drugset / Trial / NCT03496649

Pubalgia and Adductor Tendinopathies Refractory to Medical Treatment

NCT03496649 ↗

Phase 2 Terminated 4 enrolled University Hospital, Bordeaux Ipsen · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-05-02
Primary completion
2021-01-01
Completion
2021-01-01

Outcome

Outcome not reported

Stopped (Business): “target number of patient not reached and lost of financial supplies”

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 200 iu Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 250 iu Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 300 iu Intramuscular

Indications