What side effects are associated with this type of intervention?

NSAIDs, commonly used to treat osteoarthritis, can cause gastrointestinal issues such as ulcers and bleeding, renal impairment, and an increased risk of cardiovascular events like myocardial infarction. Corticosteroid injections, another common treatment, can lead to joint infection, post-injection flare, and potential cartilage damage with repeated use. Both treatments provide symptomatic relief but do not halt the progression of joint damage.

What prior FDA approvals exist?

Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injections are commonly used treatments for osteoarthritis that have received FDA approval. NSAIDs, such as ibuprofen and naproxen, work by inhibiting cyclooxygenase (COX) enzymes, which reduces inflammation and pain. These drugs are widely used due to their effectiveness in managing osteoarthritis symptoms. Corticosteroid injections, like triamcinolone, reduce inflammation by suppressing the immune response and are typically used for short-term relief in patients with moderate to severe pain who have not responded to other treatments. Both treatment options are integral in managing osteoarthritis, providing symptomatic relief and improving patient quality of life.

What other types of research exist?

Promising novel alternatives to NSAIDs and corticosteroid injections for osteoarthritis patients include: 1) Protease inhibitors like tranexamic acid, which have shown significant anti-osteoarthritic activity. 2) Tissue gene therapy, such as TissueGene-C, which has demonstrated improvements in pain and function. 3) Sprifermin, which has been associated with increased cartilage thickness, although its clinical relevance requires further study. These treatments target different aspects of OA pathogenesis and may offer new therapeutic options.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 week follow up

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

NSAIDs work by inhibiting cyclooxygenase (COX) enzymes, which are involved in the production of prostaglandins that cause inflammation and pain. By reducing prostaglandins, NSAIDs help alleviate pain and decrease inflammation in osteoarthritis (OA) patients. Corticosteroid injections reduce inflammation by suppressing the immune response, inhibiting multiple inflammatory pathways, and thereby decreasing swelling and pain in the affected joints. Understanding these mechanisms is crucial for OA patients as it helps them and their healthcare providers make informed decisions about managing symptoms and improving quality of life.

Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: a systematic review and network meta-analysis.Pathophysiology and first-line treatment of osteoarthritis.

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

485 Previous Clinical Trials

1,086,876 Total Patients Enrolled

51 Trials studying Osteoarthritis

47,003 Patients Enrolled for Osteoarthritis

Baylor College of MedicineLead Sponsor

1,002 Previous Clinical Trials

6,002,751 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

~8 spots leftby May 2025

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