Groin InjuryPhase 2PETRANCT03496649
Pubalgia and Adductor Tendinopathies Refractory to Medical Treatment
A Phase 2 study testing Dysport 500 Unit Powder for Injection in people with Groin Injury and Tendinopathy, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Pubalgia is a pain syndrome located in the groin area. This syndrome is mainly described in young male athletes and typically affect the superficial muscles defining the boundaries of the femoral triangle, i.e. gracilis, pectineus, adductor brevis and especially adductor longus, and less commonly the deep muscles. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Groin Injury, Tendinopathy
- What is being tested?
- Dysport 500 Unit Powder for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2019to 1 Jan 2021
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient 18 to 65 years old
- Patient with episode of adductor tendinopathy, refractory to appropriate medical treatment lasting 3 months
- Tendinopathy confirmed by clinical investigation, echography and MRI.
- Patient naïve to intramuscular botulinum toxin injections
- Patient able to self-evaluate pain on a VAS
- Intensity of exercise-induced pain > 5 on a VAS of 10
- Patient able to provide a signed informed consent freely for the study protocol and data collection
Who cannot join
- Subject participating or having participated in the last 3 months in another study which could interfere with the objective of the study
- Neuralgia
- Acute muscle injury
- Progressive disease at the time of inclusion
- Anticoagulant treatment: heparin administered with an electrical syringe or AVK therapy with effective doses
- Exclusion criteria related to Dysport injection (botulinum toxin type A) :
Show all 13Show fewer
- Known hypersensitivity to botulinum toxin type A or to any of the components in the formulation (20% human albumin solution, lactose monohydrate)
- Subject with a significant deficit of clinical or subclinical neuromuscular transmission (myasthenia or Lambert-Eaton syndrome)
- Treatment that directly or indirectly interferes with neuromuscular transmission (aminoglycosides, curare, anticholinesterase, aminoquinoline, cyclosporine, etc.)
- Previous surgery with curarisation less than a month ago
- History of neuromuscular disorders
- Pregnant or breastfeeding woman
- Women of child-bearing potential not using contraceptive methods during the study duration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasability Study on the Use of Botulinum Toxin A in Primary Adductor Tendinopathies Refractory to Medical Treatment
Pubalgia is a pain syndrome located in the groin area. This syndrome is mainly described in young male athletes and typically affect the superficial muscles defining the boundaries of the femoral triangle, i.e. gracilis, pectineus, adductor brevis and especially adductor longus, and less commonly the deep muscles.
Clinically, the pain is located in the inner aspect of the thigh, where the tendons attach onto the pubic symphysis. It is usually unilateral, and sometimes associated with neuropathic pain suggestive of obturator nerve irritation.
Read more
There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement.
The use of botulinum toxin type A could be an option in cases of treatment failure. However, a feasibility study must be performed beforehand, and if results are positive, a controlled study on a larger cohort could be conducted.
The major potential impact is a great effective pain relief for patients with neurological diseases.
Read the detailed description
The incidence of pubalgia in the literature varies, with large series reporting an incidence close to 5-10%, representing 15 to 18% of all injuries.
Recurrences are also common, affecting 30 to 35% of cases.
Once other differential diagnoses (such as spondylarthropathy, colorectal cancer, kidney disease…) have been ruled out, athletic pubalgia is typically divided into three main categories based on the site of the injury:
- Abdominal wall, the most common form, representing 38 to 50% of all cases;
- Pubic symphysis due to osteoarthropathy of the pubic bone caused by repetitive stress injury, accounting for 10 to 15% of all cases of pubalgia;
- Adductor tendons, on which this study focuses, representing 22 to 38% of all cases of pubalgia, caused by repetitive tractions on the tendon insertions.
There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement.
Neuromuscular reprogramming is then performed to stabilise the pelvis, followed by a progressive resumption of sporting activities, guided by the pain level.
Generally, 70 to 85% of patients are able to resume their sporting activities with this management protocol.
