Chronic PainNCT04069572
Vibratory Stimulation for the Treatment of Chronic Pain
A study testing Vibrotactile Stimulation in people with Chronic Pain and Pelvic Pain, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Pelvic Pain, Functional Abdominal Pain Syndrome
- What is being tested?
- Vibrotactile Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Neuroscience Health Center
Palo Alto, California, 94304
About this study
Official title: 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.
- Being tested
- Vibrotactile Stimulation, Sham Stimulation
- Medical subject headings
- Chronic Pain, Pelvic Pain, Low Back Pain, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile StimulationDevice
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.
Sham StimulationDevice
Low-frequency sham of VCR stimulation
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile Stimulation | Experimental | Not described Receives: Device: Vibrotactile Stimulation |
| Sham Stimulation | Sham comparator | Not described Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 30 days
Secondary outcomes (5)
Adverse Events
The proportion of adverse events occurring in the treatment vs. placebo groups
Measured: 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.
Measured: 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.
Measured: 30 days
Treatment Engagement
Treatment engagement is defined as participation in >50% of home treatment sessions.
Measured: 30 days
Treatment Initiation
Treatment initiation is defined as participation in at least 1 home treatment session. session.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: New investigational devices are currently under development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Hah, Stanford University
- Investigators
- Jennifer M Hah, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069572
- Sponsor's protocol ID
- 52019
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2019
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterned Multichannel Vibratory Coordinated Reset (VCR) Stimulation for the Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT04069572
- Acronym / sponsor ID
- 52019
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: New investigational devices are currently under development.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Stimulation | Experimental | Device: Vibrotactile Stimulation |
| Sham Stimulation | Sham comparator | Device: Sham Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrotactile StimulationApplication 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. | Device | Vibrotactile Stimulation |
| Sham StimulationLow-frequency sham of VCR stimulation | Device | Sham Stimulation |
Primary outcome
Treatment Responder
Time frame: 30 days
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
Change in Opioid Use
Time frame: 30 days
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.
5 secondary outcomes
Adverse Events
Time frame: 60 days
Secondary Treatment Response After Crossover
Time frame: 60 days
Change in monthly migraine days
Time frame: 30 days
Treatment Engagement
Time frame: 30 days
Treatment Initiation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer M Hah, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Stimulation in people with Chronic Pain and Pelvic Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Responder (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.