This time of year is known for graduations, springtime weather and outdoor activities, but for many people living with fibromyalgia that might not be the case. Fibromyalgia is a chronic pain condition that causes widespread pain throughout the body. The condition impacts approximately 3% of the U.S. population or around 10 million people. Despite the prevalence, it is known as the “garbage can condition” due to the difficulty in diagnosing the condition. Typically, a diagnosis is warranted after other options have been eliminated. According to the CDC there is no known cause or objective laboratory test or biomarkers of fibromyalgia.
Although the CDC classifies fibromyalgia as a type of arthritis, the condition may be presented along with other conditions in particular lupus. Nearly 90% of those diagnosed with fibro are women. The American College of Rheumatology developed clinical diagnostic criteria in 1990 as follows: a) history of widespread pain lasting more than months and b) the presence of pain in 11 of the 18 point sites within the four quadrants of the body. Symptoms may also include fatigue, difficulty sleeping, anxiety, depression, cognitive difficulties (brain fog) or sensory sensitivity.
The current first line treatments are medications. There are three approved by the FDA: Lyrica, Cymbalta and Savella. Still these do not provide overall condition relief. Medications for other conditions may also be prescribed such as Ketamine or Natrexone. There are an array of pharmaceuticals prescribed to help with the symptoms of fibro. Still, there is no single treatment. There is also an array of non-pharmaceutical treatments such as physical therapy, meditation, yoga, nutrition, supplements, massage, or even acupuncture. Pain specialty clinicians and advocacy organizations advise the creation of a plan that includes individualized treatments along with a maintenance schedule to help guide the self-care.
In the area of neurotechnology there is currently one known regulatory approved devices for the treatment of fibromyalgia. This therapy is a form of thermal exchange heat therapy for the hand and wrist. Light pressures are applied in a vacuum chamber to increase the core body temperature to induce relaxation. This change in body temperature may alter the sympathetic nervous system to reduce pain sensations associated with fibromyalgia. The small 22-person study was performed in San Diego over a four week period. The treatment group experienced a 40% widespread reduction of pain as well as a reduction of the average tender point counts. The device used is called the Avacen 100 which is currently Health Canada and CE Mark approved for symptoms related to fibromyalgia and FDA cleared for pain symptoms associated with arthritis. The device is available through Avacen Medical.
Despite the limited availability of neurotech targeting fibrmyalgia, the exciting news is the breadth of neuromodulation modalities in clinical trials with commercialization efforts. If successful, these neuromodulation treatments could offer a means to mitigate the symptoms related to fibromyalgia. There are also early stage clinical trials that show promise. Some of the modalities include cranial electrotherapy, audiovisual therapy, trigeminal nerve stimulation, peripheral nerve stimulation, and even vibrotactile stimulation. Here we will summary these technologies and more.
Fibromyalgia clinical trials with commercial partners
Cranial/Cortical Electrotherapy Stimulation (CES)
CES is a mild electrical stimulation to the brain. It is believed to impact the neuro-transmitters in the brain. In a study published in 2001, 60 participants with fibromyalgia endured 3 weeks of CES treatment for one hour per day. They were segmented in to the treatment group, the sham group and an in-line control group. The outcomes were focused on sleep quality, anxiety and depression all related to fibromyalgia. At the end, the CES treatment group had significant improvements in anxiety scores, higher sleep quality scores, lower pain scores and fatigue scores plus higher well-being scores. The study was published in the Journal of Clinical Rheumatology and was sponsored by Alpha-Stim. Here is a link to that published study.
Trigeminal nerve stimulation (TNS)
This is a non-invasive or surface stimulation modality that was first developed and commercialiated to treat migraine headaches (Cefaly) and for ADHD(NeuroSigma). Presented as external devices, they include a small electrode placed on the lower forehead between the eyes. This treatment delivers electrical pulses to the trigeminal nerve nucleus that connects to key structures in the brain. Neurotransmitters, natural chemical substances that deliver messages between neurons, are released with this stimulation treatment. TNS devices are currently in clinical trials to treat fibromyalgia. This clinical trial has been completed but the results have yet to be posted or published. The study was sponsored by Cefaly and clinical trial listing can be found here.
