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Vibratory Stimulation for the Treatment of Chronic Pain
Patterned Multichannel Vibratory Coordinated Reset (VCR) Stimulation for the Treatment of Chronic Pain
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-pain
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
Study Completion
Last participant's last visit for all outcomes
December 1, 2027
April 24, 2026
April 1, 2026
1 year
August 23, 2019
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Adverse Events
60 days
Secondary Treatment Response After Crossover
60 days
Change in monthly migraine days
30 days
Treatment Engagement
30 days
Treatment Initiation
30 days
Study Arms (2)
Vibrotactile Stimulation
EXPERIMENTALSham Stimulation
SHAM COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- \. Frequent/chronic tension type headache
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Neuroscience Health Center
Palo Alto, California, 94304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer M Hah, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 23, 2019
First Posted
August 28, 2019
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share