Name: लेखक स्पॉटलाइट: क्रोनिक दर्द प्रबंधन अनुसंधान के तरीके और प्रगति
Uploaded: 2024-01-05T14:00:00
Description: Read this Scientific Article Protocol about Author Spotlight: Towards Biomarker Development Using Neuroimaging as a Tool to Enhance the Understanding of the Neural Basis of Pain at JoVE.com

लेखक काम में उनके इनपुट के लिए डॉ ब्रूस क्रॉसन और डॉ लिसा कृष्णमूर्ति सहित सेंटर फॉर विजुअल एंड न्यूरोकॉग्निटिव रिहैबिलिटेशन में जांचकर्ताओं के समर्थन को स्वीकार करना चाहते हैं। लेखक फिल्मांकन प्रक्रिया में उनकी अमूल्य मदद के लिए ग्रेस इंगम को भी धन्यवाद देते हैं। इस काम को यूनाइटेड स्टेट्स डिपार्टमेंट ऑफ वेटरन्स अफेयर्स रिहैबिलिटेशन रिसर्च एंड डेवलपमेंट सर्विस करियर डेवलपमेंट अवार्ड IK2 RX003227 (अन्ना वुडबरी) और सेंटर ग्रांट 5I50RX002358 द्वारा समर्थित किया गया था। अध्ययन डिजाइन, डेटा संग्रह, प्रबंधन, विश्लेषण, व्याख्या या रिपोर्टिंग में फंडर की कोई भूमिका नहीं है।

अध्ययन एमोरी विश्वविद्यालय (आईआरबी 112768) और अटलांटा वीए संस्थागत समीक्षा बोर्डों (1585632-2; आंतरिक संदर्भ संख्या: 003) के साथ-साथ अटलांटा वीए आर एंड डी समिति (बोर्ड संदर्भ संख्या: 3881)। सभी विषयों ने इस अध्ययन में भ?...

फाइब्रोमायल्गिया में कपाल विद्युत उत्तेजना की प्रभावकारिता का आकलन

वर्तमान अध्ययन के तरीके न केवल फाइब्रोमायल्गिया के लिए एक अत्यधिक प्रभावी उपचार पद्धति की संभावना प्रदान करते हैं, बल्कि इसके दर्द लक्षण प्रोफाइल के पहले उदाहरण से फाइब्रोमायल्गिया की नैदानिक प्रक?...

