Auricular Neuromodulation for Fibromyalgia

Overseen By Anna M Ree, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Seizures, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called percutaneous electrical nerve field stimulation (PENFS), similar to acupuncture for the ear, to determine its effectiveness for fibromyalgia, a condition causing chronic pain. The study aims to assess how well this treatment reduces pain and improves physical function without relying on medications like opioids. Participants will receive either the actual PENFS treatment or a sham (inactive) version for comparison. The trial seeks individuals diagnosed with fibromyalgia who have experienced significant pain in the past three months. As an unphased trial, it offers a unique opportunity to explore innovative treatments for fibromyalgia without using medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on testing a non-drug therapy, so it's best to ask the trial coordinators for specific guidance.

What prior data suggests that this device is safe for treating fibromyalgia?

Studies have shown that percutaneous electrical nerve field stimulation (PENFS) is quite safe. Research involving over 1,200 patients reported no serious side effects, suggesting that PENFS is generally well-tolerated. The FDA has approved this therapy, indicating it has passed safety checks for other uses. So far, evidence appears promising for its use in people with fibromyalgia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for fibromyalgia, which often include medications like antidepressants, anticonvulsants, and pain relievers, percutaneous electrical nerve field stimulation (PENFS) offers a novel approach. This treatment works by delivering electrical stimulation directly to the nerves in the ear, which is thought to modulate pain pathways without the need for drugs. Researchers are excited about PENFS because it has the potential to provide relief without the side effects commonly associated with medication, and it operates below the threshold of sensory perception, making it a subtle yet promising option. This method could represent a significant advancement in fibromyalgia treatment by offering a non-invasive and potentially more tolerable alternative.

What evidence suggests that PENFS might be an effective treatment for fibromyalgia?

This trial will compare the effects of true percutaneous electrical nerve field stimulation (PENFS) with a sham version. Studies have shown that PENFS can reduce pain and improve function in people with fibromyalgia, a condition causing long-term pain. Research suggests that PENFS works by stimulating certain nerves in the ear, potentially altering how the brain perceives pain. In one study, patients reported significant pain relief after using PENFS, with noticeable improvements in brain areas linked to pain relief. Another study found that veterans with fibromyalgia experienced better pain management and daily functioning after receiving PENFS treatments. These findings suggest that PENFS might be a helpful option for managing fibromyalgia-related pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Anna Woodbury, MD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I can safely undergo an MRI.

Right-handedness, to provide consistency in brain structure and function

Exclusion Criteria

Claustrophobia

MRI-incompatible implants, or other conditions incompatible with MRI (only for those who elect to perform MRI)

History of uncontrolled psychiatric illness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either true or sham auricular PENFS, with the device applied weekly for 4 weeks

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 week, 12 weeks, and 24 weeks post-treatment

24 weeks

3 visits (in-person)

Open-label extension (optional)

Participants initially assigned to sham placebo PENFS and not identified as placebo-responders may opt to test the true PENFS device

What Are the Treatments Tested in This Trial?

Interventions

• Percutaneous electrical nerve field stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: True PENFS Active Control 1 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 PENFS Placebo Group 1 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.

Percutaneous electrical nerve field stimulation is already approved in United States for the following indications:

Approved in United States as IB-Stim for:

• Functional abdominal pain associated with irritable bowel syndrome (IBS) in patients 11-18 years of age

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study involving 21 veterans with fibromyalgia, those receiving auricular percutaneous electrical nerve field stimulation (PENFS) showed a trend toward improved pain scores and significant reductions in pain interference with sleep compared to standard therapy alone after 12 weeks.

Neuroimaging results indicated that PENFS treatment was associated with increased connectivity in brain areas related to pain processing and executive control, suggesting a unique mechanism of action for PENFS in managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial. Woodbury, A., Krishnamurthy, V., Gebre, M., et al.[2023]

Non-invasive neuro-adaptive electrostimulation (NAE) therapy significantly reduced pain in women with fibromyalgia compared to a sham treatment, showing a 3-point improvement on the Visual Analog Scale immediately after the intervention and at 3 months follow-up.

While NAE therapy improved pain and quality of life after 4 weeks, these benefits did not persist at the 3-month follow-up, indicating the need for further research to explore long-term efficacy in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of neuro-adaptive electrostimulation therapy on pain and disability in fibromyalgia: A prospective, randomized, double-blind study. Udina-Cortés, C., Fernández-Carnero, J., Romano, AA., et al.[2021]

A follow-up study of 69 fibromyalgia patients, conducted 45 months after a randomized controlled trial, showed significant long-term improvements in symptoms, with Fibromyalgia Impact Questionnaire scores decreasing from 52.6 at baseline to 31.8 at follow-up (P<.001).

Patients reported lasting benefits from noninvasive cortical stimulation therapy, including reduced medication use and fewer doctor visits for fibromyalgia, indicating the treatment's sustained efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. Hargrove, JB., Bennett, RM., Clauw, DJ.[2015]

In a Phase I/II trial involving 14 patients with treatment-resistant fibromyalgia, vagus nerve stimulation (VNS) was found to be generally safe and tolerable, with side effects similar to those seen in epilepsy and depression treatments, including dry mouth and fatigue.

