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Behavioural Intervention

Auricular Neuromodulation for Fibromyalgia

N/A

Recruiting

Led By Anna Woodbury, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Intact skin in area of PENFS treatment

Diagnosis of fibromyalgia by the American College of Rheumatology 2016 criteria

Must not have

Autoimmune disease that leads to pain

History of seizures or neurologic conditions that alter the brain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Summary

This trial is testing a therapy called PENFS, which is like acupuncture but targets specific nerves in the ear to help with pain, physical function, and reduce symptoms of opioid withdrawal. Previous studies have shown

Who is the study for?

This trial is for veterans with fibromyalgia, a chronic pain condition. Participants should have symptoms that match the criteria for myofascial pain syndrome or fibromyalgia. Specific eligibility details are not provided but typically include factors like age, overall health, and severity of symptoms.

What is being tested?

The study tests PENFS (percutaneous electrical nerve field stimulation), an FDA-approved therapy similar to acupuncture but on the ear. It aims to improve pain and physical function by stimulating nerves. The effectiveness will be measured using MRI scans that assess brain activity at rest.

What are the potential side effects?

While specific side effects are not listed here, typical reactions to nerve stimulation can include discomfort at the site of application, headache, dizziness or skin irritation. Since it's non-pharmacologic, systemic side effects like those from drugs may be less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin is healthy where the PENFS treatment will be applied.

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I have been diagnosed with fibromyalgia according to the 2016 criteria.

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I have experienced significant pain (4 or higher) in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease that causes me pain.

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I have a history of seizures or brain conditions.

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I have skin conditions that could raise infection risk where treatments are applied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvements in Clinical Pain (DVPRS)

Improvements in Clinical Pain (Self-reported analgesic consumption)

Secondary study objectives

Changes in Fibromyalgia Severity (FIQ-R)

Changes in Fibromyalgia Severity (PSD)

Functional Improvements (30-s chair stand)

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: True PENFSActive Control1 Intervention

Percutaneous electrical nerve stimulation applied to the ear x 4 over a 4 week period. The device is placed over the area of the ear and worn home continuously for a 5-day period, during which time it stimulates at a pre-set on/off duty cycle. At each in-person visit, the device is replaced until the device has been placed 4 times. The stimulation delivered is below the threshold of sensory perception.

Group II: Sham PENFSPlacebo Group1 Intervention

A device is placed at the same points for the same amount of time and at the same intervals as the true device. This device will not deliver electrical stimulation.

0 / 6Eligibility criteria met