The goal of this study is to evaluate change in symptoms using semiconductor embedded gloves for hand osteoarthritis.
The semiconductor embedded fabric emits mid-level and far infrared waves and negative ions to the tissue which can increase circulation of both blood and lymph, plus facilitates the anti-inflammatory nitric oxide cascade by accelerating the binding of Calcium to Calmodulin. Nitric oxide down-regulates interleukin1 beta and inducible nitric oxide synthase in certain cell types, which leads to reduced cyclooxygenase-2 and prostaglandins-molecules responsible for causing inflammation and pain. Unlike other systemic COX-2 inhibitors such as nonsteroidal anti-inflammatory drugs (NSAIDs), targeted infrared and negative ion therapy stimulate localized reaction pathways, thereby reducing pain and inflammation. This study seeks to identify patient reported subjective and clinically measured objective outcomes for hand osteoarthritis pain management and hand function with application of semiconductor embedded fabric in the affected area.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
Non-invasive class I medical device, circulation gloves with semiconductors embedded in the fabric.
These gloves will look and feel identical to the active circulation gloves, but will not have semiconductors embedded in the fabric.
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Change in pain as measured by the Visual Analog Scale (VAS)
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The minimum number is zero meaning no pain and maximum number is 10 meaning the most pain the patient has every felt in their entire life. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain.
Time frame: Baseline and weekly for 9 months
Change in patient hand function as determined by the Australian Canadian Osteoarthritis Hand Index (AUSCAN)
The Australian/Canadian Osteoarthritis Hand Index (AUSCAN) is a self-administered questionnaire that assesses hand pain, stiffness, and function in patients with osteoarthritis. It is on a 5-point Likert scale, with pain severity questions and answer ranges from strongly disagree to strongly agree.
Time frame: Baseline, 3 months, 6 months, and 9 months
Change in patient hand function as determined by the Functional Index for Hand Osteoarthritis (FIHOA)
The Functional Index for Hand Osteoarthritis (FIHOA) is a self-administered patient specific questionnaire to assess the patient's function with hand osteoarthritis. It has 10 questions and is on a 4-point Likert scale with 0 = possible without difficulty • 1 = possible with slight difficulty • 2 = possible with important difficulty • 3 = impossible.
Time frame: Baseline, 3 months, 6 months, and 9 months
Change in patient grip strength
Patient's grip strength will be assessed with a hand dynamometer. The patient will squeeze the device with the patient's elbow at 90 degrees of flexion and wrist in 30 degrees of extension. A force output value in pounds (lbs) will be displayed and a higher number of force output indicates a stronger grip strength.
Time frame: Baseline, 3 months, 6 months, and 9 months
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Radiographic changes as determined by hand x-rays.
Change of the arthritic hand joint health such as reduction in osteophyte formation, presence of erosions, and joint space narrowing as measured by radiographic assessments compared to pre-treatment scans. The PI will determine if the arthritic hand has improved, stabilized, or worsened during the intervention.
Time frame: Baseline and 9 months