Pulsed ElectroMagnetic Field Therapy With Square Wave Forms and Artificial Intelligence Within the Software Interface for Individualised, Bespoke Bio-Electromagnetic Therapy to Treat Symptoms of Chronic Lyme Disease Remaining After Antibiotics Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Kasey Phifer
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Overall Energy Levels
研究概览
简要总结
Overview
PEMF Therapy for relief or reduction of lingering symptoms after antibiotic treatment of Lyme disease of participants in the UK.
Symptoms monitored:
Muscle ache, myalgia, muscle pain that is acutely located and/or 'wandering' (different location on different days) Aching joints Headache Fatigue, general tiredness, loss of energy, general exhaustion Mild, recurrent fever and/or chills occurring regularly Lack of oxygen in blood, feelings of 'air hunger', too high carbon dioxide levels in blood
详细描述
Hypothesis Period measured and observed: 18 months (Includes before treatment, during the 4-8 weeks of treatment and post treatment)
Control Group Control Group symptoms will remain the same or increase (deteriorate or worsen) by 10-20% over the period observed.
The Control Group is not asked to nor required to abstain from any other forms of treatment during the 10 month observational period; Persons in the Control Group are free to - but not encouraged to - pursue holistic, complementary and mainstream medicine for their symptoms related to contraction of Lyme Disease and any other illness that may arise.
In the event of receiving treatment or taking medicine, this information is to be passed along for data collection in the regular surveys. This will be taken into consideration when evaluating the results of the trial and hypothesis.
Test Group Test Group symptoms will improve (be reduced or eliminated) by 50-75% over the period observed; In particular, the largest improvement will be achieved during the 8 weeks of treatment. After treatment, there may be a slight improvement of symptoms, however, the improvement achieved during treatment is expected to remain the same over the next 7.5 months following treatment with the exception of re-infection or contraction of a different disease or illness.
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
- Single (Outcomes Assessor)
盲法说明
The independant analyst will assess the results provided in the survey, which are collected by a third party (the Google Forms app) and therefore cannot be tampered with by the Investigator. Participants complete surveys on their own mobile devices or computers at home, without any possible supervision or influence by the Investigator. The Participants are each assigned a code with which they complete the surveys on-line. The codes do not imply hierarchy (e.g. 'Alpha'), do not include numbers so as not to prime participants' answers, and have been carefully selected to remain neutral from gender, nationality, ethnicity or religious references.
Participants have been allocated randomly using a web-based random number generator. (Screenshots of results along with participants can be requested from the Investigator.)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis from GP confirming Lyme disease and/or
- •Blood test confirming Lyme disease and/or
- •Symptoms that correlate to Lyme disease without diagnosis from GP. This is called "self diagnosis" and because 80% of the trial is focused on treating symptoms and not the spirochetes, bacteria or small cysts of Lyme disease, the results are expected to be largely the same
排除标准
- •Persons currently undergoing antibiotic treatment for Lyme or other conditions
- •Persons who were prescribed antibiotics but did not or could not take them
结局指标
主要结局
Overall Energy Levels
时间窗: 18 months
This is inversely describing fatigue, chronic fatigue and exhaustion which is a common symptom of Lyme Disease.
Myalgia
时间窗: 18 months
This will be described to participants in an easy-to-understand 'layman' terminology. Words here include e.g. muscle ache, soreness of muscles.
Joint stiffness
时间窗: 18 months
Stiffness, soreness and lack of range of motion in any and all joints
Depression
时间窗: 18 months
This is measuring the participant's own subjective feelings of mood and depression, not a clinical diagnosis.
Fever/Chills
时间窗: 18 months
mild, recurrent fever is a common symptom of Lyme Disease. Temperature will be measured by the participants themselves should they suffer from this.
次要结局
- Ability to Breathe(18 months)
- Encephalitis(18 months)
- Brain Fog(18 months)
- Nerve pain / damage(18 months)
研究者
Kasey Phifer
CEO and Lead Practitioner
The National Centre for ElectroMagnetic Therapies CIC