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>3T Siemens MAGNETOM Prisma Scanner</td>
			<td>Siemens Healthineers</td>
			<td>N/A</td>
			<td>From Emory&#39;s website: &#34;The Siemens Magnetom Prisma 3T whole-body MR system is equipped with: a state-of-the art gradient system with a maximum (per axis) strength of 80 mT/m and slew rate of 200 T/m/sec 
			64 independent RF receiver channels capable of 204 receiver connections 
			a 2-channel RF transmitter. Multiple coils are available, including: a 64-channel head/neck coil with 52 channels for imaging of the head region 
			a 32-channel head-only coil 
			a 20-channel head/neck coil with 16 channels for head 
			spine array coil 
			flexible chest coil 
			large and small flexible coil for extremity imaging.</td>
		</tr>
		<tr>
			<td>Alpha-Stim AID Kit</td>
			<td>Electromedical Products International Inc.</td>
			<td>SKU: 500KIT</td>
			<td>A total of 50 devices ordered for research purposes. 
			From the site: &#34;A prescription or order from a licensed healthcare professional is required to purchase this device (within the USA). FDA cleared for anxiety, insomnia and pain only, with approval for depression outside of the United States.&#34;</td>
		</tr>
		<tr>
			<td>CONN Toolbox v21a16 (RRID:SCR_009550)&#160;</td>
			<td>Whitfield-Gabrieli and Nieto-Castanon</td>
			<td>Version v21a16 (RRID:SCR_009550)</td>
			<td>CONN is an open-source SPM-based cross-platform software for the computation, display, and analysis of functional connectivity Magnetic Resonance Imaging (fcMRI). CONN is used to analyze resting state data (rsfMRI) as well as task-related designs.&#160;</td>
		</tr>
		<tr>
			<td>DSI Studio&#160;(RRID:SCR_009557)&#160;</td>
			<td>Fang-Cheng (Frank) Yeh</td>
			<td>RRID:SCR_009557</td>
			<td>DSI Studio is a tractography software tool that maps brain connections and correlates findings with neuropsychological disorders. It is a collective implementation of several diffusion MRI methods, including diffusion tensor imaging (DTI), generalized q-sampling imaging (GQI), q-space diffeomorphic reconstruction (QSDR), diffusion MRI connectometry, and generalized deterministic fiber tracking.</td>
		</tr>
		<tr>
			<td>fMRIPrep 20.2.5 (RRID:SCR_016216)&#160;</td>
			<td>NiPreps (NeuroImaging PREProcessing tools)</td>
			<td>Version 20.2.5. (RRID:SCR_016216)</td>
			<td>A functional magnetic resonance imaging (fMRI) data preprocessing pipeline that is designed to provide an easily accessible, state-of-the-art interface that is robust to variations in scan acquisition protocols and that requires minimal user input, while providing easily interpretable and comprehensive error and output reporting. It performs basic processing steps (coregistration, normalization, unwarping, noise component extraction, segmentation, skull-stripping, etc.) providing outputs that can be easily submitted to a variety of group level analyses, including task-based or resting-state fMRI, graph theory measures, and surface or volume-based statistics.</td>
		</tr>
		<tr>
			<td>MRIQC&#160;</td>
			<td>NiPreps (NeuroImaging PREProcessing tools)</td>
			<td></td>
			<td>MRIQC extracts no-reference IQMs (image quality metrics) from structural (T1w and T2w) and functional MRI (magnetic resonance imaging) data. (not directly used for analyses)</td>
		</tr>
		<tr>
			<td>Sammons Preston Jamar Hydraulic Hand Dynamometer</td>
			<td>Alpha Med Inc.</td>
			<td>SKU SAMP5030J1</td>
			<td>From the website: Ideal for routine screening of grip strength and initial and ongoing evaluation of clients with hand trauma and dysfunction. 
			Unit comes with carrying/storage case, certificate of calibration and complete instructions. Warranted for one full year. The warranty does not cover calibration. Latex free.</td>
		</tr>
		<tr>
			<td>SPRI 5-Pound Vinyl-Coated Weight</td>
			<td>SPRI | Amazon</td>
			<td>N/A</td>
			<td>Color: (E) Dark Blue | 5-Pound. Appears on Amazon: Dumbbells Hand Weights Set of 2 - Vinyl Coated Exercise &#38; Fitness Dumbbell for Home Gym Equipment Workouts Strength Training Free Weights for Women, Men (1-10 Pound, 12, 15, 18, 20 lb), https://www.amazon.com/stores/SPRI/Weights/page/9D10835A-CFAB-4DA1-BEE9-AE993C6B5BC1</td>
		</tr>
		<tr>
			<td>SPRI 8-Pound Vinyl-Coated Weight</td>
			<td>SPRI | Amazon</td>
			<td>N/A</td>
			<td>Color: (H) Black |8-Pound. Appears on Amazon: Dumbbells Hand Weights Set of 2 - Vinyl Coated Exercise &#38; Fitness Dumbbell for Home Gym Equipment Workouts Strength Training Free Weights for Women, Men (1-10 Pound, 12, 15, 18, 20 lb), https://www.amazon.com/stores/SPRI/Weights/page/9D10835A-CFAB-4DA1-BEE9-AE993C6B5BC1</td>
		</tr>
	</tbody>
</table>

a randomized, sham-controlled trial of cranial electrical stimulation for fibromyalgia pain and physical function, using brain imaging biomarkers

