Vibratory Stimulation for the Treatment of Chronic Pain
Vibratory Stimulation for the Treatment of Chronic Pain
The purpose of this study is to perform a first in man study with VCR stimulation of the
 belly and back for patients with chronic pain conditions including pelvic pain, functional
 abdominal pain, or low back pain. This study will also examine VCR stimulation of the
 temporal region for patients with migraine with or without aura. Additional goals of the
 study will be to determine the safety, tolerability, and acceptability of VCR stimulation for
 the treatment of these pain conditions.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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 suicidality as assessed by answer of greater than 0 on question 9 the PHQ-9
 assessing suicidal thoughts.

 -  Any current illicit drug or alcohol abuse.

 -  Any history of recurrent or unprovoked seizures.

 -  Participation in another drug, device, or biologics trial concurrently or within the
 preceding 30 days.

 -  Pregnancy, breast-feeding or lack of reliable contraception

 -  Changes in pain medications in the previous 4 weeks

 -  Implanted electrical stimulation device.

 -  Skin infection over stimulation sites.

 -  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.

 4. Frequent/chronic tension type headache