After 3 months of VNS, 5 out of 12 patients showed significant improvement in pain and overall wellness, with some patients even losing their fibromyalgia diagnosis criteria, suggesting VNS could be a promising adjunct treatment for fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial. Lange, G., Janal, MN., Maniker, A., et al.[2021]

In a study of 21 veterans with fibromyalgia, those receiving auricular percutaneous electric nerve field stimulation (PENFS) alongside standard therapy showed significant changes in cortical thickness, indicating a potential novel effect of PENFS on brain structure compared to standard therapy alone.

Both treatment groups reported reduced pain, but the ST+PENFS group exhibited specific volumetric changes in brain regions associated with pain processing, suggesting that insular GABA levels and cortical thickness could serve as biomarkers for chronic pain and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous electric nerve field stimulation alters cortical thickness in a pilot study of veterans with fibromyalgia. Woodbury, A., Krishnamurthy, LC., Bohsali, A., et al.[2023]

High-frequency (10 kHz) peripheral nerve stimulation has shown promise in treating facial pain, offering rapid and reversible conduction block in nerves, which may enhance analgesic effects beyond just blocking pain signals.

This technique has advantages over traditional low-frequency stimulation, including the absence of uncomfortable sensations (paresthesias) for patients and the flexibility of electrode placement, making it a potentially more effective and patient-friendly option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Frequency Peripheral Nerve Stimulation for Craniofacial Pain. Finch, P., Drummond, P.[2021]

In a study of 100 patients with chronic intractable pain, peripheral nerve field stimulation (PNFS) led to an average pain reduction of 4.2 points on an 11-point scale, indicating significant efficacy in pain management.

The treatment was safe, with no long-term complications reported, and 72% of patients reduced their use of analgesics after PNFS, highlighting its potential to improve quality of life and change pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Verrills, P., Vivian, D., Mitchell, B., et al.[2011]

This study investigates the effects of percutaneous electrical neural field stimulation (PENFS) on fibromyalgia symptoms in 20 adults, aiming to reduce brain connectivity between the default mode network and the insula, which may correlate with pain relief and reduced medication use.

The trial is designed as a feasibility study to assess the practicality of using functional connectivity MRI to explore the neural mechanisms of PENFS, with the goal of informing a larger clinical trial on its efficacy for improving pain and function in fibromyalgia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. Gebre, M., Woodbury, A., Napadow, V., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2452073X22000101

Percutaneous electric nerve field stimulation alters cortical ... Fibromyalgia pain improved following treatment with standard therapy or PENFS. •. Right insular increases in cortical thickness correlated with improved pain ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10515210/

Prospective study of the effect of auricular percutaneous ... Our research demonstrates that PENFS significantly enhances the QoL of children suffering from pain-related DGBIs, in addition to improvement in GI symptoms.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33164085/

Feasibility of Auricular Field Stimulation in Fibromyalgia There was a trend toward improved pain and function among veterans with fibromyalgia in the ST + PENFS group as compared with the ST control ...

4. researchgate.net researchgate.net/publication/396883631_Percutaneous_Electrical_Nerve_Field_Stimulation_and_White_Matter_Integrity_in_a_Randomized_Trial_of_Veterans_With_Fibromyalgia

Percutaneous Electrical Nerve Field Stimulation and White ... Results: Immediately after one-shot treatment, the visual analog scale improved 1.53 units and the body surface score improved 3.06 units in the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06783504

Effect Of Percutaneous Electrical Nerve Field Stimulation ... The purpose of this study is to find out if we can stimulate the vagus nerve. The vagus nerve is a largely internal nerve that controls many bodily ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10869640/

Percutaneous Electrical Nerve Field Stimulation (PENFS) in ... Improvements in abdominal pain, nausea, and functional disability were sustained at 6-12 months and benefits in anxiety and catastrophizing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10545961/

Percutaneous electrical nerve field stimulation compared to ... Therapy with PENFS showed improvements in abdominal pain, nausea and disability while amitriptyline showed improvements in abdominal pain within 3 months of ...

8. ibstim.com ibstim.com/safety-profile/

Safety Profile for IB-Stim Safety of percutaneous electrical nerve field stimulation has also been reported in a separate study of over 1200 patients with no serious ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06415591?term=AREA%5BConditionSearch%5D(a%20field%20syndrome%20OR%20%22Armfield%20X-linked%20intellectual%20disability%20syndrome%22%20OR%20%22%20intellectual%20developmental%20disorder,%20X-linked,%20syndromic,%20Armfield%20type,%20X-linked%20recessive%22%20OR%20%22%20intellectual%20disability%20syndrome,%20X-linked,%20Armfield%20type%22%20OR%20%22%20mental%20retardation%20syndrome,%20X-linked,%20armfield%20type,%20X-linked%20recessive%22%20OR%20%22%20MRXSA%22%20OR%20%22%20syndromic%20X-linked%20intellectual%20disability%20Armfield%20type%22%20OR%20%22%20X-linked%20intellectual%20disability,%20Armfield%20type%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=8

Auricular Neuromodulation in Veterans With Fibromyalgia PENFS (percutaneous electrical nerve field stimulation) is an FDA-cleared ... The 24- week timepoint is chosen to evaluate longer term (6 months) pain outcomes ...

10. academic.oup.com academic.oup.com/painmedicine/article/12/9/1406/1899449

Safety and Efficacy of Vagus Nerve Stimulation in Fibromyalgia We performed an open-label Phase I/II trial to evaluate the safety and tolerability of vagus nerve stimulation (VNS) in patients with treatment-resistant ...