Effect of Semiconductor Embedded Therapeutic Gloves for Hand Osteoarthritis

Altoona Center for Clinical Research

Status: Invitation-only

Conditions: Osteoarthritis; Hand Osteoarthritis

Treatments: Device: Fabric gloves; Device: Non-invasive circulation gloves

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT06744855

2024-24

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Semiconductor circulation gloves

Active Comparator group

Description:

The gloves will have semiconductors embedded in the fabric.

Treatment:

Device: Non-invasive circulation gloves

Placebo circulation gloves

Placebo Comparator group

Description:

The gloves will look identical to the active circulation gloves, but will not have semiconductors embedded into the fabric

Treatment:

Device: Fabric gloves