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Corticosteroid

Corticosteroid Injection for Thumb Arthritis

Phase 4

Recruiting

Research Sponsored by Shoulder & Upper Extremity Research Group of Edmonton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Present clinical and radiographic signs of thumb CMC OA using the American College of Rheumatology (ACR) criteria for the classification of hand osteoarthritis.

Participants must be 40 years old or older at recruitment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 3 months, 6 months

Awards & highlights

Study Summary

This trial will compare the effects of a corticosteroid and local anesthetic injection to a placebo injection for treating thumb arthritis.

Who is the study for?

This trial is for individuals over 40 with thumb osteoarthritis, confirmed by clinical and radiographic signs. Candidates must understand English and be able to complete follow-ups. It's not suitable for those with psychiatric illness, inflammatory arthritis history, cognitive impairments, or who are pregnant/breastfeeding.Check my eligibility

What is being tested?

The study compares the effectiveness of a corticosteroid (Depo-Medrol) injection versus a saline (placebo) injection in treating thumb joint osteoarthritis over six months. Both treatments include a local anesthetic.See study design

What are the potential side effects?

Corticosteroid injections like Depo-Medrol may cause side effects such as pain at the injection site, increased blood sugar levels, temporary flare-up of joint pain, infection risk at the injection site, and potential weakening of nearby bones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My thumb joint pain is diagnosed as osteoarthritis by ACR criteria.

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I am 40 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pain with movement

Secondary outcome measures

Change in Brief Michigan Hand Outcomes Questionnaire

Change in Pinch Strength

Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Corticosteroid InjectionExperimental Treatment1 Intervention

Pre-filled opaque syringe containing 40 mg (1cc) of depo-medrol combined with 0.5 cc of 1% lidocaine (or 1cc saline + 0.5 cc 1% lidocaine) will be injected in the symptomatic CMC joint using fluoroscopic imaging to ensure injection into the joint. If both CMC joints are symptomatic, the most symptomatic joint will be injected. If both CMC joints are equally symptomatic, the dominant hand will be injected.

Group II: SalinePlacebo Group1 Intervention

Pre-filled opaque syringe containing 0.5 cc of 1% lidocaine (or 1cc saline + 0.5 cc 1% lidocaine) will be injected in the symptomatic CMC joint using ultrasound imaging to ensure accuracy of injected location. If both CMC joints are symptomatic, the most symptomatic joint will be injected. If both CMC joints are equally symptomatic, the dominant hand will be injected.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Depo-Medrol Injectable Product

2017

Completed Phase 3

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shoulder & Upper Extremity Research Group of EdmontonLead Sponsor

6 Previous Clinical Trials

612 Total Patients Enrolled

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,868 Total Patients Enrolled

9 Trials studying Osteoarthritis

692 Patients Enrolled for Osteoarthritis

Media Library

Depo-Medrol Injectable Product (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04177433 — Phase 4

Osteoarthritis Research Study Groups: Saline, Corticosteroid Injection

Osteoarthritis Clinical Trial 2023: Depo-Medrol Injectable Product Highlights & Side Effects. Trial Name: NCT04177433 — Phase 4

Depo-Medrol Injectable Product (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04177433 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being taken in for this clinical experiment?

"Affirmative. The information posted on clinicaltrials.gov demonstrates that this medical trial has resumed recruitment of participants, beginning with its initial posting on December 2nd 2020 and most recently updated on May 10th 2022. A total of 90 patients are needed from one location for the study to be successful."

Answered by AI

Has the FDA sanctioned Corticosteroid Injection as a viable treatment?

"Based on the criteria of a phase 4 trial, our team rated corticosteroid injection as having a score of 3 - indicating it has already been approved and there is ample data to support its safety."

Answered by AI

What investigations involving Corticosteroid Injection have been conducted previously?

"Currently, 150 studies are being conducted on the effectiveness of Corticosteroid Injection. Of those studies, 39 have reached Phase 3 and the majority (6845) are based in Houston, Texas."

Answered by AI

In what health conditions is Corticosteroid Injection typically employed?

"Corticosteroid Injection is an oft-used therapy for ophthalmia, sympathetic issues and can even be helpful in the management of scalp structure problems, temporal arteritis, and lupus erythematosus."

Answered by AI

How many participants is this clinical trial accommodating?

"Indeed, clinicaltrials.gov indicates that this medical trial is presently seeking participants who meet the criteria for inclusion. It was initially posted on December 2nd 2020 and its last update occurred May 10th 2022; it requires 90 volunteers across a single site to complete enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint

2020. "The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04177433.

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