Tendinopathy Clinical Trial
— PETRAOfficial 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.
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 2, 2020 |
Est. primary completion date | August 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Ipsen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Exercise-induced pain intensity (VAS) | Average intensity of exercise-induced pain evaluated daily by the patient on a VAS type numerical scale | Daily between Day 0 and Day 90 | |
Secondary | Pain relief | Percentage of patients with over 50% pain relief compared to baseline | On Day 30 and Day 90 | |
Secondary | Goal Attainment Scaling (GAS) | Percentage of patients with over 50% GAS objective reached | On Day 30 and Day 90 | |
Secondary | Blazina clinical classification system | Improvement of at least 1 point on the Blazina clinical classification system in 50% of patients | On Day 30 and Day 90 | |
Secondary | 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 | On Day 30 and Day 90 | |
Secondary | 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 | On Day 30 and Day 90 | |
Secondary | Cure rate based on physician's evaluation | Percentage of patients with over 50% cure rate based on the physicians' evaluation of the patients' improvement | On Day 30 and Day 90 | |
Secondary | Treatment | Percentage of patients not asking for further treatment | On Day 30 and Day 90 | |
Secondary | 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. | On Day 30 and Day 90 | |
Secondary | HAGOS self-reported questionnaire | Improvement on the 6 dimensions of the HAGOS self-reported questionnaire | On Day 30 and Day 90 | |
Secondary | Tolerance | Tolerance evaluation: description and frequency of adverse effects. | Day 1, Day 7, Day 14, Day 30, Day 90 |
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