NCT03726788

Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lille Catholic University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Knee osteoarthritis is one of the most common causes of joint pain and functional disability in the general population. Intra-articular infiltrations of corticoids are indicated for painful crisis especially if accompanied of effusion. However, this effect lasts only 2 weeks. Given the lack of effective long-term medical-infiltrative treatment, we believe that botulinum toxin type A could be used by its direct action on mediators of neuro-gene inflammation at the joint level and its indirect medullary action by retrograde migration. To date, 2 published randomized controlled trials and one unpublished Phase Ib clinical trial have shown that botulinum toxin injected intraarticularly improves pain and functionality in gonarthrosis. Dynamic Contrast Enhancement (DCE) Magnetic Resonance Imaging (MRI) demonstrated the correlation between synovial inflammation and pain in gonarthrosis in a cohort of 454 subjects. It has also made it possible, via the monitoring of synovial inflammation, to demonstrate the efficacy of treatments in patients suffering from rheumatoid arthritis in the early phase, juvenile chronic arthritis or osteoarthritis. DCE MRI perfusion therefore appears here as the technique of choice to follow the evolution of synovial inflammation after botulinum toxin injection in patients with symptomatic gonarthrosis.

Conditions

• Joint Diseases
• Knee
• Therapeutics
• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A 100U	one intra-articular injection of 100 U of botulinum toxin type A, diluted in 2 ml of 0.9% SSI
DRUG	Botulinum Toxin Type A 200U	one intra-articular injection of 200 U of botulinum toxin type A, diluted in 4 ml of 0.9% SSI
DRUG	Triamcinolone Hexacetonide Inj Susp 20 MG/ML	one intra-articular injection of 2 ml Triamcinolone Hexacetonide

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-11-01
• Completion: 2022-04-01
• First posted: 2018-10-31
• Last updated: 2025-09-10

Locations

1 site across 1 country: France