Vibratory Stimulation for the Treatment of Chronic Pain

Prior treatment

• Any current illicit drug or alcohol abuse.
• Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days.
• Changes in pain medications in the previous 4 weeks
• Any pain interventions in the preceding 6 weeks (epidural steroid injection, sympathetic block, peripheral nerve block, lumbar medial branch blocks) Any botulinum toxin injection in the previous 3 months
• For patients with migraine diagnosis additional exclusion criteria include receipt of preventive anti-migraine treatment in the past 3 months, failure on greater than or equal to 3 well-conducted preventive drug trials, concurrent medication overuse headache diagnosis, and concurrent frequent/chronic tension type headache.
  • Frequent/chronic tension type headache

Other illness

• Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
• Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression
• Any history of recurrent or unprovoked seizures.
• Skin infection over stimulation sites.

Other

• Any suicidality as assessed by answer of greater than 0 on question 9 the PHQ-9 assessing suicidal thoughts.
• Pregnancy, breast-feeding or lack of reliable contraception
• Implanted electrical stimulation device.

• Age greater than or equal to 18 years old.
• Diagnosis of either chronic pelvic pain, functional abdominal pain, axial low back pain, or migraine with or without aura of at least 3 months duration.
• English speaking
• Ability and willingness to complete questionnaires and in-person assessments
• Current average daily pain score of greater than or equal to 4 on the Numeric Rating Scale of Pain (0-10 scale)
• For patients with migraine diagnosis they must report at least 2 headaches in the baseline headache diary in the 30 days preceding randomization.