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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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.
Low-frequency sham of VCR stimulation
Stanford Neuroscience Health Center
Palo Alto, California, United States
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
Time frame: 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.
Time frame: 30 days
Adverse Events
The proportion of adverse events occurring in the treatment vs. placebo groups
Time frame: 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.
Time frame: 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.
Time frame: 30 days
Treatment Engagement
Treatment engagement is defined as participation in \>50% of home treatment sessions.
Time frame: 30 days
Treatment Initiation
Treatment initiation is defined as participation in at least 1 home treatment session. session.
Time frame: 30 days
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