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Hand Orthosis for Hand Osteoarthritis

N/A
Waitlist Available
Led By Grace H Lo, MD MSc
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 week follow up
Awards & highlights

Study Summary

This trial is testing two treatments for hand osteoarthritis at the Michael E. DeBakey VA Medical Center in Houston, Texas. The goal is to improve hand pain and limit damage from the arthritis.

Who is the study for?
This trial is for individuals with hand osteoarthritis who experience frequent pain in their fingers, have at least three affected joints, and are patients at the Michael E. DeBakey VA Medical Center in Houston, Texas. People planning or having had finger joint surgery, pregnant women, or those with inflammatory arthritis like gout or rheumatoid arthritis cannot participate.Check my eligibility
What is being tested?
The study tests two different treatments for hand osteoarthritis to see which one might better alleviate pain and prevent further damage. Participants will be randomly assigned to one of these treatments without choosing which one they receive.See study design
What are the potential side effects?
Since the intervention involves a hand orthosis (a type of brace), potential side effects may include discomfort from wearing the device, skin irritation under the brace, and possible restriction of movement leading to stiffness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 week follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 week follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary structure endpoint will be change in sum of the Kellgren and Lawrence score of all Distal InterPhalangeal Joints in the hand that was placed in an orthosis over 24 weeks.
Visual analog scale (VAS) for pain in the more symptomatic hand that includes the most symptomatic DIP joint by 24 weeks of use of traction therapy with standard of care treatment for hand OA to establish efficacy of traction therapy.
Secondary outcome measures
Functional Dexterity Test
Grip Strength
PinchStrength
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment arm with experimental orthosisExperimental Treatment1 Intervention
Group II: Treatment arm with control orthosisActive Control1 Intervention

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,907 Total Patients Enrolled
50 Trials studying Osteoarthritis
46,948 Patients Enrolled for Osteoarthritis
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,147 Total Patients Enrolled
3 Trials studying Osteoarthritis
414 Patients Enrolled for Osteoarthritis
Grace H Lo, MD MScPrincipal InvestigatorBaylor College of Medicine

Media Library

Hand orthosis Clinical Trial Eligibility Overview. Trial Name: NCT04784065 — N/A
Osteoarthritis Research Study Groups: Treatment arm with control orthosis, Treatment arm with experimental orthosis
Osteoarthritis Clinical Trial 2023: Hand orthosis Highlights & Side Effects. Trial Name: NCT04784065 — N/A
Hand orthosis 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784065 — N/A
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04784065 — N/A

Frequently Asked Questions

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

What is the projected participant count for this research endeavor?

"Affirmative. Clinicaltrials.gov divulges that this medical study has been recruiting since its posting on the 11th of February 2021 and is seeking out 40 volunteers from 1 centre."

Answered by AI

Are there any vacancies for participants in this experiment?

"The data on clinicaltrials.gov affirms that recruitment for the study is still ongoing; it was initially announced in November 2021, and its information updated just last month."

Answered by AI

What goals are researchers hoping to accomplish through this trial?

"This clinical trial's primary goal is to measure the efficacy of traction therapy combined with standard care for hand OA using a VAS test after 24 weeks. Secondary objectives include an assessment of pinch strength, grip strength, and joint tenderness on palpation."

Answered by AI

Who else is applying?

What state do they live in?
New York
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Michael E. DeBakey VA Medical Center
NYU Langone
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

Have severe pain and will try alternative treatments. My hand pain due to my Osteoarthritis causes me pain every day. It effects my daily life making it it difficult to do perform basic tasks.
PatientReceived 1 prior treatment
I’ve been trying to keep my pain under control for 13 years and have tried many different things that have not significantly improved the quality of my life. I’m pretty much willing to try anything. I am only 28 years old and want to live a better quality of life in the future.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Pilot Randomized Controlled Trial for Hand Osteoarthritis
Grace Hsiao-Wei Lo 2021. "A Pilot Randomized Controlled Trial for Hand Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04784065.
~0 spots leftby Apr 2024
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