Clinical trial NCT05430893: Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia
Official title: Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletic Pubalgia
Keywords: Chronic athletic pubalgia
Botulinum toxin
Groin pain
Adductor enthesopathy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Numerical rating scale
timeFrame: 50 days
Secondary outcomes:
measure: HAGOS score
timeFrame: 50 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital
state: Ile De France
Study officials:
affiliation: Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
name: Romain GAROFOLI
role: PRINCIPAL_INVESTIGATOR
affiliation: Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
name: Marie-Martine Lefevre-Colau, MD, PhD
role: STUDY_DIRECTOR
References: