Vibratory Stimulation for the Treatment of Chronic Pain (NCT04069572) | Clinical Trial Compass
SuspendedNot Applicable
Vibratory Stimulation for the Treatment of Chronic Pain
Stopped: New investigational devices are currently under development.
United States50 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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,…