Hand orthosis for Arthrosis

1
Effectiveness
1
Safety
Michael E. DeBakey VA Medical Center, Houston, TX
Arthrosis+1 More
Hand orthosis - Device
Eligibility
Any Age
All Sexes
Eligible conditions
Arthrosis

Study Summary

A Pilot Randomized Controlled Trial for Hand Osteoarthritis

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Eligible Conditions

  • Arthrosis
  • Osteoarthritis
  • Osteoarthritis of the Hands

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Hand orthosis will improve 2 primary outcomes and 6 secondary outcomes in patients with Arthrosis. Measurement will happen over the course of 24 week follow up.

24 week follow up
Functional Dexterity Test
Grip Strength
PinchStrength
Tenderness on joint palpation
The Disabilities of Arm Shoulder and Hand (DASH)
The Functional Index for Hand Osteoarthritis (FIHOA)
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.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Treatment arm with control orthosis
Treatment arm with experimental orthosis

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Hand Orthosis is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Treatment arm with experimental orthosis
Device
Treatment arm with control orthosis
Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 week follow up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 week follow up for reporting.

Who is running the study

Principal Investigator
G. H. L.
Prof. Grace Hsiao-Wei Lo, Assistant Professor
Baylor College of Medicine

Closest Location

Michael E. DeBakey VA Medical Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Enrolled to receive medical care at the Michael E. DeBakey VA Medical Center
At least 3 joints affected by distal interphalangeal (DIP) nodal hand OA
DIP nodal hand OA will be defined as Heberden's nodes on physical exam.
Sufficiently severe frequent pain of at least one DIP
Frequent pain: pain on most days of the month for at least one month in the last year.
Minimum VAS pain severity of 40 on a 0 - 100 scale

Patient Q&A Section

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

Can arthrosis be cured?

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The majority of arthrosis cases are not treatable by means of surgical techniques at present. So, an accurate and complete assessment of all arthrosis cases seems warranted.

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What causes arthrosis?

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Arthritis is a multifaceted condition associated with a broad range of medical problems that lead to functional disability. The cause of arthritis remains elusive and requires further investigation.

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How many people get arthrosis a year in the United States?

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The [results highlight] the importance of using all available data to ensure accurate and complete estimates of prevalence. The high incidence of AR as reported in this study is probably a direct result of [USP's] use of [National Health Survey] methodology and data collection.

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What are the signs of arthrosis?

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A careful clinical history is not enough for differential diagnosis between arthritis related to osteoarthritis, rheumatoid arthritis and gout. The mainstay of diagnosis is supported by radiological findings of joint effusion and synovial thickening. The differential diagnosis also includes ankylosing spondylitis, psoriatic arthritis and enthesitis. Radiological criteria for this latter condition appear to be the most reliable method of differentiating from the other forms of arthritis.

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What is arthrosis?

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Arthrosis is commonly accompanied by a variety of other diseases such as osteoarthritis or osteoporosis. Treatment options include non-steroidal anti-inflammatory drugs, paracetamol (acetaminophen), and exercise therapy.

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What are common treatments for arthrosis?

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Arthrosis often requires surgery, which involves removing diseased cartilage from the joint. Sometimes, arthrosis progresses to osteoarthritis, which can occur for most joints. In the later states of osteoarthritis, joint replacement is often indicated, but it takes some years for the patient's joints to regain function using artificial joints.

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What does hand orthosis usually treat?

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Hand orthosis is used to improve hand performance, in particular the ability of the hand to perform functional tasks. Hand orthosis is usually used to treat specific hand dysfunction, including stiffness, poor finger range of motion and grip strength problems. Overall use of hand orthosis in the day-to-day life of people with arthritis is low. summary: This article discusses non-surgical methods of reducing and preventing wrist instability in arthritis.

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Is hand orthosis typically used in combination with any other treatments?

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A Cochrane review showed tentative evidence to indicate a clinical advantage to the use of orthoses during activity, but high-level evidence is lacking. The existing research indicates that hand orthoses may be beneficial in relieving pain caused by inflammation associated with rheumatoid arthritis and may reduce stiffness in people with osteoarthritis. Orthoses are typically used in combination with medical treatments such as the use of painkillers. The evidence suggests that the use of the hand orthoses may improve the outcome of these treatments; further research will be needed.

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Have there been other clinical trials involving hand orthosis?

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There are no other trials assessing the use of hand orthosis for hand OA. Clinicians must therefore be vigilant in applying the findings of these trials.

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What is the average age someone gets arthrosis?

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The average age of the time of diagnosis for arthrosis is 76 years old. Arthrosis was less frequently diagnosed in males than females. Additionally, the time of diagnosis for arthrosis increased with the number of surgeries and was slightly lower for smokers.

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How does hand orthosis work?

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Hand orthosis has a profound effect on static and dynamic hand function and pain. While a control was not used in this study, the results suggest that an orthosis may lead to over-correction. In a young population, this does not seem to be an issue.

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Does arthrosis run in families?

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The family history in this study is comparable to the 1.8% prevalence in population based studies and indicates that arthrosis has a genetic component. However, the mode of inheritance is unknown.

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