Analgesic Efficacy and MultiDimensional Outcomes of Bilateral Ultrasound Guided Cervical Vagal Nerve Hydrodilatation in Fibromyalgia Patients An Exploratory Single Arm Study

Fibromyalgia FM is a complex multifactorial disorder characterized primarily by Chronic Widespread Pain cWSP predominantly Musculoskeletal in Origin alongside a constellation of other Symptoms including Fatigue Sleep Disturbances Cognitive Dysfunction Anxiety and Depression the latter constellation frequently described as Fibro Fog that significantly reduce Quality of Life QoL

Pharmacological Therapies for fibromyalgia with moderate evidence include Duloxetine Milnacipran and Pregabalin which provide short to mediumterm pain relief while Antidepressants and CNS Depressants show smaller benefits

Conservative Approaches such as Cognitive Behavioural Therapy Multimodal Exercise Programs Including Aquatic and Combined Exercises Manual Therapy and Patient Education have Strong Evidence for reducing Pain and Disability in the Short

Medium and Long Term Interventional Methods like transcutaneous electrical Nerve Stimulation and Magnetic Field Therapy show promise for ShortTerm pain reduction but lack robust Long Term Data

Hypotheses supporting repeated Trancutaneous Vagus Nerve Stimulation tVNS Sessions normalize Autonomic Imbalance reduce Chronic MultiSite Pain and improve Visceral Symptoms by restoring Vagal Control over Nociceptive and ImmuneInflammatory Systems hence offering a promising NeuroModulatory Intervention NMI targeting Autonomic Dysfunction in Fibromyalgia

Peripheral Nerve PN HydroDissection HD with Dextrose 5 percent wv in Water D5W of Peripheral Nerves is increasingly utilized particularly in Entrapment Neuropathies like Carpal Tunnel Syndrome CTS

However Recently the FIRST CASE of Therapeutic HydroDissection HD of the Bilateral Vagus Nerves in the Carotid Sheath under Point of Care Ultrasound guidance POCUSG with D5W WITHOUT Local Anesthetic LA for Chronic Widespread Pain cWSP in a Patient with Fibromyalgia FM demonstrated favorable Outcomes in reducing MultiSite Pain as well as in reducing Depressive and Autonomic Symptoms

In our Current Proposed Study we hypothesize that this Novel Intervention ie Bilateral Ultrasound Guided Cervical Vagal Nerve Hydrodilatation is a beneficial adjunct to the Current Standard Of Care Dual Drug Pharmacotherapy and is deemed to be Clinically and Procedurally Safe due to being devoid of Local Anaesthetic use around the Hydrodissection of Bilateral Vagus Nerves and by Virtue of being performed under POCUS Guidance respectively

We also hypothesize it to be an efficacious not only in reducing Chronic Widespread Pain of Fibromyalgia but also enhance MultiDimensional NeuroModulatory Outcomes of reducing Clinical Depression and improving Parasympathetic Cardiovascular Autonomous Functioning as studied by Pre and Post Intervention Scores of WPI SSS ODI PHQ9 as well as Heart Rate Variability Based Autonomic Function Tests in Patients of Dual Drug Resistant Fibromyalgia ie Duloxetine least 40 mg per Day and Pregabalin at least 150 mg per Day consumed for at least past 3 months with a Preintervention WPI greater than or equal to 7 as well as SSS greater than or equal to 7 and ODI greater than or equal to 50 percent

We purport that the Results of the Study shall add to a justified Advancement to an emerging Scientific Discipline of Pain Medicine in a relatively recent DifficulttoTreat Disease Complex ie Fibromyalgia