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OpenTrials
Completed

NCT Number: NCT05430893

Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin A

Other

100 UI IM in the adductor longus

Primary outcomes

  1. Numerical rating scale

    Time frame: 50 days

    Mean pain

Secondary outcomes

  1. HAGOS score

    Time frame: 50 days

    Mean HAGOS total score

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: PUBATOX

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2022
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.