फाइब्रोमायल्गिया एक पुरानी दर्द सिंड्रोम है जो व्यापक लक्षणों के नक्षत्र के साथ प्रस्तुत करता है, जिसमें शारीरिक कार्य, थकान, संज्ञानात्मक गड़बड़ी और अन्य दैहिक शिकायतें शामिल हैं। उपलब्ध उपचार अक्सर लक्षणों के इलाज में अपर्याप्त होते हैं, अपर्याप्त दर्द नियंत्रण के साथ आमतौर पर प्रयास किए गए प्रबंधन के लिए ओपिओइड उपयोग होता है। कपाल विद्युत उत्तेजना (सीईएस) दर्द की स्थिति के लिए एक आशाजनक गैर-फार्माकोलॉजिकल उपचार विकल्प है जो ट्रांसक्यूटेनियस इलेक्ट्रोड के माध्यम से मस्तिष्क समारोह को संशोधित करने के लिए स्पंदित विद्युत प्रवाह उत्तेजना का उपयोग करता है। इन तंत्रिका तंत्र और फाइब्रोमायल्गिया लक्षण राहत में सीईएस के अनुप्रयोगों को आगे की खोज की आवश्यकता होती है।
अटलांटा वेटरन्स अफेयर्स हेल्थकेयर सिस्टम (वीएएचसीएस) के कुल 50 प्रतिभागियों को फाइब्रोमायल्गिया का निदान किया गया था और फिर प्लेसबो प्लस मानक चिकित्सा या सक्रिय सीईएस प्लस मानक चिकित्सा समूह में ब्लॉक-यादृच्छिक किया गया था। उपचार शुरू होने से पहले आधारभूत आकलन प्राप्त किए गए थे। दोनों हस्तक्षेप 12 सप्ताह में हुए, और प्रतिभागियों का मूल्यांकन उपचार शुरू होने के 6 सप्ताह और 12 सप्ताह बाद किया गया। प्राथमिक परिणाम ने जांच की कि क्या सीईएस के आवेदन के साथ दर्द और कार्यात्मक सुधार होते हैं। इसके अतिरिक्त, बेसलाइन और अनुवर्ती आराम राज्य कार्यात्मक कनेक्टिविटी चुंबकीय अनुनाद इमेजिंग (आरएस-एफसीएमआरआई) तंत्रिका कनेक्टिविटी बायोमार्कर के नैदानिक अनुप्रयोगों और उपचार प्रभावों से संबंधित अंतर्निहित तंत्रिका संघों के लिए आकलन करने के लिए 6 सप्ताह और 12 सप्ताह के समय बिंदुओं पर प्राप्त किए गए थे।
यह फाइब्रोमायल्गिया में दर्द और कार्य में सुधार के लिए सीईएस की प्रभावकारिता निर्धारित करने के लिए एक यादृच्छिक, प्लेसबो-नियंत्रित परीक्षण है और तंत्रिका सहसंबंधों और पुराने दर्द और एनाल्जेसिक प्रतिक्रिया के तंत्र का आकलन करने के लिए नैदानिक उपकरण के रूप में आरएस-एफसीएमआरआई विकसित करता है।

