Vibratory Stimulation for the Treatment of Chronic Pain

Chronic Pain Clinical Trial

Official title:

Patterned Multichannel Vibratory Coordinated Reset (VCR) Stimulation for the Treatment of Chronic Pain

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04069572
• Other study ID #: 52019
• Status: Suspended
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Chronic Pain
• Functional Abdominal Pain Syndrome
• Low Back Pain
• Migraine
• Pelvic Pain

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Stanford Neuroscience Health Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Primary	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.	30 days
Secondary	Adverse Events	The proportion of adverse events occurring in the treatment vs. placebo groups	60 days
Secondary	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.	60 days
Secondary	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.	30 days
Secondary	Treatment Engagement	Treatment engagement is defined as participation in >50% of home treatment sessions.	30 days
Secondary	Treatment Initiation	Treatment initiation is defined as participation in at least 1 home treatment session. session.	30 days