Magnetic Resonance Imaging Clinical Trial
— TOXARTOfficial title:
Analysis of Antalgic Efficacy of an Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis by Perfusion MRI:a Superiority, Randomized, Controlled, Double Blind Study
We believe we can demonstrate a link between the analgesic action of intra-articular injection of botulinum toxin and synovial inflammation by Dynamic Contrast Enhancement (DCE) perfusion Magnetic Resonance Imaging (MRI).
Status | Not yet recruiting |
Enrollment | 105 |
Est. completion date | April 2022 |
Est. primary completion date | November 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Presenting gonarthrosis of degenerative origin, Kellgren/Lawrence Radiological Stage I to III, with a maturity of more than 18 months - With pain intensity greater than or equal to 50/100 on an VAS - In case of bilateral gonarthrosis, the VAS of the contralateral knee must be less than or equal to 30/100 - Presenting a failure of conventional per os treatments (non-steroidal anti-inflammatory drugs, analgesics) - Affiliated with a social security scheme - For women of childbearing age: - effective contraception for the duration of the study Exclusion Criteria: - Patient presenting at the time of the inclusion visit: an inflammatory attack, septic or inflammatory arthritis, a generalized infectious episode in progress - Local or regional local skin lesion - Need of an arthroplasty within the next 12 months - Having received corticosteroids or other molecules in intra-articular infiltration in the last 6 months - History of traumatic knee injury (bone injury in the past 24 months), bone, ligament or meniscal surgery in the past 24 months - History of disabling peripheral nerve injury - Severe bleeding disorders, anticoagulant treatment in progress or double antiplatelet aggregation - BMI > 35 kg/m2 - Coxarthrosis with projected knee pain - Pregnant or breastfeeding woman - Patient under guardianship and protection of justice - Allergy/contraindication to botulinum toxin type A, corticoids - Usual contraindication to MRI - Allergy to the contrast product |
Country | Name | City | State |
---|---|---|---|
France | Lille Catholic University | Lille |
Lead Sponsor | Collaborator |
---|---|
Lille Catholic University | Allergan |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assesment of vascularization by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) according to the % Area Under the Curve (AUC) of perfusion value | one month post-injection | ||
Secondary | Pain analysis by the visual analogue scale (VAS) | Evolution kinetics of daily pain collected during the first 3 months post-injection allowing to deduce the onset and duration of analgesic efficacy in number of days. The pain VAS is a continuous scale comprised of a horizontal line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "pain as bad as it could be" (score of 100 [100-mm scale]) | during the first 3 months after injection | |
Secondary | Joint amplitude measured by goniometry | To measure range of motion of the knee | at 1, 3, 6 month post-injection | |
Secondary | Western Ontario McMaster University Osteoarthritis (WOMAC) Index | An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability | at 1, 3, 6 month post-injection | |
Secondary | Two minutes walk | This test measure the distance walked in two minutes | at 1, 3, 6 month post-injection | |
Secondary | Frequency of consumption of analgesics | at 1, 3, 6 month post-injection | ||
Secondary | Amount of consumption of analgesics | at 1, 3, 6 month post-injection |
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