APRIL 16, 2025
LAS VEGAS—Currently, there are only three FDA-approved drugs to treat fibromyalgia: pregabalin, duloxetine hydrochloride and milnacipran (Savella). These and other off-label drugs used to treat fibromyalgia have adverse effects, which can make them intolerable for people struggling with the disease.
“Fibromyalgia patients tend to have multiple chemical sensitivities, so they really don’t tolerate most medication as well. Finding something that works for them that doesn’t
LAS VEGAS—Currently, there are only three FDA-approved drugs to treat fibromyalgia: pregabalin, duloxetine hydrochloride and milnacipran (Savella). These and other off-label drugs used to treat fibromyalgia have adverse effects, which can make them intolerable for people struggling with the disease.
“Fibromyalgia patients tend to have multiple chemical sensitivities, so they really don’t tolerate most medication as well. Finding something that works for them that doesn’t involve taking a drug is really pretty important,” said Anna Woodbury, MD, MSc, an interventional pain physician and associate professor in the Department of Anesthesiology at the Emory University School of Medicine, in Atlanta.
A main focus of Woodbury’s work is the use of neuromodulation for the nonopioid management of pain. At ASRA Pain Medicine’s 2024 Fall Pain Medicine Meeting, Woodbury and her colleagues presented a study on the use of cranial electrotherapy stimulation (CES) for fibromyalgia pain and function.
Research in Electrical Stimulation
Originally approved as treatment for insomnia or anxiety, CES has been explored to treat a number of medical conditions during the past two decades, including depression, pain and fibromyalgia. Studies indicate that several forms of neuromodulation may be effective in treating fibromyalgia. A recent meta-analysis showed that electrical neuromodulation, including transcranial direct current stimulation, CES and repetitive transcranial magnetic stimulation, resulted in significant improvements in pain, depression and functioning in patients with fibromyalgia (Gen Hosp Psychiatry 2024;87:103-123).
In their randomized, double-blind trial presented at ASRA, Woodbury’s team used CES microcurrent electrical therapy to determine its effect on pain, function, sleep, mood, fatigue, global health and other outcomes in an intention-to treat analysis of 33 patients with fibromyalgia (17 active treatment; 16 sham treatment). Participants were asked to wear the device for 60 minutes daily during a period of 12 weeks.
Effects on Pain and Activity
Participants in both groups reported reductions in the Defense and Veterans Pain Rating Scale pain scores and pain interference at 12 weeks. However, only those in the CES group demonstrated increased function on resting-state functional connectivity magnetic resonance imaging.
“We were most likely underdosing the true group to preserve blinding, so there wasn’t a significant difference in clinical outcomes between the groups. But if you follow them at six weeks and at 12 weeks, both groups were significantly better than when they started, and both of them met the standard threshold for what is considered the minimally, clinically important difference in pain, which is about a 2-point decrease in pain scores,” Woodbury said.
The 2-point reduction in pain scores may suggest a meditative effect of the daily prescribed protocol.
The decreases in pain interference measures indicated that there was less impairment in activity, mood and sleep, and less stress. In a separate analysis, Woodbury’s team also found a reduction in fatigue.
The investigators observed enhanced connectivity between the cerebellar seed and regions implicated in visual processing and memory with CES. The cerebellum is emerging as an important player in pain processing, and the cerebellar lobule 7b plays a significant role in different dimensions of pain perception. The observed connectivity implicates multimodal processing, and suggests an interplay between the cerebellum and the sensory and the cognitive regions that CES may influence.
“If you look at some of the meditation and brain imaging studies, people who meditate are often using guided imagery or visualization and accessing the visual networks in meditation,” said Woodbury. “The cerebellum is specifically involved in emotion and pain processing, so changes in connectivity to this seed were not a surprise to us. But the vision and language processing networks were surprisingly significant nodes. There are some studies that show that people who are not as good at describing the type of pain they’re experiencing tend to have higher pain severity, so that language processing may be part of it.”
Woodbury hypothesized that neuroplasticity is involved.
“It’s a positive effect but since we were kind of underdosing the treatment group, maybe it didn’t translate as well to a clinical effect,” she explained.
Patients ‘Love’ It
Woodbury recounted many people who benefited from CES for conditions ranging from pain to insomnia.
One patient began hyperventilating in anticipation of a knee injection, but after applying the device—which he had previously used for insomnia—had a “look of bliss” on his face and was able to tolerate the procedure uneventfully, Woodbury recalled.
Another one of her patients fell off a bridge and became dependent on 100 mg of oxycodone per day. Woodbury was able to titrate him off the oxycodone and then he started using the CES device.
“I didn’t hear from him for four years, and I wasn’t sure what happened to him. He finally called the hospital line and they forwarded a message to me,” she said.
“He was like, ’Hey, you know this message is for Dr. Woodbury. I hope everything’s going well with her. I’m doing well over here, but my alpha-stim ear clips broke—was just wondering if she could send me some new ones.’”
Although Woodbury stressed that follow-up was integral to patient care, she concedes that CES poses minimal risks, which can include headache or mild skin irritation in some patients.
Unlike some devices that are procured on a subscription basis or rental, CES is very affordable and costs about $800. Although it is best to get a prescription, units are available on eBay for purchase.
Looking forward, Woodbury wants to titrate up the intensity of CES in study participants and examine its use in different types of pain.
Experts See Potential
Others in the field, including Maged N. Guirguis, MD, the chair of the Interventional Pain Management Department at Ochsner Health, in New Orleans, were impressed with the trial.
“The study is promising, although the sample size was quite small considering the frequency of fibromyalgia syndrome. The lack of statistical significance between the treatment arm and the placebo indicates that further research is necessary,” he said.
“A fascinating outcome was the changes observed in functional MRI, as this was a subjective measure. This finding is very encouraging and suggests the need for a larger randomized, double-blind, controlled trial following this pilot study. The new trial should include more participants and be extended over six to 12 months to reduce the effects of placebo,” Dr. Guirguis said. “Overall, it was a very good trial.”
—Naveed Saleh, MD, MS
