Hand OsteoarthritisNCT06744855
Effect of Semiconductor Embedded Therapeutic Gloves for Hand Osteoarthritis
A study testing Non-invasive circulation gloves and Fabric gloves in people with Hand Osteoarthritis and Osteoarthritis, run by Altoona Center for Clinical Research at 1 site in United States.
Trial summary
The goal of this study is to evaluate change in symptoms using semiconductor embedded gloves for hand osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hand Osteoarthritis, Osteoarthritis
- What is being tested?
- Non-invasive circulation gloves and Fabric gloves
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 23 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients age 40-75
- Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- Patients who are willing and able to sign corresponding research subject consent form.
Who cannot join
- Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- Patient has had prior surgical treatment of the hands in the last 5 years or injection treatment in the last 6 months
- Patient has secondary OA including causes such as gout, rheumatoid arthritis, psoriatic arthritis
- Patient has used topical creams or gels for arthritic pain including nonsteroidal anti-inflammatory drugs, capsaicin, lidocaine, or counterirritants in the last 1 week
- Patient has a history of carpal tunnel syndrome, cubital tunnel syndrome, or radial tunnel syndrome
- Patient has a history of peripheral neuropathy
Show all 15Show fewer
- Patient has chronic pain conditions unrelated to hand condition
- Patient has auto-immune or auto-inflammatory diseases
- Patient has used tobacco within the last 90 days
- Patient is not within the ages of 40-75
- Patient has an active infection (local or systemic)
- Patient is unwilling or unable to sign the corresponding research subject consent form
- 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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Trial locations and contacts
1 site in 1 country.
United States1 site
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
About this study
Official title: 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.
Read the 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.
- Conditions
- Hand Osteoarthritis, Osteoarthritis
- Being tested
- Non-invasive circulation gloves, Fabric gloves
- Keywords
- Semiconductor embedded fabric gloves for Hand Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive circulation glovesDevice
Non-invasive class I medical device, circulation gloves with semiconductors embedded in the fabric.
Fabric glovesDevice
These gloves will look and feel identical to the active circulation gloves, but will not have semiconductors embedded in the fabric.
| Study group | Role | What they receive |
|---|---|---|
| Semiconductor circulation gloves | Active comparator | The gloves will have semiconductors embedded in the fabric. Receives: Device: Non-invasive circulation gloves |
| Placebo circulation gloves | Placebo comparator | The gloves will look identical to the active circulation gloves, but will not have semiconductors embedded into the fabric Receives: Device: Fabric gloves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and weekly for 9 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025
- Primary completion23 May 2026
- Study completion23 May 2026
Why it stopped: Not enough patients interested at the site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altoona Center for Clinical Research
- Sponsor type
- Research network
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744855
- Sponsor's protocol ID
- 2024-24
- Status last verified
- May 2026
- First submitted
- 5 Nov 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Pre-approval to share data and data results must be obtained by the corporation.
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.
PubMed 31696136
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Semiconductor Embedded Therapeutic Gloves on the Mitigation of Hand Osteoarthritis: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06744855
- Acronym / sponsor ID
- 2024-24
- Conditions
- Hand Osteoarthritis, Osteoarthritis
- Keywords
- Semiconductor embedded fabric gloves for Hand Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients interested at the site
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Altoona Center for Clinical ResearchResearch network
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 23 May 2026 (actual)
- Study completion
- 23 May 2026 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semiconductor circulation gloves | Active comparator | Device: Non-invasive circulation glovesThe gloves will have semiconductors embedded in the fabric. |
| Placebo circulation gloves | Placebo comparator | Device: Fabric glovesThe gloves will look identical to the active circulation gloves, but will not have semiconductors embedded into the fabric |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Patients age 40-75
- Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- Patients who are willing and able to sign corresponding research subject consent form.
Key exclusion criteria (15 listed)
- Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- Patient has had prior surgical treatment of the hands in the last 5 years or injection treatment in the last 6 months
- Patient has secondary OA including causes such as gout, rheumatoid arthritis, psoriatic arthritis
- Patient has used topical creams or gels for arthritic pain including nonsteroidal anti-inflammatory drugs, capsaicin, lidocaine, or counterirritants in the last 1 week
- Patient has a history of carpal tunnel syndrome, cubital tunnel syndrome, or radial tunnel syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive circulation glovesNon-invasive class I medical device, circulation gloves with semiconductors embedded in the fabric. | Device | Semiconductor circulation gloves |
| Fabric glovesThese gloves will look and feel identical to the active circulation gloves, but will not have semiconductors embedded in the fabric. | Device | Placebo circulation gloves |
Primary outcome
Change in pain as measured by the Visual Analog Scale (VAS)
Time frame: Baseline and weekly for 9 months
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.
4 secondary outcomes
Change in patient hand function as determined by the Australian Canadian Osteoarthritis Hand Index (AUSCAN)
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)
Time frame: Baseline, 3 months, 6 months, and 9 months
Change in patient grip strength
Time frame: Baseline, 3 months, 6 months, and 9 months
Radiographic changes as determined by hand x-rays.
Time frame: Baseline and 9 months
Results and safety
The study was stopped early (reason given: Not enough patients interested at the site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Results publication: PubMed 31696136Marino 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.
- Individual participant dataSharing planned: Undecided. Pre-approval to share data and data results must be obtained by the corporation.
Related trials for Hand Osteoarthritis
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Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive circulation gloves and Fabric gloves in people with Hand Osteoarthritis and Osteoarthritis, run by Altoona Center for Clinical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough patients interested at the site). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain as measured by the Visual Analog Scale (VAS) (time frame: Baseline and weekly for 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06744855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.