after injection for pain using a numerical rating scale (NRS) (0, no pain, and 100, maximal pain) and for activity limitations and quality of life using the Copenhagen Hip and Groin Outcome Score (HAGOS) (0, worse outcome, and 100, most favorable outcome). Participants were also asked to self-report adverse events.

Conditions

Athletic Pubalgia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Botulinum Toxin A

Intervention Type: OTHER

100 UI IM in the adductor longus

Interventions

Botulinum Toxin A

100 UI IM in the adductor longus

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romain GAROFOLI

Role: PRINCIPAL_INVESTIGATOR

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

Marie-Martine Lefevre-Colau, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

APHP220617

Identifier Type: -

Identifier Source: org_study_id