Transcutaneous Electrical Nerve Stimulation (TENS)
Transcutaneous electrical nerve stimulation translates to stimulation that is delivered to the peripheral nerves through the depth of the skin. This modality has been and still is used for many applications, including pain relief. The devices mainly consist of a small battery powered unit with sticky electrodes connected to it. Many of these devices are available through a physician or over the counter. A sham-controlled, double-blind, randomized clinical trial involving 300 participants living with fibromyalgia was recently published. In this study, researchers were investigating whether TENS along with activity would improve movement evoked pain in women living with fibro. After 4 weeks of home use, the active TENS group had significant improvements in fatigue and global impressions of change. The published study may be found here.
A follow-on study is now underway to collect real-world data. The study involves 600 participants and will investigate whether or not TENS coupled with physical therapy will improve pain scores as well as a reduction in medication use. Funded through the NIH HEAL (Helping to End Addiction Long-term) initiative with the corporate sponsor, NeuroMetrix. The Quell device, a small wearable device placed below the knee, will be used in the study and will be lead by Drs. Kathleen Sluka from the University of Iowa and Leslie Crofford of Vanderbilt University. Here is the trial announcement.
Audio Visual Therapy (AVS)
Audiovisual stimulation (AVS) is another therapeutic modality being investigated to treat those living with fibromyalgia. Contrary to the previously mentioned modalities, AVS delivers stimulation through the use of gentle, coordinated pulses of light and sound at various intensities and frequencies, respectively. Treatment is delivered through a face-worn mask and headphones in 16-minute sessions. A randomized controlled trial, based out of Duke University, is an interventional study involving 120 participants living with fibromyalgia. The trial may be found here. Sana Health is the company sponsor. AVS is also being investigated for the treatment of chronic neuropathic pain.
The promising fact of these clinical studies is that there is a commercial sponsor. If successful, the devices and modalities used in these studies may lead to accelerated availability.
Other Areas of Investigation
There are many other stimulation modalities being investigated to treat fibromyaligia that are still in early-stages of development and exploration. Here are some examples of minimally-invasive or non-invasive areas of discovery to treat fibro. Some of the studies have been peer-reviewed and published, but they are not commercially available at this time specifically for the treatment of fibro.
Occipital Nerve Stimulation involves a device placed at the base of the skull on the back of the neck. This peripheral nerve stimulation activates the occipital nerve controlling sensation on the head and neck. Here is the publication of a small 40 participant randomized controlled study using this modality with promising results for improvements of fibro pain, daily activities and quality of life.
Vagus Nerve Stimulation is stimulation of the 12th cranial nerve, the longest and most complex of this bundle of nerves. This nerve transmits information to and from the brain to both tissues and organs throughout the body. Several studies have been completed investigating non-invasive stimulation of the auricular branch of the vagus nerve. This area is the great auricular branch of the vagus nerve which has its origins at the C2 & 3 levels of the spinal cord and runs up the neck on the left side. It controls many sensory nerves for the neck, face and head. The results for this modality of stimulation alone are not compelling but worth further investigation. Here is a study conducted in Georgia with veterans living with fibro. This is another study conducted in Turkey.
Transcranial Direct Current Stimulation (tDCS) is a modality in the form of a wearable brain stimulator. It delivers low electrical current to the scalp and applies a positive and negative current through electrodes. It is believed to alter neuron firing in order to augment synaptic plasticity of the brain. It is often used in combination with training to improve retention, such as motor rehabilitation. There are a variety of medical applications being explored including pain. It is also available as a wellness device to accelerate learning, induce relaxation and aid in meditation. A study conducted in South Korea demonstrated a reduction in pain scores of the participants. There is also a multi-center study being conducted to address pain relief for those living with Fibromyalgia.
