Vibratory Stimulation for the Treatment of Chronic Pain

Stanford University

Status

Suspended

Conditions

Pelvic Pain

Chronic Pain

Migraine

Functional Abdominal Pain Syndrome

Low Back Pain

Treatments

Device: Vibrotactile Stimulation

Device: Sham Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04069572

52019

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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