In 15 to 20% of cases of essential adductor tendinopathy, symptoms do not improve and the only currently validated solution is then a tenotomy, sometimes combined with partial tendon release in recurring cases.
Recent studies showed that the use of botulinum toxin type A (BTA) produces fairly positive results in chronic tendinopathies, such as epicondylitis. However, the efficacy of BTA injections in adductor tendinopathies has not been demonstrated consistently and a feasibility study must be conducted to address this question.
The hypothetical benefit of BTA in adductor tendinopathies is based on the toxin's known effects:
- a purely analgesic effect, which reduces pain in the injected area within a few days. This type of chronic tendinopathy does not involve inflammation. The pain in such cases is most likely due to the action of neurotransmitters such as substance P and calcitonin gene-related peptide (CGRP). As BTA is known to inhibit the secretion of these neurotransmitters, this mechanism could explain the toxin's specific analgesic effect.
- a muscle relaxant effect due to its action on the motor endplate, which reaches its maximum 6 weeks after the injection, and lasts 3 to 6 months.
The resulting muscle relaxation helps improve healing of the damaged tendon, and provides sustained analgesia.
A series including 39 cases showed that botulinum toxin is effective on hip adductor muscles following total hip arthroplasty, providing reduced muscle contracture and improved hip mobility without side effects.
The use of botulinum toxin type A could be an option in cases of treatment failure. However, a feasibility study must be performed beforehand, and if results are positive, a study on a larger cohort could be conducted.
- Conditions
- Groin Injury, Tendinopathy
- Being tested
- Dysport 500 Unit Powder for Injection
- Keywords
- Primary Adductor tendinopathies, Pubalgia, Botulinum toxin type A
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysport 500 Unit Powder for InjectionDrug
Dysport administered by intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Dysport | Experimental | Dysport administration by intramuscular injection Each patient will receive one dose of Dysport at Visit 1.
At least 2 of the 4 muscles below will be injected, depending on which muscles are affected:
250 IU for the gracilis muscle 200 IU for the pectineus muscle 300 IU for the adductor longus muscle 200 IU for the adductor brevis muscle
These injections will be uni or bilateral, it will depend on clinical diagnosis.
If necessary, the 4 muscles will be injected with a maximum of 1500U Dysport. The total dose cannot exceed 1500 units. Receives: Drug: Dysport 500 Unit Powder for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a pain reduction (VAS)
Proportion of patients with a pain reduction of over 50% compared to baseline, as shown by the average pain intensity measured between D80 and D90 on a Visual Analogic Scale (VAS) from 0 to 10 (0 = no pain; 10 = worst pain imaginable).
Pain intensity will be daily collected by the patient in his patient's diary.
Measured: Between Day 80 and Day 90
Secondary outcomes (11)
Exercise-induced pain intensity (VAS)
Average intensity of exercise-induced pain evaluated daily by the patient on a VAS type numerical scale
Measured: Daily between Day 0 and Day 90
Pain relief
Percentage of patients with over 50% pain relief compared to baseline
Measured: On Day 30 and Day 90
Goal Attainment Scaling (GAS)
Percentage of patients with over 50% GAS objective reached
Measured: On Day 30 and Day 90
Blazina clinical classification system
Improvement of at least 1 point on the Blazina clinical classification system in 50% of patients
Measured: On Day 30 and Day 90
Adductor strength
Preservation or improvement of adductor strength measured with a dynamometer and resumption of sport activity (Tegner activity level scale) in 50% of patients
Measured: On Day 30 and Day 90
Cure rate based on patients' self-evaluation
Percentage of patients with over 50% cure rate based on the patients' self-evaluation of the improvement of their condition
Measured: On Day 30 and Day 90
Cure rate based on physician's evaluation
Percentage of patients with over 50% cure rate based on the physicians' evaluation of the patients' improvement
Measured: On Day 30 and Day 90
Treatment
Percentage of patients not asking for further treatment
Measured: On Day 30 and Day 90
Pain diary
Determination of a break point on the pain intensity graph plotted by the physician, based on the pain diary completed by the patient.