Repetitive Transcranial Magnetic Stimulation (rTMS) refers to stimulation that delivers electrical pulses to the brain through a magnetic coil held over the head. The adjusted waveform pattern is sent through the skull to the brain. When the pulses are sent in a rapid sequence, it is called repetitive TMS. The treatment can potentially change brain function to treat neurological conditions. It is currently being administered for conditions such as depression, obsessive compulsive disorder and certain forms of chronic pain. The current evidence for using rTMS to treat fibromyalgia is mixed. This is a randomized controlled clinical trial conducted in France which found that rTMS is not effective for fibromyalgia. Alternatively, here is a randomized controlled trial conducted in Australia suggesting that rTMS is effective in treating fatigue related to fibro.
Vibrotactile Stimulation is a non-invasive neuromodulation technique which involves gentle vibrating stimulation to a variety of areas of the body, including the fingertips, brain and even the whole body. It is believed this modality provides somatosensory inputs to the human nervous system. One initial study involving 77 women living with fibromyalgia applied gentle vibrotactile whole body stimulation for 3 hours at night over a 3-week period. The stimulation was delivered through a specially designed mattress. The results were not universal to provide a clear conclusion but it may help with sleep quality.
Although there are currently no approved neurotechnology devices specifically for the treatment of fibromyalgia, there are some that may help with the symptoms related to the condition. There are also many promising treatments that are being investigated. The pipeline of development is encouraging for those living with fibromyalgia.
The devices mentioned in this feature are available in the free directory on the Neurotech Network Pain Management Information page. You will find a listing of the devices mentioned here, links to device sites and more. The content for this article was provided by Neurotech Network. Help us support these free resources with a donation.
Lichtbroun AS, Raicer MM, Smith RB. The treatment of fibromyalgia with cranial electrotherapy stimulation. J Clin Rheumatol. 2001 Apr;7(2):72–8; discussion 78. doi: 10.1097/00124743–200104000–00003. PMID: 17039098.
Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, Embree J, Merriwether EN, Geasland KM, Chimenti R, Williams JM, Golchha M, Crofford LJ, Sluka KA. Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial. Arthritis Rheumatol. 2020 May;72(5):824–836. doi: 10.1002/art.41170. Epub 2020 Mar 18. PMID: 31738014; PMCID: PMC7188591.
Plazier M, Ost J, Stassijns G, De Ridder D, Vanneste S. C2 Nerve Field Stimulation for the Treatment of Fibromyalgia: A Prospective, Double-blind, Randomized, Controlled Cross-over Study. Brain Stimul. 2015 Jul-Aug;8(4):751–7. doi: 10.1016/j.brs.2015.03.002. Epub 2015 Mar 16. PMID: 25910427.
Anna Woodbury, MD, Venkatagiri Krishnamurthy, PhD, Melat Gebre, MD, Vitaly Napadow, PhD, Corinne Bicknese, MD, Mofei Liu, MSPH, Joshua Lukemire, MS, Jerry Kalangara, MD, Xiangqin Cui, PhD, Ying Guo, PhD, Roman Sniecinski, MD, MSCR, Bruce Crosson, PhD, Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial, Pain Medicine, Volume 22, Issue 3, March 2021, Pages 715–726, https://doi.org/10.1093/pm/pnaa317
Nazlı Kutlu, Ali Veysel Özden, Hasan Kerem Alptekin, Jülide Öncü Alptekin, “The Impact of Auricular Vagus Nerve Stimulation on Pain and Life Quality in Patients with Fibromyalgia Syndrome”, BioMed Research International, vol. 2020, Article ID 8656218, 10 pages, 2020. https://doi.org/10.1155/2020/8656218
Kang, JH., Choi, SE., