Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04829565

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Nice

Nice, PACA, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Botulinum toxin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Visual Analogue Scale at 3 months

    Time frame: 3 months after the injection

    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.

Secondary outcomes

  1. Dreiser test evaluation

    Time frame: 3 months after the injection

    Dreiser test evaluation (functional index evaluation) at 3 months

  2. adverse events

    Time frame: through study completion, an average of 3 months

    Collecting adverse events

  3. Visual Analogue Scale at 8 weeks

    Time frame: 8 weeks after the injection

    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.

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

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

    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

  5. sleep quality

    Time frame: 3 months after the injection

    sleep quality (Spiegel sleep questionnaire ) at 3 months

  6. quality of life evaluation

    Time frame: 3 months after the injection

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 2, 2021
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.