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NCT05990881 · ClinicalTrials.gov registry record · Phase 3
Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis
A Phase 3 study of Carpometacarpal Sprain and Thumb Sprain, sponsored by Rhode Island Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05990881: Recruiting Phase 3 study of Carpometacarpal Sprain and Thumb Sprain, sponsored by Rhode Island Hospital.
NCT05990881 is a Phase 3 study of Carpometacarpal Sprain and Thumb Sprain that is actively recruiting participants, run by Rhode Island Hospital. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05990881, a Phase 3 study of Carpometacarpal Sprain and Thumb Sprain, is actively recruiting participants, sponsored by Rhode Island Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this clinical trial is to gather information on the safety and effectiveness of botulinum toxin injection (or Botox) in the treatment of thumb joint pain/arthritis. People with thumb joint pain or arthritis usually receive steroid injections to help with the pain. However, this medicine does not always work well and also carries known important side effects. There is currently no alternative to this injection medicine. This clinical trial seeks to investigate botulinum toxin as a possible alternative to steroid injection. The difference between Botox and steroid injections is that they are different medicines and work in different ways. Botox, as it is being used in this study, is not FDA-approved. It is therefore considered an investigational medicine.
Primary Outcome
The primary outcome of interest is an improvement of thumb-specific pain scored by a change in the visual analog scale (VAS) pain score. VAS was chosen based on strong evidence supporting its validity in assessing pain in patients with OA. VAS will be measured by asking patients to make a vertical mark on a 10-cm horizontal line with 0 (far-left hash mark) representing no pain and 10 (far-right hash mark) representing the worst pain of their life. Scores will be quantified by measuring the diffe
Conditions Studied
Interventions
- DRUG Botulinum toxin
- DRUG Standard-of-care corticosteroid injections
Study Locations (1)
Rhode Island
- 235 Plain Street - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-08-27 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
What NCT05990881 shows while recruiting
NCT05990881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Carpometacarpal Sprain appearing as the primary indexed condition, and to 2 interventions - of which Botulinum toxin is the first listed.
NCT05990881 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05990881 about?
NCT05990881 is a clinical study titled "Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis". The purpose of this clinical trial is to gather information on the safety and effectiveness of botulinum toxin injection (or Botox) in the treatment of thumb joint pain/arthritis. People with thumb joint pain or arthritis usually receive steroid injections to help with the pain. However, this medici...
What is the current status of trial NCT05990881?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2023-08-27. Estimated completion is 2026-07.
What conditions does trial NCT05990881 study?
This clinical trial studies the following conditions: Carpometacarpal Sprain, Thumb Sprain, Clostridium; Botulinum.
What interventions are being tested in trial NCT05990881?
The interventions under investigation include: Botulinum toxin (DRUG), Standard-of-care corticosteroid injections (DRUG).
Who is sponsoring clinical trial NCT05990881?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05990881 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05990881's enrollment target sits among peer trials
50 1845th of 2000 higher than 141 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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