Pubalgia and Adductor Tendinopathies Refractory to Medical Treatment (NCT03496649) | Clinical Trial Compass
TerminatedPhase 2
Pubalgia and Adductor Tendinopathies Refractory to Medical Treatment
Stopped: target number of patient not reached and lost of financial supplies
France4 participantsStarted 2019-05-02
Plain-language 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.
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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) :
* 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 breas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with a pain reduction (VAS)