Of the many existing states of chronic pain, one of the most notoriously difficult diseases to diagnose, clinically assess, and treat is fibromyalgia. Fibromyalgia is a debilitating chronic pain syndrome that involves chronic widespread pain, decreased physical function, fatigue, psycho-emotional and sleep disturbances, and various somatic complaints affecting approximately 2-3% of the general population in the Americas (about 8 million people in the U.S.)1. Diagnosis of the disease is heavily reliant on a patient&#39;s understanding of their own symptom profile and pain experience, and without that proper understanding by both clinician and patient of the disease, methods of treatment lose considerable efficacy2. A better definition of fibromyalgia&#39;s origins and impact as well as a reliable clinical biomarker to guide fibromyalgia diagnosis and treatment&#160;are necessary to best serve all patients.
Even with a confirmed diagnosis, difficulties with the treatment process only grow. As a whole, chronic pain affects more individuals than heart disease, diabetes, and cancer combined. The subjective nature of its assessment places it as a primary driver for the opioid epidemic, especially given the difficulty in discerning incompletely treated physical pain from substance use disorder and drug-seeking behavior3. In 2020, 91,799 drug overdose deaths occurred in the United States (a 30% increase from 2019), and opioids were found to be the main cause of these deaths (74.8% of all 2020 drug overdose deaths)4. Thus, non-pharmacologic alternatives are needed for chronic pain and fibromyalgia treatment to slow the opioid epidemic, which is particularly important in the veteran population where the risk of suicide and opioid use disorder is higher5. Non-pharmacologic and complementary therapies are therefore often used as first-line treatments6.
The search for novel, efficacious fibromyalgia interventions has led many researchers and clinicians to methods of noninvasive brain stimulation, including cranial stimulation. Even though the pathophysiologic mechanisms that result in the development of the disease have not been definitively determined, existing evidence supports the idea that fibromyalgia is a disorder of autonomic nervous system dysfunction and central (i.e., brain and spinal cord) pain processing mechanisms7,8. Stimulation of certain areas of the brain could lead to improved function in those areas of processing. Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) have been correlated with reductions in pain but have also been associated with activation site scalp irritation, headaches, and inaccessibility outside of treatment facilities9. Noninvasive vagus nerve stimulation (nVNS), which can provide neuromodulation through stimulation over the skin at the neck or at the level of the ear, has the potential for the treatment of chronic pain, and invasive vagus nerve stimulation (VNS) has been shown to improve chronic pain symptoms10. However, neither invasive nor noninvasive VNS have been sufficiently explored in the literature or fully validated for use in fibromyalgia treatment11,12,13,14.
Cranial electrical stimulation (CES) is a non-pharmacological, noninvasive brain stimulation treatment that consists of pulsed, alternating microcurrent (less than 0.5 mA) applied via transcutaneous electrodes placed on the earlobes15. It is remarkably accessible and can be delivered through portable devices used by patients within their own living spaces. In comparison to other cranial stimulation methods, the noninvasive nature and the convenience of patient self-application at home increases the potential of CES as a beneficial option for widespread fibromyalgia treatment use and self-management of pain. It has been cleared by the U.S. Food and Drug Administration (FDA) as a treatment for insomnia, depression, anxiety, and pain15.
The current study evaluates the efficacy of CES as a fibromyalgia treatment modality by comparing active CES (administered by a true study device) versus sham CES (administered by a sham study device). There is some preliminary evidence to support the use of CES in the treatment of pain conditions such as fibromyalgia16,17. A 2001 study of 60 participants randomized to active or sham CES for 3 weeks of daily 60 min sessions revealed a 28% improvement in tender point scores, 27% improvement in general pain scores, and no placebo effect18. CES has not been evaluated in a veteran population, nor has it been adequately evaluated in males with fibromyalgia. A Veterans Affairs (VA)-funded systematic review of CES published in 2018 concluded that evidence is insufficient for CES to have clinically important effects on fibromyalgia, given that most trials had small sample sizes, short durations, and a high risk of bias due to inadequate blinding. However, the review suggests that CES does not cause serious side effects, and there is low-strength evidence to suggest modest benefits in patients with anxiety and depression19. Therefore, further research is warranted regarding the use of this FDA-cleared, low-risk device, particularly in fibromyalgia.
In order to fully evaluate the efficacy, researchers assessed physical fitness alongside neural biomarkers and pain experience. The purpose of treating chronic pain states is to improve physical function. Fibromyalgia is consistently correlated with negative effects on both physical function and patients&#39; perception of their own physical abilities20. Previous studies have utilized simple physical fitness assessments to determine stamina and mobility, such as the 6 Minute Walk Test (6MWT)20,21, Five Time Sit to Stand (5TSTS)20, and various measures of carrying capacity and strength in the context of daily activities22. To account for standard measures while also mitigating the amount of strenuous activity required right before an MRI scan, the study team used the 30-Second Chair Sit Stand Test as a measure of stamina and mobility and both bicep curls and a hand grip test as measures of strength23. The movements required in each of these assessments are very common in everyday activities, so it is a clear measure of how people are physically functioning in their day-to-day lives, both with and without treatment.
Even with subjective pain assessments and physical function measures of efficacy, the mechanisms of CES are not fully understood. Prior neuroimaging studies have sought a better understanding by exploring the direct effect of CES on network connectivity in the brain. Feusner et al.24 found that CES is associated with cortical deactivation for 0.5 Hz and 100 &#181;A stimulation of bilateral frontal, parietal, and posterior midline regions and postulated that frequency of stimulation may have more of an effect than current intensity in relation to cortical deactivation. Their group found significant effects on some but not all nodes of the default mode network (DMN). The authors suggest that based on this data, CES may affect resting state functional connectivity. Fibromyalgia and other chronic pain states have been shown to affect intrinsic brain connectivity in regions associated with pain and perception25,26, so treatments that alter functional connectivity in response could prove to be both beneficial and effective. Further exploration of the longer-term effects of daily treatment in relation to clinical improvement, as well as how deceased activation in the brain relates to previously observed decreases in electroencephalogram frequencies, is needed to further understand the therapeutic mechanism of action27.
Resting-state functional connectivity magnetic resonance imaging (rs-fcMRI) is the neuroimaging method that allows for the observation of these functional connectivity changes. Longitudinal resting state fMRI allows clinicians and researchers to establish a baseline of resting state connectivity and track alterations over time in response to CES treatment methods. It also helps to determine how changes in functional connectivity are correlated to differences in the experience of pain. Initial studies of neuroimaging for fibromyalgia used positron emission tomography (PET) and single-photon-emission computed tomography (SPECT) to examine the brain, but there are issues with both techniques in this regard: SPECT has a lower resolution than PET, and PET scans are invasive, which is not preferable for patients experiencing chronic pain. Functional magnetic resonance imaging (fMRI) scans have greater resolution than SPECT, but they examine brain activity in response to patients&#39; specific actions or perceptions of stimuli28. It is rs-fcMRI scans that can outline functional connectivity between regions of the brain and may be able to determine where and how fibromyalgia exists as well as the best methods of treatment28.
Evaluating the efficacy of non-pharmacologic treatments for pain conditions such as fibromyalgia is of utmost importance both in the current setting of the opioid epidemic and in examining chronic pain as a risk factor for suicide29,30, which is substantially increased among the veteran population. Additionally, the lack of adequate clinical biomarkers for pain is a recognized knowledge gap. Using a combination of behavioral measures and neuroimaging at multiple timepoints to assess treatment response is a novel approach to fibromyalgia evaluation, as is the utilization of auricular CES as a treatment.
The protocol aims to address the gap in fibromyalgia research by investigating the effects of CES on pain and physical function outcomes and evaluating neuroimaging as a tool for predictive and response biomarkers related to the clinical outcomes of CES therapy31.

