Health Condition 1: M797- Fibromyalgia
Conditions
Interventions
Intervention1: Point of Care Ultrasound Guided Bilateral Cervical Vagus Nerves 5 Percent Dextrose Water Hydrodilatation: 20 ml of Sterile 5 Percent Dextrose Water Injected through 22 G Sterile Hypoder
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1 Diagnosed as Fibromyalgia as per 2016 ACR Revised Preliminary Clinical Criteria for FM 2 Already on Dual-Drug Therapy of Duloxetine at least 40 mg per Day and Pregabalin at least 150 mg per Day for at least 3 months continued in the same Dosages during the duration of the Study 3 Pre-Intervention Baseline WPI greater than or equal to 7 4 Pre-Intervention Baseline SSS greater than or equal to 7 5 Pre-Intervention Baseline ODI greater than or equal to 50 percent 6 Pre-Intervention Baseline PHQ-9 greater than or equal to 10 7 Undergoing Pre-Intervention Baseline as well as Day 30 not exceeding day 90 Post-intervention for Heart Rate Variability Based Autonomic Function Tests
Exclusion criteria
Exclusion criteria: 1 Patients on Anti Platelet Anti Coagulant Medication 2 Patients with any of these known Co Morbidities Uncontrolled Severe Cardiovascular Disease e.g. Severe Uncontrolled Systemic Hypertension greater than or equal to 180 90 mmHg NIBP Cardiac Dys Rhythmias with or without Implantable Pacemakers Cardioverter Defibrillators Severe Valvular heart Diseases any Causes of reduced Cardiac Ejection Fraction less than 40 percent any other Cardiovascular Disease Dysfunction qualifying as American Society of Anesthesiologists Physical Status Classification PS III or IV 3 or 4 3 Patients with Diagnosed Coagulopathy s 4 Women with Confirmed Pregnancy 5 Patients with a known observed Allergy to Ultrasound Conducting Jelly Rarely so
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnitude of Interval Change from pre-intervention Baseline in WPI at Days 30, 60 & 90 Post-Intervention.Timepoint: Pre Intervention and at Days 30,60 & 90 Post-Intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Magnitude of Interval Change in from pre-intervention Baseline SSS at Days 30, 60 & 90 Post-Intervention.Timepoint: Pre-Intervention & Days 30, 60 & 90 Post-Intervention.;Magnitude of Interval Change from pre-intervention Baseline in ODI at Days 30, 60 & 90 Post-Intervention.Timepoint: Pre-Intervention & Days 30, 60 & 90 Post-Intervention.;Magnitude of Interval Change from pre-intervention Baseline in PHQ-9 Score for Severity of Clinical Depression at Days 30, 60 & 90 Post-Intervention.Timepoint: Pre-Intervention & Days 30, 60 & 90 Post-Intervention.;Magnitude of Interval Change from pre-intervention Baseline in each of the Heart Rate Variability Based Tests of Autonomic Functions at Days 30, 60 & 90 post- Intervention.Timepoint: Pre-Intervention & Days 30, 60 & 90 Post-Intervention. | — |
Countries
India
Contacts
Public ContactDr Praveen Talawar
AIIMS Rishikesh
Outcome results
None listed