Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb

Only 4 randomized controlled clinical trials have been published to date to assess the short-term effectiveness of intra-articular Botulinum Toxin injection on pain, function and quality of life in patients suffering from chronic knee pain related or not to knee osteoarthritis and also in the context of ankle osteoarthritis. The analgesic properties and the reported safety make intra-articular Botulinum toxin a strong candidate in the treatment of symptomatic manifestations of osteoarthritis disease and more particularly in certain locations such as the trapezo-metacarpal joint. Investigators hypothesize that injection of intra-articular Botulinum toxin into the trapezo-metacarpal joint will be of benefit in reducing pain and improving function in patients with rhizarthrosis. Investigators will begin a monocentric randomized controlled trial comparing intra-articular injections of Botulinum toxin and placebo.

Study Overview

• Status: Recruiting
• Conditions: Rhizarthrosis
• Intervention / Treatment: Drug: Botulinum toxin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pierre Blanc; Phone Number: +33 0492039655; Email: blanc.p@chu-nice.fr
• Study Contact Backup: Name: Christian Roux; Phone Number: +33 0492035779; Email: roux.c@chu-nice.fr

Study Locations

• France
  • Paca
    • Nice, Paca, France, 06000
      • Recruiting
      • CHU de Nice
      • Contact: Pierre Blanc; Phone Number: +33 0492039655; Email: blanc.p@chu-nice.fr
      • Contact: Christian Roux; Phone Number: +33 0492035779; Email: roux.c@chu-nice.fr
      • Sub-Investigator: Stéphane Glenet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient >18 years old
• Patient with rhizarthrosis objectified by interrogation, radiography with at least 2 of the following criteria: osteophyte, joint space narrowing, subchondral sclerosis or geode
• Patient who has had an X-ray of the wrist (face, profile and Kapandji incidence) to estimate the severity of the rhizarthrosis.
• Patient with signed informed consent.
• Visual analog scale (VAS) of pain > 4
• Failure of well-conducted drug treatments with level 1 and 2 analgesics, anti-inflammatory drugs and orthotic devices
• Patients must have stopped all corticosteroid or non-steroidal anti-inflammatory drugs therapy within the last 48 hours.
• Patient affiliated with a Social Security plan
• Patient who can understand the study instructions
• Patient on effective contraception for more than one month according to the marketing authorization (Pill, intrauterine device, vaginal ring, contraceptive skin patch, hormonal subcutaneous implant)
• Infertile patients in connection with surgery (tubal ligation, oophorectomy, adnexectomy, hysterectomy)

Exclusion Criteria:

• History of surgery of the thumb column
• Patient who has received an intra-articular trapezoidal metacarpal injection of corticoids, botulinum toxin or hyaluronic acid or other product within the last 6 months.
• Patient who has received a Botulinum toxin injection at any site within the last 3 months
• Myasthenia or Lambert-Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe respiratory disorder or severe swallowing disorder
• Patients with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose)
• Patient with an infection or inflammation at the injection site concerned
• Pregnant or breastfeeding women (a urine pregnancy test will be performed)
• Patients with chronic inflammatory joint disease or microcrystalline pathology
• Current participation or less than 30 days of participation in a clinical drug trial
• Any medical or psychiatric condition that could prevent the proper understanding and conduct of the treatment and study (adult under guardianship)
• Patient who wishes to discontinue contraception during the study
• Patients at high risk of bleeding complications from the intra-articular injection (hemophilia, anticoagulant treatment, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: botulinum toxin; 50 IU of botulinum toxin	Drug: Botulinum toxin; echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of botulinum toxin 50 IU
Placebo Comparator: placebo; 50 IU of placebo	Drug: Placebo; echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale at 3 months	Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.	3 months after the injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dreiser test evaluation	Dreiser test evaluation (functional index evaluation) at 3 months	3 months after the injection
adverse events	Collecting adverse events	through study completion, an average of 3 months
Visual Analogue Scale at 8 weeks	Evaluation of pain by Visual Analogue Scale at 8 weeks. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.	8 weeks after the injection
intake of analgesic and anti-inflammatory drugs during the study period	Evaluate the intake of analgesic and anti-inflammatory drugs during the study period: collection of the consumption of analgesics and non-steroidal anti-inflammatory drugs in the patient's diary (international non-proprietary name, dosage, date and time) from the injection at Month 0 to the evaluation at Month 3	from the injection at Month 0 to the evaluation at Month 3, assessed up to 3 months
sleep quality	sleep quality (Spiegel sleep questionnaire ) at 3 months	3 months after the injection
quality of life evaluation	quality of life (SF-36 scale -) at 3 months. a score for each dimension of the SF-36 was calculated, ranging from 0 to 100. A low score reflects a perception of poor health, loss of function, and presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain	3 months after the injection

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Pierre Blanc, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 19-AOI-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No