लेखक स्पॉटलाइट: क्रोनिक दर्द प्रबंधन अनुसंधान के तरीके और प्रगति

मस्तिष्क इमेजिंग बायोमार्कर का उपयोग करके फाइब्रोमायल्गिया दर्द और शारीरिक कार्य के लिए कपाल विद्युत उत्तेजना का एक यादृच्छिक, शम-नियंत्रित परीक्षण

We are trying to address two main issues with regards to pain research. The first is the need for non-invasive, non-pharmacologic therapies that can be effectively administered to individuals suffering from chronic pain. The second is the development of reliable biomarkers, such as the neuroimaging that we're using for the purposes of assessing both fibromyalgia pain and treatment response.The development and access of multiple open source neuro software packages allows for the streamlined use of neuroimaging data analysis. Many of these tools such as fMRIPrep allow researchers who are not familiar with the neuroimaging practices to complete critical pre-processing steps. To maintain blinding, we're unable to titrate for effect using the device as we would in a clinical setting.The stimulation is typically below the perceptual threshold, but we may be underdosing individuals in our study's treatment group, which causes a smaller effect size and difference between the groups. Cranial electrical stimulation is non-invasive. It's low risk, and it's accessible enough to be self-administered by participants in their own home settings.We can also extract usage rates from each of the research devices to properly evaluate compliance with the treatment. And resting state functional connectivity MRI allows us to assess changes in the brain that may occur as a result of our treatment. We anticipate that our research will further guide biomarker development using neuroimaging as a tool.This contributes to a better understanding of the neural basis of pain, and our hope is that these techniques will eventually be used to guide clinical diagnosis and decision making for individuals suffering from pain.

भर्ती परिणामों के संदर्भ में, प्रतिभागियों को मुख्य रूप से अटलांटा वीए हेल्थकेयर सिस्टम के उल्लिखित नियमों के आधार पर भर्ती पत्रों और अनुवर्ती फोन कॉल के माध्यम से भर्ती किया गया था। अध्य...

Read this Scientific Article Protocol about Author Spotlight: Towards Biomarker Development Using Neuroimaging as a Tool to Enhance the Understanding of the Neural Basis of Pain at JoVE.com

वर्तमान अध्ययन फाइब्रोमायल्गिया में दर्द और कार्य में सुधार के लिए कपाल विद्युत उत्तेजना (सीईएस) की प्रभावकारिता निर्धारित करने के लिए एक यादृच्छिक, प्लेसबो-नियंत्रित परीक्षण है और तंत्रिका सहसंबंधों और पुराने दर्द और एनाल्जेसिक प्रतिक्रिया के तंत्र का आकलन करने के लिए एक नैदानिक उपकरण के रूप में आराम कार्यात्मक कनेक्टिविटी चुंबकीय अनुनाद इमेजिंग (आरएस-एफसीएमआरआई) विकसित करता है।

Fibromyalgia is a chronic pain syndrome that presents with a constellation of broad symptoms, including decreased physical function, fatigue, cognitive ...