Measured: On Day 30 and Day 90
HAGOS self-reported questionnaire
Improvement on the 6 dimensions of the HAGOS self-reported questionnaire
Measured: On Day 30 and Day 90
Tolerance
Tolerance evaluation: description and frequency of adverse effects.
Measured: Day 1, Day 7, Day 14, Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start2 May 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Why it stopped: target number of patient not reached and lost of financial supplies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Groin InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496649
- Sponsor's protocol ID
- CHUBX2014/21
- Acronym
- PETRA
- Status last verified
- May 2019
- First submitted
- 3 Aug 2017
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Any exploitation of the data by Ipsen or for another research will be submitted to the preliminary agreement of CHU de Bordeaux and, in case of agreement, of a negotiated contract between the parties.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasability Study on the Use of Botulinum Toxin A in Primary Adductor Tendinopathies Refractory to Medical Treatment
- ClinicalTrials.gov ID
- NCT03496649
- Acronym / sponsor ID
- PETRA / CHUBX2014/21
- Conditions
- Groin Injury, Tendinopathy
- Keywords
- Primary Adductor tendinopathies, Pubalgia, Botulinum toxin type A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of patient not reached and lost of financial supplies
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 2 May 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 12 Apr 2018 (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.
Pubalgia is a pain syndrome located in the groin area. This syndrome is mainly described in young male athletes and typically affect the superficial muscles defining the boundaries of the femoral triangle, i.e. gracilis, pectineus, adductor brevis and especially adductor longus, and less commonly the deep muscles.
Clinically, the pain is located in the inner aspect of the thigh, where the tendons attach onto the pubic symphysis. It is usually unilateral, and sometimes associated with neuropathic pain suggestive of obturator nerve irritation.
There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement.
The use of botulinum toxin type A could be an option in cases of treatment failure. However, a feasibility study must be performed beforehand, and if results are positive, a controlled study on a larger cohort could be conducted.
The major potential impact is a great effective pain relief for patients with neurological diseases.
Detailed description
The incidence of pubalgia in the literature varies, with large series reporting an incidence close to 5-10%, representing 15 to 18% of all injuries.
Recurrences are also common, affecting 30 to 35% of cases.
Once other differential diagnoses (such as spondylarthropathy, colorectal cancer, kidney disease…) have been ruled out, athletic pubalgia is typically divided into three main categories based on the site of the injury:
- Abdominal wall, the most common form, representing 38 to 50% of all cases;
- Pubic symphysis due to osteoarthropathy of the pubic bone caused by repetitive stress injury, accounting for 10 to 15% of all cases of pubalgia;
- Adductor tendons, on which this study focuses, representing 22 to 38% of all cases of pubalgia, caused by repetitive tractions on the tendon insertions.
There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement.
Neuromuscular reprogramming is then performed to stabilise the pelvis, followed by a progressive resumption of sporting activities, guided by the pain level.
Generally, 70 to 85% of patients are able to resume their sporting activities with this management protocol.
In 15 to 20% of cases of essential adductor tendinopathy, symptoms do not improve and the only currently validated solution is then a tenotomy, sometimes combined with partial tendon release in recurring cases.
Recent studies showed that the use of botulinum toxin type A (BTA) produces fairly positive results in chronic tendinopathies, such as epicondylitis. However, the efficacy of BTA injections in adductor tendinopathies has not been demonstrated consistently and a feasibility study must be conducted to address this question.
The hypothetical benefit of BTA in adductor tendinopathies is based on the toxin's known effects:
- a purely analgesic effect, which reduces pain in the injected area within a few days. This type of chronic tendinopathy does not involve inflammation. The pain in such cases is most likely due to the action of neurotransmitters such as substance P and calcitonin gene-related peptide (CGRP). As BTA is known to inhibit the secretion of these neurotransmitters, this mechanism could explain the toxin's specific analgesic effect.
