Vibratory Stimulation for the Treatment of Chronic Pain

Patterned Multichannel Vibratory Coordinated Reset (VCR) 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.

Study Overview

• Status: Suspended
• Conditions: Low Back Pain; Chronic Pain; Migraine; Pelvic Pain; Functional Abdominal Pain Syndrome
• Intervention / Treatment: Device: Vibrotactile Stimulation; Device: Sham Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Neuroscience Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Stimulation	Device: Sham Stimulation; Low-frequency sham of VCR stimulation
Experimental: Vibrotactile Stimulation	Device: Vibrotactile Stimulation; Application of VCR stimulation to the belly and back of patients with pelvic pain, functional abdominal pain, or low back pain or to the temporal region for patients with migraine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Responder	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	30 days
Change in Opioid Use	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	The proportion of adverse events occurring in the treatment vs. placebo groups	60 days
Secondary Treatment Response After Crossover	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.	60 days
Change in monthly migraine days	For patients with migraine, change in monthly migraine days between the 30 days before randomization and the end of the primary outcome interval.	30 days
Treatment Engagement	Treatment engagement is defined as participation in >50% of home treatment sessions.	30 days
Treatment Initiation	Treatment initiation is defined as participation in at least 1 home treatment session. session.	30 days

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jennifer M Hah, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Chronic Pain; Low Back Pain; Pelvic Pain
• Other Study ID Numbers: 52019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No