हम दर्द अनुसंधान के संबंध में दो मुख्य मुद्दों को संबोधित करने की कोशिश कर रहे हैं। पहला गैर-इनवेसिव, गैर-फार्माकोलॉजिकल उपचारों की आवश्यकता है जो पुराने दर्द से पीड़ित व्यक्तियों को प्रभावी ढंग से प्रशासित किया जा सकता है। दूसरा विश्वसनीय बायोमाकर्स का विकास है, जैसे कि न्यूरोइमेजिंग जिसका उपयोग हम फाइब्रोमायल्गिया दर्द और उपचार प्रतिक्रिया दोनों का आकलन करने के उद्देश्यों के लिए कर रहे हैं।कई ओपन सोर्स न्यूरो सॉफ्टवेयर पैकेजों का विकास और पहुंच न्यूरोइमेजिंग डेटा विश्लेषण के सुव्यवस्थित उपयोग की अनुमति देता है। इनमें से कई उपकरण जैसे कि fMRIPrep उन शोधकर्ताओं को अनुमति देते हैं जो महत्वपूर्ण प्री-प्रोसेसिंग चरणों को पूरा करने के लिए न्यूरोइमेजिंग प्रथाओं से परिचित नहीं हैं। अंधा बनाए रखने के लिए, हम डिवाइस का उपयोग करके प्रभाव के लिए अनुमापन करने में असमर्थ हैं जैसा कि हम नैदानिक सेटिंग में करेंगे।उत्तेजना आम तौर पर अवधारणात्मक सीमा से नीचे होती है, लेकिन हम अपने अध्ययन के उपचार समूह में व्यक्तियों को कम कर सकते हैं, जो समूहों के बीच एक छोटे प्रभाव आकार और अंतर का कारण बनता है। कपाल विद्युत उत्तेजना गैर-आक्रामक है। यह कम जोखिम वाला है, और यह प्रतिभागियों द्वारा अपने स्वयं के घर की सेटिंग में स्व-प्रशासित होने के लिए पर्याप्त सुलभ है।हम उपचार के अनुपालन का ठीक से मूल्यांकन करने के लिए प्रत्येक शोध उपकरणों से उपयोग दर भी निकाल सकते हैं। और आराम करने वाले राज्य कार्यात्मक कनेक्टिविटी एमआरआई हमें मस्तिष्क में परिवर्तन का आकलन करने की अनुमति देता है जो हमारे उपचार के परिणामस्वरूप हो सकता है। हम आशा करते हैं कि हमारा शोध एक उपकरण के रूप में न्यूरोइमेजिंग का उपयोग करके बायोमार्कर विकास को आगे बढ़ाएगा।यह दर्द के तंत्रिका आधार की बेहतर समझ में योगदान देता है, और हमारी आशा है कि इन तकनीकों का उपयोग अंततः दर्द से पीड़ित व्यक्तियों के लिए नैदानिक निदान और निर्णय लेने के मार्गदर्शन के लिए किया जाएगा।

a-randomized-sham-controlled-trial-cranial-electrical-stimulation-for

Research

JoVE Journal

Medicine

A Randomized, Sham-Controlled Trial of Cranial Electrical Stimulation for Fibromyalgia Pain and Physical Function, Using Brain Imaging Biomarkers

Fibromyalgia is a chronic pain syndrome that presents with a constellation of broad symptoms, including decreased physical function, fatigue, cognitive disturbances, and other somatic complaints. Available therapies are often insufficient in treating symptoms, with inadequate pain control commonly leading to opioid usage for attempted management. Cranial electrical stimulation (CES) is a promising non-pharmacologic treatment option for pain conditions that uses pulsed electrical current stimulation to modify&#160;brain function via transcutaneous electrodes. These neural mechanisms and the applications of CES in fibromyalgia symptom relief require further exploration.
A total of 50 participants from the Atlanta Veterans Affairs Healthcare System (VAHCS) diagnosed with fibromyalgia were enrolled and then block-randomized into either a placebo plus standard therapy or active CES plus standard therapy group. Baseline assessments were obtained prior to the start of treatment. Both interventions occurred over 12 weeks, and participants were assessed at 6 weeks and 12 weeks after treatment initiation. The primary outcome investigated whether pain and functional improvements occur with the application of CES. Additionally, baseline and follow-up resting state functional connectivity magnetic resonance imaging (rs-fcMRI) were obtained at the 6-week and 12-week time points to assess for clinical applications of neural connectivity biomarkers and the underlying neural associations related to treatment effects.
This is a randomized, placebo-controlled trial to determine the efficacy of CES for improving pain and function in fibromyalgia and further develop rs-fcMRI as a clinical tool to assess the neural correlates and mechanisms of chronic pain and analgesic response.

The current study is a randomized, placebo-controlled trial to determine the efficacy of cranial electrical stimulation (CES) for improving pain and function in fibromyalgia and further develop resting functional connectivity magnetic resonance imaging (rs-fcMRI) as a clinical tool to assess the neural correlates and mechanisms of chronic pain and analgesic response.