NCT06237153 · Marie Badalamente
Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Triamcinolone Acetonide extended release suspension
Active steroid
Primary outcome measures
Visual Analog Pain Score
Time frame: Day 1 of injection to six months post injection
PAIN
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Opioid or over the counter medications for pain for the study duration
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.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Known or suspected hypersensitivity to TA-ER (or component of TA-ER), triamcinolone acetonide.
- Stage IV CMC osteoarthritis is excluded. Rationale for exclusion of stage IV is that these patients are most likely surgical candidates due to severe joint damage. Other exclusion criteria include rheumatoid arthritis, septic or gouty arthritis or psoriatic arthritis, thumb joint effusion, DeQuervain's disease, trigger thumb or history of CMC joint surgical reconstruction, or terminal or chronic and serious, uncontrolled associated medical conditions. Patients who have received hyaluronan or platelet rich plasma (PRP) injections to the affected CMC joint within 6 months will be excluded. Patients who have received a steroid injection to the affected CMC joint within 3 months will be excluded.
Where
- Stony Brook, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 1, 2024 · Source of record for eligibility and locations