SuspendedNot Applicable

Vibratory Stimulation for the Treatment of Chronic Pain

Stopped: New investigational devices are currently under development.

United States50 participantsStarted 2026-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Responder

Timeframe: 30 days

Change in Opioid Use

Timeframe: 30 days

Trial details

NCT IDNCT04069572

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Chronic Pain trials