Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis

NCT ID: NCT03726788

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2022-04-30

Brief 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To date, 2 published randomized controlled trials and one unpublished Phase Ib clinical trial have shown that botulinum toxin injected intraarticularly improves pain and functionality in gonarthrosis.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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Botulinum Toxin Type A 100U

one intra-articular injection in the painful knee 30 days after the inclusion visit

Group Type: EXPERIMENTAL

Botulinum Toxin Type A 100U

Intervention Type: DRUG

one intra-articular injection of 100 U of botulinum toxin type A, diluted in 2 ml of 0.9% SSI

Botulinum Toxin Type A 200U

one intra-articular injection in the painful knee 30 days after the inclusion visit

Group Type: EXPERIMENTAL

Botulinum Toxin Type A 200U

Intervention Type: DRUG

one intra-articular injection of 200 U of botulinum toxin type A, diluted in 4 ml of 0.9% SSI

Triamcinolone Hexacetonide 20 MG/ML

one intra-articular injection in the painful knee 30 days after the inclusion visit

Group Type: ACTIVE_COMPARATOR

Triamcinolone Hexacetonide Inj Susp 20 MG/ML

Intervention Type: DRUG

one intra-articular injection of 2 ml Triamcinolone Hexacetonide

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Triamcinolone Hexacetonide Inj Susp 20 MG/ML

one intra-articular injection of 2 ml Triamcinolone Hexacetonide

Intervention Type: DRUG

Other Intervention Names

Botox 100 UNT Injection; Botox 200 UNT Injection; HEXATRIONE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hichem Khenioui, MD

Role: PRINCIPAL_INVESTIGATOR

GHICL

Locations

Lille Catholic University

Lille, , France

Countries

France

Other Identifiers

RC-P0037

Identifier Type: -

Identifier Source: org_study_id