Vibratory Stimulation for the Treatment of Chronic Pain
NCT ID: NCT04069572
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
50 participants
INTERVENTIONAL
2026-09-30
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Vibrotactile Stimulation
Vibrotactile Stimulation
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.
Sham Stimulation
Sham Stimulation
Low-frequency sham of VCR stimulation
Interventions
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Vibrotactile Stimulation
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.
Sham Stimulation
Low-frequency sham of VCR stimulation
Eligibility Criteria
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Inclusion Criteria
* 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 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
4\. Frequent/chronic tension type headache
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Jennifer Hah
Assistant Professor
Principal Investigators
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Jennifer M Hah, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Neuroscience Health Center
Palo Alto, California, United States
Countries
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Other Identifiers
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52019
Identifier Type: -
Identifier Source: org_study_id
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