Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Marie Badalamente · Other
Who this trial is looking for
This trial is looking for adults with thumb joint pain from arthritis to see if a special steroid injection can help reduce pain and improve thumb function. Participants will receive an injection and return for follow-up visits to check on their progress.
Are You a Good Fit for This Trial?
Must not be takingOpioidsOver-the-counter pain medications
Rules you outRheumatoid arthritisSeptic arthritisGouty arthritisPsoriatic arthritisThumb joint effusionDeQuervain's diseaseTrigger thumb
You may be able to join if
I am over 18 years old
I have been diagnosed with CMC osteoarthritis
I have a pain score of 5 or greater in my thumb
I can provide written consent and follow study requirements
I am willing to stop taking certain pain medications during the study
You may not be able to join if
I am pregnant, nursing, or planning to become pregnant during the study
I have a condition that may make my participation unsafe
I am allergic to triamcinolone acetonide
I have stage IV CMC osteoarthritis
I have rheumatoid arthritis or other specified types of arthritis
I have received any injections in my affected thumb joint within the last 6 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female \> 18 years of age.
2. X ray diagnosis of CMC osteoarthritis Eaton stages I, II or III.
3. VAS pain score in affected thumb of 5 or greater.
4. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply wi…
Inclusion Criteria:
1. Male or female \> 18 years of age.
2. X ray diagnosis of CMC osteoarthritis Eaton stages I, II or III.
3. VAS pain score in affected thumb of 5 or greater.
4. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
5. 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:
1. 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.
2. 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.
3. Known or suspected hypersensitivity to TA-ER (or component of TA-ER), triamcinolone acetonide.
4. 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.
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