Pubalgia and Adductor Tendinopathies Refractory to Medical Treatment

NCT03496649 | Unknown Phase 2

• 1 other identifier: CHUBX2014/21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Groin Injury; Tendinopathy

Keywords

Primary Adductor tendinopathies; Pubalgia; Botulinum toxin type A

Outcome Measures

Primary Outcomes (1)

• 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.

  Between Day 80 and Day 90

Secondary Outcomes (11)

• Exercise-induced pain intensity (VAS)

  Daily between Day 0 and Day 90

• Pain relief

  On Day 30 and Day 90

• Goal Attainment Scaling (GAS)

  On Day 30 and Day 90

• Blazina clinical classification system

  On Day 30 and Day 90

• Adductor strength

  On Day 30 and Day 90

Study Arms (1)

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.

Drug: Dysport 500 Unit Powder for Injection

Interventions

Dysport 500 Unit Powder for Injection DRUG

Dysport administered by intramuscular injection

Dysport

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Anticoagulant treatment: heparin administered with an electrical syringe or AVK therapy with effective doses
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ipsen: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Interventions

Injections

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Mathieu De Seze, PH

CONTACT

0556795516; mathieu.de-seze@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: April 12, 2018
• Study Start: May 2, 2019
• Primary Completion: August 2, 2020
• Study Completion: August 2, 2020
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

FR (1)