Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia (PUBATOX)

Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia: a Retrospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Athletic Pubalgia
• Intervention / Treatment: Other: Botulinum Toxin A

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75014
      • Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 100 UI IM in the adductor longus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale	Mean pain	50 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAGOS score	Mean HAGOS total score	50 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Romain GAROFOLI, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP); Study Director: Marie-Martine Lefevre-Colau, MD, PhD, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Groin pain; Botulinum toxin; Chronic athletic pubalgia; Adductor enthesopathy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: APHP220617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No