Base-of-thumb Osteoarthritis, Osteoarthritis
Conditions
Keywords
base-of-thumb osteoarthritis
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.
Interventions
DRUGOnabotulinumtoxinA
intra-articular injection
DRUGNormal saline (placebo)
intra-articular injection
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Base-of-thumb pain on a self-administered 11-point numeric rating scale | 6 months | French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Base-of-thumb pain on a self-administered 11-point numeric rating scale | 1 and 12 months | French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain) |
| Hand-specific activity limitations on the self-administered Cochin Hand Function Scale | 6 and 12 months | mean change from baseline in hand-specific activity limitations in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0: no limitations to 90: maximal limitations) at 6 and 12 months |
| patient global assessment on a self-administered 11-point numeric rating scale | 6 and 12 months | mean change from baseline in patient global assessment on a self-administered 11-point numeric rating scale (0: worst possible condition to 100: best possible condition) at 6 and 12 months |
| health-related quality of life on the self-administered EQ-5D-5L questionnaire | 6 and 12 months | mean change from baseline in health-related quality of life on the self-administered EQ-5D-5L questionnaire (0: death, 1: best quality of life) at 6 and 12 months |
| Osteoarthritis Research Society International-Outcome Measures in Rheumatology response | 6 and 12 months | Osteoarthritis Research Society International-Outcome Measures in Rheumatology response (Response / No response) |
| estimated total costs and incremental cost-utility ratio | 12 months | — |
Countries
France
Contacts
CONTACTChristelle NGUYEN, MD, PhD
CONTACTLaetitia PEAUDECERF, PhD
PRINCIPAL_INVESTIGATORChristelle NGUYEN, MD,PhD
Organizational Affiliation: Université Paris Cité, Faculté de Santé | UFR de Médecine
Outcome results
None listed