Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT06902805
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RHIBOTII
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: