search
Back to results

Vibratory Stimulation for the Treatment of Chronic Pain

Primary Purpose

Chronic Pain, Pelvic Pain, Functional Abdominal Pain Syndrome

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibrotactile Stimulation
Sham Stimulation
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Neuroscience Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Vibrotactile Stimulation

Sham Stimulation

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Adverse Events
The proportion of adverse events occurring in the treatment vs. placebo groups
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.
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.
Treatment Engagement
Treatment engagement is defined as participation in >50% of home treatment sessions.
Treatment Initiation
Treatment initiation is defined as participation in at least 1 home treatment session. session.

Full Information

First Posted
August 23, 2019
Last Updated
October 18, 2023
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT04069572
Brief Title
Vibratory Stimulation for the Treatment of Chronic Pain
Official Title
Patterned Multichannel Vibratory Coordinated Reset (VCR) Stimulation for the Treatment of Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
New investigational devices are currently under development.
Study Start Date
September 2024 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pelvic Pain, Functional Abdominal Pain Syndrome, Low Back Pain, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vibrotactile Stimulation
Arm Type
Experimental
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Vibrotactile Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Stimulation
Intervention Description
Low-frequency sham of VCR stimulation
Primary Outcome Measure Information:
Title
Treatment Responder
Description
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
Time Frame
30 days
Title
Change in Opioid Use
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Adverse Events
Description
The proportion of adverse events occurring in the treatment vs. placebo groups
Time Frame
60 days
Title
Secondary Treatment Response After Crossover
Description
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.
Time Frame
60 days
Title
Change in monthly migraine days
Description
For patients with migraine, change in monthly migraine days between the 30 days before randomization and the end of the primary outcome interval.
Time Frame
30 days
Title
Treatment Engagement
Description
Treatment engagement is defined as participation in >50% of home treatment sessions.
Time Frame
30 days
Title
Treatment Initiation
Description
Treatment initiation is defined as participation in at least 1 home treatment session. session.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M Hah, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Neuroscience Health Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vibratory Stimulation for the Treatment of Chronic Pain

We'll reach out to this number within 24 hrs