The Immunomodulatory Effects of Frequency Specific Microcurrent In Obese Osteoarthritic Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Interleukin-6
研究概览
简要总结
It is hypothesized that application of frequency specific microcurrent can decrease inflammation in osteoarthritis patients resulting in decreased pain and potentially decrease disease progression. Participants will received the microcurrent treatment for one hour and a total of five blood draws to measure inflammatory markers. Participants will also complete a pre and post treatment pain questionnaire.
详细描述
After consent, the participant's height and weight will be measured and body mass index calculated using the Athena Health Patient Portal. Next, the participant will complete a pain questionnaire to capture their baseline level of pain as well as a sign a declaration stating that they have drank a quart of water in the past four hours. Then, the patient will have an intravenous port established in an antecubital vein.
The procedure that are being done for research purposed include five intravenous port blood draws and treatment with frequency specific microcurrent.
The patient will have an intravenous port established in an antecubital vein. A baseline 10 mL blood sample will be taken.
Randomization scheme is as follows - after the block size was determined, all possible balanced combinations of assignment within the block were calculated. Blocks were then randomly chosen to determine the patients' assignment into the groups.
An unblinded research coordinator with no other participation in the study will apply the randomization scheme (example included as attachment) to patients to receive either the active microcurrent treatment or a sham treatment. The active treatment includes turning on a Precision Distributing CustomCARE preprogrammed to produce 40 Hz on channel A and 97 Hz on channel B with 200 µamp alternating current polarity with a sharp square wave slope and placing it in an opaque bag so neither the participant or the study investigators know whether the device is on or off. The sham treatment involves not turning the device on and placing it in the same bag.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 29.9
- •18 years of age or older
- •active osteoarthritis diagnosis
排除标准
- •BMI < 30
- •have taken immune-enhancing dietary supplements or medications for inflammation in the past 10 days
- •have or are currently being treated for any physician-diagnosed immune-modulating disease or disorder other than inflammatory arthritis
- •received chemotherapy within the past year
- •have ever received an FSM treatment with the frequency pair 40 Hz/97 Hz
研究组 & 干预措施
FSM Treatment Group
Participants receiving the 40 hertz/97 hertz alternating sharp square wave 200 uamp microcurrent treatment (machine is turned on and placed in an opaque bag to cover the screen; the machine is silent and therefore will be indistinguishable form placebo)
干预措施: Frequency Specific Microcurrent (Device)
Placebo Group (Sham)
Participants receiving sham microcurrent treatment (machine is turned off and placed in an opaque bag to cover the screen)
干预措施: Sham microcurrent treatment (Device)
结局指标
主要结局
Interleukin-6
时间窗: Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention
Plasma concentration
次要结局
- General Pain(Baseline, and immediately after the intervention)
- Tumor Necrosis Factor Alpha(Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention)
研究者
Samuel Spaiser
Principal Investigator
Nova Southeastern University