Clinical trial NCT04069572: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Chronic Pain
Pelvic Pain
Functional Abdominal Pain Syndrome
Low Back Pain
Migraine
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment Responder
timeFrame: 30 days
measure: Change in Opioid Use
timeFrame: 30 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 60 days
measure: Secondary Treatment Response After Crossover
timeFrame: 60 days
measure: Change in monthly migraine days
timeFrame: 30 days
measure: Treatment Engagement
timeFrame: 30 days
measure: Treatment Initiation
timeFrame: 30 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Neuroscience Health Center
state: California
Study officials:
affiliation: Stanford University
name: Jennifer M Hah, MD
role: PRINCIPAL_INVESTIGATOR
References: