Athletic PubalgiaPUBATOXNCT05430893
Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia
An observational study of Athletic Pubalgia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Athletic Pubalgia
- What is being tested?
- Botulinum Toxin A
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital
Paris, Île-de-France Region, 75014
About this study
Official title: 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.
Read the 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.
- Conditions
- Athletic Pubalgia
- Being tested
- Botulinum Toxin A
- Keywords
- Chronic athletic pubalgia, Botulinum toxin, Groin pain, Adductor enthesopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin AOther
100 UI IM in the adductor longus
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Botulinum Toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
Mean pain
Measured: 50 days
Secondary outcomes (1)
HAGOS score
Mean HAGOS total score
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jun 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic PubalgiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Romain GAROFOLI, Principal investigator, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)Marie-Martine Lefevre-Colau, MD, PhD, Study director, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430893
- Sponsor's protocol ID
- APHP220617
- Acronym
- PUBATOX
- Status last verified
- Sep 2025
- First submitted
- 20 Jun 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05430893
- Acronym / sponsor ID
- PUBATOX / APHP220617
- Conditions
- Athletic Pubalgia
- Keywords
- Chronic athletic pubalgia, Botulinum toxin, Groin pain, Adductor enthesopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletic pubalgia | – | Other: Botulinum Toxin APatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- age under 18 years
- ongoing pregnancy or breastfeeding
- treatments by anticoagulants
- muscular disorder (e.g. polymyositis, myopathy or other neuromuscular conditions)
- guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin A100 UI IM in the adductor longus | Other | Athletic pubalgia |
Primary outcome
Numerical rating scale
Time frame: 50 days
Mean pain
1 secondary outcome
HAGOS score
Time frame: 50 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain GAROFOLI principal investigator
Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
Marie-Martine Lefevre-Colau, MD, PhD study director
Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletic Pubalgia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (time frame: 50 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.