Effect of Semiconductor Embedded Therapeutic Gloves for Hand Osteoarthritis

Effect of Semiconductor Embedded Therapeutic Gloves on the Mitigation of Hand Osteoarthritis: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

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

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Hand Osteoarthritis
• Intervention / Treatment: Device: Non-invasive circulation gloves; Device: Fabric gloves

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

    -

    Exclusion Criteria:

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Semiconductor circulation gloves; The gloves will have semiconductors embedded in the fabric.	Device: Non-invasive circulation gloves; Non-invasive class I medical device, circulation gloves with semiconductors embedded in the fabric.
Placebo Comparator: Placebo circulation gloves; The gloves will look identical to the active circulation gloves, but will not have semiconductors embedded into the fabric	Device: Fabric gloves; These gloves will look and feel identical to the active circulation gloves, but will not have semiconductors embedded in the fabric.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and weekly for 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, 3 months, 6 months, and 9 months
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.	Baseline and 9 months

Collaborators and Investigators

• Sponsor: Altoona Center for Clinical Research
• Collaborators: INCREDIWEAR HOLDINGS, INC.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): May 23, 2026
• Study Completion (Actual): May 23, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Semiconductor embedded fabric gloves for Hand Osteoarthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 2024-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Pre-approval to share data and data results must be obtained by the corporation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No