Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis

NCT02832713 | Unknown Phase 2

• 1 other identifier: 6122
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents 35% of cases. It is thought that more than 2.5 million people older than 65 years have knee osteoarthritis. Currently, osteoarthritis management is based on three major axes:

1. 1.Non-pharmacological means, such as patient education, loss of weight and physical activity
2. 2.General pharmacological treatments: mainly paracetamol and then schedule II and III painkillers as well as nonsteroidal anti-inflammatory agent.
3. 3.Intra-articular pharmacological treatments:
4. 4.Intra-articular injections of corticosteroids: they are recommended during hydarthrotic flare-ups
5. 5.Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the absence of intra-articular effusion. However, their efficacy is questioned by most experts in the case of symptomatic knee osteoarthrosis.
6. 6.Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing patients, who are sometimes frail, to several peri- and post-operative complications, the recovery rate (variable according to the prosthesis type and ranging from 5% to 25% at 9 years) in an ageing population justifies waiting as much as possible before surgery. Therefore, it is important to test new therapeutic options for symptomatic osteoarthrosis that will allow postponing the surgical treatment.
7. 7.The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative. BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the management of painful reactive periarticular muscle contractures. However, BoNT-A has also antalgic activity independently of the myorelaxant effect. This allows explaining in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with a significant antalgic effect only in the groups treated with BoNT-A. No study has compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA in knee osteoarthritis and this is the aim of this trial.

Conditions

Painful Unilateral Femorotibial Knee Osteoarthritis of Any Etiology

Keywords

Knee osteoarthritis; Intra-articular botulinum toxin; Hyaluronic acid; Pain; Function

Outcome Measures

Primary Outcomes (1)

• Evaluation of pain measured using the WOMAC pain sub-score

  Change from baseline WOMAC pain sub-score at 3 months

Secondary Outcomes (8)

• Evaluation of the antalgic effect of BoNT-A vs hyaluronic acid measured using a verbal rating scale (VRS)

  1 week after injection

• Evaluation of the patients' functional improvement based on the WOMAC score ("stiffness and function sub-score" and total score)

  Before injection, 1 month, 3 months and 6 months following injection

• Evaluation of the patients' functional improvement using the Timed Up-and-go Test

  Before injection, 1 month, 3 months and 6 months following injection

• Evaluation of the quality of life based on the SF-36 score

  Before injection, 1 month, 3 months and 6 months following injection

• Frequency, seriousness and severity of adverse event reactions

  during the 6 months following injection

Study Arms (2)

Intra-articular injection of botulinum toxin A

EXPERIMENTAL

Drug: Botulinum toxin A ( BoNT-A)

Intra-articular injection of hyaluronic acid

ACTIVE COMPARATOR

Device: Hyaluronic acid (HA)

Interventions

Botulinum toxin A ( BoNT-A) DRUG

Intra-articular injection of BoNT-A

Intra-articular injection of botulinum toxin A

Hyaluronic acid (HA) DEVICE

Intra-articular injection of Hyaluronic acid

Intra-articular injection of hyaluronic acid

Eligibility Criteria

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

You may qualify if:

• Painful, or predominantly unilateral painful, knee osteoarthritis of any etiology
• Knee without clinical signs of intra-articular effusion
• Kellgren score ≥ II on X-ray

You may not qualify if:

• Clinical:
• Inflammatory arthropathy,infectious, neoplastic within the past year
• Neuromuscular pathology
• Cardiorespiratory pathology or any other severe disease that interferes with the functional capacities
• Any decompensated or unstable chronic pathology
• Glomerular filtration rate (GFR)\<15 mL/min/1.73m²) within the past 6 months
• HBA1c in diabetic people \> 12% within the past 6 months
• BMI ≥ 35kg/m2
• Infection: joint, general, distant, cutaneous
• Foreign material in the knee to be treated: prosthesis, osteosynthesis material
• Severe coagulation problem: platelets \<100000/mm3 within the past 6 months
• Allergy to BoNT-A
• Allergy to HA
• Pregnant or breast-feeding women
• Treatment with aminoglycosides or direct oral anticoagulants

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: July 14, 2016
• Study Start: June 9, 2017
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)