Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.

NCT ID: NCT06902805

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2028-05-31

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.

Conditions

Base-of-thumb Osteoarthritis; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

2 intra-articular injections of onabotulinumtoxinA

Group Type: EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type: DRUG

intra-articular injection

1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline

Group Type: EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type: DRUG

intra-articular injection

Normal saline (placebo)

Intervention Type: DRUG

intra-articular injection

2 intra-articular injections of normal saline

Group Type: PLACEBO_COMPARATOR

Normal saline (placebo)

Intervention Type: DRUG

intra-articular injection

Interventions

OnabotulinumtoxinA

intra-articular injection

Intervention Type: DRUG

Normal saline (placebo)

intra-articular injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christelle NGUYEN, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Organizational Affiliation: Université Paris Cité, Faculté de Santé | UFR de Médecine

Locations

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

Paris, Île-de-France Region, France

Countries

France

Central Contacts

Christelle NGUYEN, MD, PhD

Role: CONTACT

christelle.nguyen2@aphp.fr

01 58 41 29 45 ext. +33

Laetitia PEAUDECERF, PhD

Role: CONTACT

laetitia.peaudecerf@aphp.fr

01 58 41 12 13 ext. +33

Facility Contacts

Christelle Nguyen, MD, PhD

Role: primary

christelle.nguyen2@aphp.fr

01 58 41 29 45 ext. +33

Other Identifiers

APHP230823

Identifier Type: -

Identifier Source: org_study_id