Trial Using Non-Drug Headband Device to Treat the Pain of Fibromyalgia

A new trial using a non-drug treatment approach for fibromyalgia is underway by researchers at the University of Cincinnati (UC). The study will investigate the use of an electrode-emitting headband for its therapeutic effect on people with fibromyalgia, a chronic, painful and often debilitating condition. 

The headband, Cefaly, is FDA-approved for the treatment of migraine headaches. UC is the first center in the country to use the device in a trial for patients with fibromyalgia.

The device delivers electrodes of neuro-stimulation to limit the pain signals from the nerve center in the brain. In migraine sufferers, this may help reduce the frequency and severity of headaches, providing a non-drug alternative. 

Lesley Arnold, MD, a UC Health physician and professor of psychiatry and behavioral neuroscience at the University of Cincinnati, has conducted several studies looking at both medication and non-drug treatments for fibromyalgia. She says the trial will use the headband in patients with fibromyalgia to assess if the electrode therapy can have a similar effect. 

"People with fibromyalgia can experience widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, as well as memory issues, anxiety and depression,” says Arnold, who is also director of the Women’s Health Research Program and Fibromyalgia Treatment Program. "Research has shown that fibromyalgia amplifies painful sensations by affecting the way your brain processes pain signals. Symptoms sometimes begin after significant psychological stress or physical trauma, but can also gradually accumulate over time with no single triggering event.”

The trial is open to adults ages 18–65 with fibromyalgia. All enrolled participants will receive the devices, provided by Cefaly, the sponsor of the trial. Arnold cites no conflict of interest.

 "Since this is a pilot study, there is no placebo,” says Arnold. "Everyone’s going to get the treatment, and if people report some improvement, then they will go on to do the controlled studies, to try to get approval for it. It’s really a first step.”

Arnold, has begun using the device with patients in her clinic, but the trial will take up to 50 volunteers and will run through the year. For more information on the trial, contact Kerri Earles at 513-558-7104 or Kerri.earles@uc.edu