RecruitingPhase 2

Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis

United States30 participantsStarted 2023-11-21

Plain-language summary

The goal of this study is to investigate if a timed release steroid injection may be beneficial in treating carpometacarpal (CMC) joint (thumb) osteoarthritis. The main questions to be answered are: 1. does the steroid injection substantially reduce pain in the thumb 2. does the steroid injection help to increase thumb function Participants will be asked to undergo a thumb CMC joint injection and to attend follow up visits to assess pain and thumb function.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female \> 18 years of age.
. X ray diagnosis of CMC osteoarthritis Eaton stages I, II or III.
. VAS pain score in affected thumb of 5 or greater.
. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
. Willing to abstain from use of the following protocol-restricted medications during the study to be kept in a log if non compliant.

Exclusion criteria

. Females who are pregnant or nursing or plan to become pregnant during the study; women who plan to conceive during the study; or unwilling to practice birth control during participation in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analog Pain Score

Timeframe: Day 1 of injection to six months post injection

Trial details

NCT IDNCT06237153

SponsorMarie Badalamente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Carpometacarpal (CMC) Osteoarthritis trials