- a muscle relaxant effect due to its action on the motor endplate, which reaches its maximum 6 weeks after the injection, and lasts 3 to 6 months.
The resulting muscle relaxation helps improve healing of the damaged tendon, and provides sustained analgesia.
A series including 39 cases showed that botulinum toxin is effective on hip adductor muscles following total hip arthroplasty, providing reduced muscle contracture and improved hip mobility without side effects.
The use of botulinum toxin type A could be an option in cases of treatment failure. However, a feasibility study must be performed beforehand, and if results are positive, a study on a larger cohort could be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysport | Experimental | Drug: Dysport 500 Unit Powder for InjectionDysport administration by intramuscular injection Each patient will receive one dose of Dysport at Visit 1. At least 2 of the 4 muscles below will be injected, depending on which muscles are affected: 250 IU for the gracilis muscle 200 IU for the pectineus muscle 300 IU for the adductor longus muscle 200 IU for the adductor brevis muscle These injections will be uni or bilateral, it will depend on clinical diagnosis. If necessary, the 4 muscles will be injected with a maximum of 1500U Dysport. The total dose cannot exceed 1500 units. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patient 18 to 65 years old
- Patient with episode of adductor tendinopathy, refractory to appropriate medical treatment lasting 3 months
- Tendinopathy confirmed by clinical investigation, echography and MRI.
- Patient naïve to intramuscular botulinum toxin injections
- Patient able to self-evaluate pain on a VAS
Key exclusion criteria (13 listed)
- Subject participating or having participated in the last 3 months in another study which could interfere with the objective of the study
- Neuralgia
- Acute muscle injury
- Progressive disease at the time of inclusion
- Anticoagulant treatment: heparin administered with an electrical syringe or AVK therapy with effective doses
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 |
|---|---|---|
| Dysport 500 Unit Powder for InjectionDysport administered by intramuscular injection | Drug | Dysport |
Primary outcome
Proportion of patients with a pain reduction (VAS)
Time frame: Between Day 80 and Day 90
Proportion of patients with a pain reduction of over 50% compared to baseline, as shown by the average pain intensity measured between D80 and D90 on a Visual Analogic Scale (VAS) from 0 to 10 (0 = no pain; 10 = worst pain imaginable). Pain intensity will be daily collected by the patient in his patient's diary.
11 secondary outcomes
Exercise-induced pain intensity (VAS)
Time frame: Daily between Day 0 and Day 90
Pain relief
Time frame: On Day 30 and Day 90
Goal Attainment Scaling (GAS)
Time frame: On Day 30 and Day 90
Blazina clinical classification system
Time frame: On Day 30 and Day 90
Adductor strength
Time frame: On Day 30 and Day 90
Cure rate based on patients' self-evaluation
Time frame: On Day 30 and Day 90
Cure rate based on physician's evaluation
Time frame: On Day 30 and Day 90
Treatment
Time frame: On Day 30 and Day 90
Pain diary
Time frame: On Day 30 and Day 90
HAGOS self-reported questionnaire
Time frame: On Day 30 and Day 90
Tolerance
Time frame: Day 1, Day 7, Day 14, Day 30, Day 90
Results and safety
The study was stopped early (reason given: target number of patient not reached and lost of financial supplies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided. Any exploitation of the data by Ipsen or for another research will be submitted to the preliminary agreement of CHU de Bordeaux and, in case of agreement, of a negotiated contract between the parties.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dysport 500 Unit Powder for Injection in people with Groin Injury and Tendinopathy, run by University Hospital, Bordeaux 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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 24 Jun 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: target number of patient not reached and lost of financial supplies). Results are not available in the source record.
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?
Proportion of patients with a pain reduction (VAS) (time frame: Between Day 80 and Day 90). 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 24 Jun 2026.