Clinical trial NCT06744855: Effect of Semiconductor Embedded Therapeutic Gloves for Hand Osteoarthritis
Official title: Effect of Semiconductor Embedded Therapeutic Gloves on the Mitigation of Hand Osteoarthritis: a Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hand Osteoarthritis
Osteoarthritis
Keywords: Semiconductor embedded fabric gloves for Hand Osteoarthritis
Lead sponsor: Altoona Center for Clinical Research
Sponsor class: NETWORK
Collaborators: name: INCREDIWEAR HOLDINGS, INC.
First posted: 2024-12-20
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate change in symptoms using semiconductor embedded gloves for hand osteoarthritis.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with erosive hand OA, non-erosive hand OA, or first carpometacarpal joint OA with a Kellgren- Lawrence grade \>1 as determined by radiographic assessments and the American College of Rheumatology (ACR) classification
2. Patients age 40-75
3. Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
4. Patients who are willing and able to sign corresponding research subject consent form.

Exclusion Criteria:

1. Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
2. Patient has had prior surgical treatment of the hands in the last 5 years or injection treatment in the last 6 months
3. Patient has secondary OA including causes such as gout, rheumatoid arthritis, psoriatic arthritis
4. Patient has used topical creams or gels for arthritic pain including nonsteroidal anti-inflammatory drugs, capsaicin, lidocaine, or counterirritants in the last 1 week
5. Patient has a history of carpal tunnel syndrome, cubital tunnel syndrome, or radial tunnel syndrome
6. Patient has a history of peripheral neuropathy
7. Patient has chronic pain conditions unrelated to hand condition
8. Patient has auto-immune or auto-inflammatory diseases
9. Patient has used tobacco within the last 90 days
10. Patient is not within the ages of 40-75
11. Patient has an active infection (local or systemic)
12. Patient is unwilling or unable to sign the corresponding research subject consent form
13. Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.

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    Exclusion Criteria:

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Primary outcomes:
measure: Change in pain as measured by the Visual Analog Scale (VAS)
timeFrame: Baseline and weekly for 9 months
Secondary outcomes:
measure: Change in patient hand function as determined by the Australian Canadian Osteoarthritis Hand Index (AUSCAN)
timeFrame: Baseline, 3 months, 6 months, and 9 months
measure: Change in patient hand function as determined by the Functional Index for Hand Osteoarthritis (FIHOA)
timeFrame: Baseline, 3 months, 6 months, and 9 months
measure: Change in patient grip strength
timeFrame: Baseline, 3 months, 6 months, and 9 months
measure: Radiographic changes as determined by hand x-rays.
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
Study officials:
References:
citation: Marino K, Lee R, Lee P. Effect of Germanium-Embedded Knee Sleeve on Osteoarthritis of the Knee. Orthop J Sports Med. 2019 Oct 25;7(10):2325967119879124. doi: 10.1177/2325967119879124. eCollection 2019 Oct.