Vibratory Stimulation for the Treatment of Chronic Pain

Recruitment & Eligibility

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.
1. Frequent/chronic tension type headache

Study & Design

Arm && Interventions

Group	Intervention	Description
Vibrotactile Stimulation	Vibrotactile Stimulation	-
Sham Stimulation	Sham Stimulation	-

Primary Outcome Measures

Name	Time	Method
Treatment Responder	30 days	Proportion of subjects in the treatment vs. placebo groups that are responders with greater than or equal to 50% reductions in average pain (in the primary pain area) comparing the average pain score from the 7-day baseline diary pre-treatment to the average scores based on 7-day diaries at the end of the primary outcome interval
Change in Opioid Use	30 days	Change in opioid use in daily oral morphine equivalents from the average 7-day baseline use to the post-treatment use in the 7 days at the end of the primary outcome interval.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	60 days	The proportion of adverse events occurring in the treatment vs. placebo groups
Secondary Treatment Response After Crossover	60 days	The proportion of subjects in the treatment vs. placebo groups that are responders at the end of 60 days comparing the average pain score from the 7- day baseline diary pre-treatment to the reported pain score at the end of the 60 day interval.
Treatment Engagement	30 days	Treatment engagement is defined as participation in \>50% of home treatment sessions.
Change in monthly migraine days	30 days	For patients with migraine, change in monthly migraine days between the 30 days before randomization and the end of the primary outcome interval.
Treatment Initiation	30 days	Treatment initiation is defined as participation in at least 1 home treatment session. session.

Recruitment & Eligibility