Clinical trial NCT06902805: Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
Official title: Medium-and Long-term Efficacy of Two Ultrasound-guided Intra-articular Injections of onabotulinumtoxinA (Botox®) Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis : a Randomized Double-blind Controlled Trial in Three-parallel Arms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Base-of-thumb Osteoarthritis
Osteoarthritis
Keywords: base-of-thumb osteoarthritis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.

Detailed description: The base of the thumb is a frequent location of osteoarthritis. Base-of-thumb osteoarthritis affects middle-aged and older individuals and results in base-of-thumb pain and limitations in hand-specific activities. For the medium and long term, evidence suggests that splinting could reduce pain and improve hand function. For the short term, a combination of conservative treatments is recommended, with small-to-moderate treatment effect. However, use of intra-articular treatments (e.g., glucocorticoids and hyaluronan) for the short and medium term is currently debated. Use of intra-articular botulinum toxin A injection as a pain modulator in joint diseases has recently raised interest. Botulinum toxin A is a neurotoxin produced by Clostridium botulinum that inhibits acetylcholine release into the synaptic cleft in cholinergic nerve terminals. Additionally, treatment with botulinum toxin A showed intrinsic antinociceptive effects in various animal models of joint diseases.

In a pilot single-centred randomized controlled trial of 60 participants with painful base-of-thumb osteoarthritis, the investigators compared the effects of a single intra-articular injection of onabotulinumtoxinA (Botox® ) with those of a single intra-articular injection of normal saline on base-of-thumb pain, and found a significant reduction in pain.

Several perspectives raised from this pilot study. Like in the treatment of spasticity, repeated courses of intra-articular injections onabotulinumtoxinA may be necessary to obtain sustained analgesic effects over time. A replication of these findings in a multicentred setting, analysis of cost-effectiveness and description of safety at longer term are also needed before the official recommendation of this treatment. In RHIBOT II, the investigators hypothesize that 2 ultrasound-guided intra-articular injections of onabotulinumtoxinA, as an add-on therapy to custom-made rigid splinting, could reduce base-of-thumb pain at 6 months after the first injection.

Eligibility criteria: Inclusion Criteria:

* • Individuals aged at least 18 years;

  * Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);
  * Pain involving the base of the thumb;
  * X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;
  * 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.
  * Patient able to give written informed consent prior to participation in the study
  * Affiliation with a mode of social security (profit or being entitled).
  * Negative pregnancy test in women of childbearing potential

Exclusion Criteria:

* • Secondary osteoarthritis;

  * History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;
  * Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders;
  * Contra-indication to onabotulinumtoxinA;
  * Neurological disorders involving the hands other than carpal tunnel syndrome;
  * Collagen disorders involving the hands;
  * Osteoarthritis predominating at the scaphotrapezial joint on x-ray;
  * Bilateral trapezometacarpial osteoarthritis without a predominant painful side;
  * Hand or wrist trauma for up to 2 months;
  * Intra-articular treatments for up to 2 months;
  * Use of IM, IV or oral corticosteroids for up to 2 months.
  * Protected adults (including individual under guardianship by court order)
  * Pregnant women and lactation; lack of contraception for women of childbearing potential
  * Patient participating in another investigational therapeutic study
  * Patient unable to speak and read french

Primary outcomes:
measure: Base-of-thumb pain on a self-administered 11-point numeric rating scale
timeFrame: 6 months
Secondary outcomes:
measure: Base-of-thumb pain on a self-administered 11-point numeric rating scale
timeFrame: 1 and 12 months
measure: Hand-specific activity limitations on the self-administered Cochin Hand Function Scale
timeFrame: 6 and 12 months
measure: patient global assessment on a self-administered 11-point numeric rating scale
timeFrame: 6 and 12 months
measure: health-related quality of life on the self-administered EQ-5D-5L questionnaire
timeFrame: 6 and 12 months
measure: Osteoarthritis Research Society International-Outcome Measures in Rheumatology response
timeFrame: 6 and 12 months
measure: estimated total costs and incremental cost-utility ratio
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis du Pr François Rannou, Hôpital Cochin
state: Île-de-France
Study officials:
affiliation: Organizational Affiliation: Université Paris Cité, Faculté de Santé | UFR de Médecine
name: Christelle NGUYEN, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: