Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia

Completed

• Conditions: Athletic Pubalgia
• Interventions: Other: Botulinum Toxin A

• Registration Number: NCT05430893
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2022-06
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Athletic pubalgia	Botulinum Toxin A	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

Primary Outcome Measures

Name	Time	Method
Numerical rating scale	50 days	Mean pain

Secondary Outcome Measures

Name	Time	Method
HAGOS score	50 days	Mean HAGOS total score

Trial Locations

Locations (1)

Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital; 🇫🇷 Paris, Ile De France, France