Pubalgia and Adductor Tendinopathies Refractory to Medical Treatment

• Status: Unknown status
• Trial end date: 2020-08-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

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 breastfeeding woman

• Women of child-bearing potential not using contraceptive methods during the study duration