Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia

Inclusion Criteria

• •1. Willing and able to provide informed consent.
• •2. Age ≥ 22 years.
• •3. Meets 2016 American College of Rheumatology criteria for fibromyalgia:
• •1. Generalized pain, defined as pain in at least 4 of 5 regions, is present, AND
• •2. Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9, AND
• •3. Symptoms have been present at a similar level for at least 3 months, AND
• •4. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.
• •4. Failure of at least two evidence-based medications (i.e., pregabalin, duloxetine, milnacipran) for the treatment of fibromyalgia.
• •5. Failure of one or more attempts at physical or Cognitive Behavioral Therapy (CBT) including:
• •1. Aerobic exercise like walking, cycling, and swimming,
• •2. Water therapy/hydrotherapy with warm water exercises,
• •3. Tai Chi involving slow, controlled movements,
• •4. Yoga,
• •5. Resistance training,
• •6. Bodyweight exercises,
• •7. Pilates,
• •8. Myofascial release therapy applying gentle pressure on trigger points,
• •9. Massage therapy,
• •10. Trigger point therapy targeting specific pain points,
• •11. Joint mobilization,
• •12. Postural retraining to correct body alignment,
• •13. Balance and coordination exercises,
• •14. Feldenkrais method for movement awareness,
• •15. Alexander technique to enhance posture and movement efficiency,
• •16. Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief,
• •17. Heat therapy using hot packs, infrared, or paraffin wax,
• •18. Cold therapy with ice packs or cryotherapy,
• •19. Ultrasound therapy for deep tissue relaxation,
• •20. Biofeedback to control muscle tension and pain response,
• •21. Gentle static stretching for prolonged duration,
• •22. Active dynamic stretching for full range of motion,
• •23. Proprioceptive Neuromuscular Facilitation (PNF) stretching,
• •24. Hydrotherapy pool exercises,
• •25. Ai Chi (water-based Tai Chi),
• •26. Underwater treadmill therapy, aa) Graded motor imagery (GMI), bb) Mirror therapy to retrain brain-body connections, cc) Mindfulness-based stress reduction (MBSR) combining meditation and movement, dd) Balance exercises to improve stability, ee)Gaze stabilization techniques for dizziness and disorientation, ff) CBT.
• •6. Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Screening visit.
• •7. Pain score of ≥ 4 on NRS-11 at Baseline visit averaged over 3 consecutive calendar days.
• •8. Stated willingness and ability to comply with all study procedures.
• •9. Has remained on the same psychiatric treatment regimen (e.g., medication, psychotherapy) for at least one (1) month prior to screening, and has stated willingness to remain on the same regimen for the duration of the study unless a change in treatment is recommended or agreed upon by the site investigator.
• •10. For participants who could potentially become pregnant: negative urine pregnancy test at screening; agreement to use a highly effective method of contraception (≤ 1% pregnancy rate) including tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), or long-acting contraceptives (LARC).