Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain Level measured by 11- Point Numeric Rating Scale (NRS)
研究概览
简要总结
This study will assess the efficacy and mechanisms behind Energy Medicine in reducing chronic knee pain within an outpatient setting. This study will investigate a form of Energy Medicine (EM) performed by a natural solo practitioner, using a standard number of three sessions, which will compare to both positive and negative control groups. The positive control group will receive acupuncture and the negative control group will receive a sham intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presence of knee pain lasting for at least six months
- •No radiation of knee pain
- •No acupuncture treatments in the previous six months
- •Failure to respond completely to the medications given by their orthopedic or pain management specialist
- •Knee pain on most days (4 out of 7 days of the week) with average self-reported severity of 4 or more out of 10 on a numeric rating scale (NRS)
- •Complaints of morning stiffness lasting less than 30 minutes
- •Not be in active physical therapy (PT) for the duration of the trial.
- •Adult patients ≥18 years of age
- •English speaking
排除标准
- •Any concurrent diagnosis of systemic disease
- •Other concurrent treatments such as massage, Acupcunture, PT or any kind of Energy Medicine
- •Bleeding disorder
- •Trypanophobia (fear of needles or injections).
- •Have medical condition that causes difficulty in saliva production/collection (i.e.: Sjogren's Syndrome)
结局指标
主要结局
Pain Level measured by 11- Point Numeric Rating Scale (NRS)
时间窗: 18 Months
11 point scale (0-10) asking patient leve of discomfort. A state of no pain is "0" and worst pain is "10"
Self Reported Physical Function measured y the Western Ontario and McMaster Universities Ostheoarthritic Index (WOMAC)
时间窗: 18 Months
self-administered questionnaire consisting of 24 items divided into 3 subscales:\[1\] * Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright * Stiffness (2 items): after first waking and later in the day * Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Pain Level measured by Visual Analog Scale (VAS)
时间窗: 18 Months
used for quantification of pain; psychometric response scales used to measure subjective characteristics or attitudes and have been used in the past for a multitude of disorders, as well as in market research and social science investigations, among others
次要结局
未报告次要终点