Skip to content

RHIBOT II - 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
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515028-35-00
Acronym
APHP230823
Enrollment
120
Registered
2025-01-24
Start date
2025-12-03
Completion date
Unknown
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults aged at least 18 years with painful base-of-thumb osteoarthritis

Brief summary

The primary efficacy end point will be mean change from baseline in base-of-thumb pain on the painful side (either left or right) in the 48h previous to the interview on a self-administered 11-point numeric rating scale at 6 months after the first intra-articular injection, analysed by intention to treat.

Interventions

DRUGpoudre pour solution injectable
DRUGSODIUM CHLORIDE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary efficacy end point will be mean change from baseline in base-of-thumb pain on the painful side (either left or right) in the 48h previous to the interview on a self-administered 11-point numeric rating scale at 6 months after the first intra-articular injection, analysed by intention to treat.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026