Effect of Semiconductor Embedded Therapeutic Gloves on the Mitigation of Hand Osteoarthritis: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in pain as measured by the Visual Analog Scale (VAS)
研究概览
简要总结
The goal of this study is to evaluate change in symptoms using semiconductor embedded gloves for hand osteoarthritis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
- •Exclusion Criteria:
研究组 & 干预措施
Semiconductor circulation gloves
The gloves will have semiconductors embedded in the fabric.
干预措施: Non-invasive circulation gloves (Device)
Placebo circulation gloves
The gloves will look identical to the active circulation gloves, but will not have semiconductors embedded into the fabric
干预措施: Fabric gloves (Device)
结局指标
主要结局
Change in pain as measured by the Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Change in patient hand function as determined by the Australian Canadian Osteoarthritis Hand Index (AUSCAN)(Baseline, 3 months, 6 months, and 9 months)
- Change in patient hand function as determined by the Functional Index for Hand Osteoarthritis (FIHOA)(Baseline, 3 months, 6 months, and 9 months)
- Change in patient grip strength(Baseline, 3 months, 6 months, and 9 months)
- Radiographic changes as determined by hand x-rays.(Baseline and 9 months)