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

NCT04829565 | Active Not Recruiting Phase 4

• 1 other identifier: 19-AOI-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhizarthrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Dreiser test evaluation

  3 months after the injection

• adverse events

  through study completion, an average of 3 months

• Visual Analogue Scale at 8 weeks

  8 weeks after the injection

• intake of analgesic and anti-inflammatory drugs during the study period

  from the injection at Month 0 to the evaluation at Month 3, assessed up to 3 months

• sleep quality

  3 months after the injection

Study Arms (2)

botulinum toxin

EXPERIMENTAL

50 IU of botulinum toxin

Drug: Botulinum toxin

placebo

PLACEBO COMPARATOR

50 IU of placebo

Drug: Placebo

Interventions

Botulinum toxin DRUG

echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of botulinum toxin 50 IU

botulinum toxin

Placebo DRUG

echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of placebo

placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, PACA, 06000, France

Location

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

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 Officials

• Pierre Blanc

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 2, 2021
• Study Start: September 9, 2021
• Primary Completion: May 15, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

FR (1)