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Vibratory Stimulation for the Treatment of Chronic Pain

SuspendedNot applicableNCT04069572
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Patterned Multichannel Vibratory Coordinated Reset (VCR) Stimulation for the Treatment of Chronic Pain
Conditions
Interventions
  • Device: Vibrotactile Stimulation
  • Device: Sham Stimulation
Sponsor
Stanford University
Start date
2026-09
Primary completion
2027-09
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04069572