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

Overview

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

• Drug OnabotulinumtoxinA
  intra-articular injection
• Drug Normal saline (placebo)
  intra-articular injection

Primary outcome measures

• Base-of-thumb pain on a self-administered 11-point numeric rating scale [Time frame: 6 months]

Secondary outcome measures (6)

• Base-of-thumb pain on a self-administered 11-point numeric rating scale [Time frame: 1 and 12 months]
• Hand-specific activity limitations on the self-administered Cochin Hand Function Scale [Time frame: 6 and 12 months]
• patient global assessment on a self-administered 11-point numeric rating scale [Time frame: 6 and 12 months]
• health-related quality of life on the self-administered EQ-5D-5L questionnaire [Time frame: 6 and 12 months]
• Osteoarthritis Research Society International-Outcome Measures in Rheumatology response [Time frame: 6 and 12 months]
• estimated total costs and incremental cost-utility ratio [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

France · 1 center

• Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Ap — Paris

Identifiers

NCT: NCT06902805 · APHP230823

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