The Effects of Energy Healing in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Neural connectivity
研究概览
简要总结
This study aims to study the clinical effects of Energy Healing using fMRI and determine its application to Fibromyalgia patients. We also want to find out how active Energy Healing compares to sham Energy Healing in terms of brain connectivity and pain interference scores.
详细描述
The primary objective is to investigate the effects of energy healing as compared to sham EH on brain connectivity of the insula/salience network, sensory motor network, and default mode network as primary outcomes using fcMRI.
The secondary objective is to evaluate the effectiveness of EH in reducing clinical pain severity and interference (secondary outcomes) and their relationship to brain connectivity (secondary outcomes) as compared to placebo/sham EH.
The exploratory objective is to understand the effects of EH versus sham EH on brain functional response to visual stimuli, insular glutamate, heart rate variability, mood, sleep, and fatigue symptoms in fibromyalgia patients (all exploratory outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 and under 75 years of age.
- •Fibromyalgia patients must meet the 2016 Fibromyalgia Diagnostic Criteria for the classification of FM.
- •Mean recalled pain over the last seven days (7-day recall) between 4-10 cm on Visual - - - - Analog Scale (VAS) for pain with no pain free days in the last 2 months and active pain in resting state lying on back.
- •No contraindications for MRI, such as metal in the body or electrical devices in the body.
- •Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.
- •Able to travel to the study site to receive MRI, EH, and sham EH sessions up to twice weekly.
- •Understanding and willing to complete all study procedures.
- •Capable of giving written informed consent.
- •Proficient ability to speak, read, and write in english.
排除标准
- •EH within the last 6-months.
- •Have received past treatment from Charlie Goldsmith or know of him or his work.
- •Contraindications to MRI and fcMRI methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material, claustrophobia, etc. [Note: a more formal description of contraindications for MRI is present -in our DSM Plan].
- •Presence of known past procedures, devices in the body, claustrophobia, or other contraindications for MRI
- •Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain.
- •Peripheral neuropathy that interferes with activities of daily living.
- •Routine daily use of narcotic analgesics or history of substance abuse.
- •Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine [Adderall®], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
- •Concurrent participation in other therapeutic trials.
- •Pregnant or nursing.
- •Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation).
- •Active substance abuse disorder in the past 24 months as determined by subject self-report.
- •Use of PRN over the counter (OTC) pain medications (NSAIDs, etc.) on day of MRI scan.
- •Use of PRN narcotic pain medication 48 hours prior to MRI scan.
- •Current active litigation for FM pain.
- •Any impairment, activity or situation that in the judgment of the Principal Investigator or other team member that would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.
结局指标
主要结局
Neural connectivity
时间窗: Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment
change in brain connectivity of the insula/salience network (SLN), sensory motor network (SMN), and default mode network (DMN) resulting from energy healing (EH) as compared to sham EH.
次要结局
- Pain severity(Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment)
- Effects of Energy Healing vs sham Energy Healing on brain functional response(Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment)
研究者
Richard Edmund Harris
Samueli Endowed Chair and Professor
University of California, Irvine