What side effects are associated with this type of intervention?

The most common treatments for osteoarthritis with anti-inflammatory effects, such as NSAIDs, can have several side effects. These include gastrointestinal issues like ulcers and bleeding, cardiovascular risks such as increased chances of myocardial infarction, and renal side effects including kidney damage. Topical NSAIDs may have fewer systemic side effects but can still cause local skin reactions. It is important to use the lowest effective dose for the shortest duration possible to minimize these risks.

What prior FDA approvals exist?

The FDA has approved several nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of osteoarthritis, including ibuprofen, naproxen, meloxicam, and diclofenac. These medications are commonly used due to their efficacy in reducing pain and inflammation associated with osteoarthritis. Additionally, selective COX-2 inhibitors like celecoxib have been approved for similar purposes. While these drugs are effective, they come with potential cardiovascular and gastrointestinal risks, which must be considered when prescribing them. Other treatments, such as duloxetine, have also been approved for patients who cannot tolerate NSAIDs or have not found relief with them.

What other types of research exist?

Promising novel alternatives to the Reparel™ knee sleeve for osteoarthritis patients include: 1) Ketoprofen in Transfersome® gel (IDEA-033), which has shown efficacy in reducing pain in knee OA patients. 2) Eltenac gel, a topical NSAID, which has demonstrated pain relief in clinical trials. 3) Gel-200, a cross-linked hyaluronate injection, which has been effective in reducing OA pain. 4) Diclofenac etalhyaluronate (DF-HA), a sustained-release formulation, which has shown promising results in pain reduction and improved mobility in knee OA patients.

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Anti-inflammatory Sleeve

Reparel™ Knee Sleeve for Osteoarthritis

N/A

Waitlist Available

Led By Amit Momaya, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

no corticosteroid knee injection for 90 days following consent

Be older than 18 years old

Must not have

prior surgery on the knee of interest

bilateral symptomatic knee osteoarthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special knee brace called the Reparel™ knee sleeve, which uses heat to help reduce pain and improve movement in people with knee pain. The study aims to see if this knee sleeve can help patients who have not found relief with other treatments or are not good candidates for surgery. The sleeve works by providing support and using warmth to ease pain and swelling. The Reparel™ knee sleeve is similar to other knee sleeves that have been studied for their ability to reduce pain and improve function in patients with knee pain.

Who is the study for?

This trial is for individuals with knee osteoarthritis confirmed by radiograph, who haven't had corticosteroid injections in the past 90 days and are choosing non-surgical treatments. It's not for those with prior knee surgery, both knees affected, unstable knees on exam, cancer in the knee area or hardware in the knee.

What is being tested?

The study tests if wearing a Reparel™ Knee Sleeve can improve mobility, function, and pain for people with knee osteoarthritis. The sleeve uses anti-inflammatory technology which might help manage symptoms of OA without drugs or surgery.

What are the potential side effects?

Since this intervention involves wearing a special sleeve and does not involve medication or invasive procedures, side effects may be minimal but could include skin irritation or discomfort at the site where the sleeve is worn.

Eligibility Criteria

Inclusion Criteria

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

Select...

I haven't had a corticosteroid injection in my knee for the last 90 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery on the knee we are discussing.

Select...

I have pain in both knees due to arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS-ADL)

Knee Injury and Osteoarthritis Outcome Score Pain (KOOS-P)

Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Reparel Sleeve GroupExperimental Treatment1 Intervention

Patients receiving reparel knee sleeve for treatment of knee osteoarthritis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Reparel Knee Sleeve

2021

N/A

~20

0 / 3Eligibility criteria met

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

The most common treatments for osteoarthritis (OA) primarily aim to reduce inflammation and alleviate pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which play a key role in the inflammatory process. This reduction in inflammation helps to decrease pain and improve joint function. Duloxetine, an antidepressant, is also used for its pain-relieving properties, likely due to its effect on neurotransmitters involved in pain perception. Intraarticular glucocorticoid injections provide short-term pain relief by directly reducing inflammation within the joint. These treatments are crucial for OA patients as they help manage symptoms, improve mobility, and enhance quality of life, although they come with potential side effects that need to be carefully managed.

Pathophysiology and first-line treatment of osteoarthritis.