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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia participants - Energy Healing Intervention | Experimental | Female Fibromyalgia patients ages 18-75 who meet inclusion/exclusion criteria as stated in the IRB approved study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Healing | Other | EH derives from the theory that by using the body's biological energy, there can be a therapeutic effect that guides the patient towards a homeostatic state. Preliminary data in chronic pain patients, suggests that EH, delivered by an experienced practitioner, is able to reduce self-reported pain symptoms within minutes. Effects lasting for weeks to months have also been anecdotally reported. For patients with pain, this can result in a reduction of symptoms. Participants will also be presented with sham EH as a control. |
| Measure | Description | Time Frame |
|---|---|---|
| Neural connectivity | 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. | Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity | changes in pain severity and interference and their relationships to brain connectivity. We will determine if EH is effective in reducing clinical pain severity and interference as compared to placebo/sham EH and assess changes in their relationships before and after EH/sham EH to changes in brain connectivity. | Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard E Harris, PhD | Contact | (949) 824-7000 | richareh@hs.uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard Harris, PhD | UCI SSIHI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Irvine | Recruiting | Irvine | California | 92617 | United States |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Effects of Energy Healing vs sham Energy Healing on brain functional response | As exploratory outcomes, we will also explore the effects of EH vs sham EH on brain functional response to visual stimuli, insular Glx, heart rate variability, mood, sleep, and fatigue symptoms in FM patients. | Pre screening, Baseline, Intervention, 3- and 6-month follow ups Post-treatment |
| D009422 |
| Nervous System Diseases |