Status:
SUSPENDED
Vibratory Stimulation for the Treatment of Chronic Pain
Lead Sponsor:
Stanford University
Conditions:
Chronic Pain
Pelvic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04069572
Start Date
September 1 2026
End Date
December 1 2027
Last Update
November 27 2024
Active Locations (1)
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1
Stanford Neuroscience Health Center
Palo Alto, California, United States, 94304