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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05430893
Recruitment Status : Completed
First Posted : June 24, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Athletic Pubalgia 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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia: a Retrospective Observational Study
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021


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




Primary Outcome Measures :
  1. Numerical rating scale [ Time Frame: 50 days ]
    Mean pain


Secondary Outcome Measures :
  1. HAGOS score [ Time Frame: 50 days ]
    Mean HAGOS total score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05430893


Locations
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France
Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital
Paris, Ile De France, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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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)
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05430893    
Other Study ID Numbers: APHP220617
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Chronic athletic pubalgia
Botulinum toxin
Groin pain
Adductor enthesopathy
Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents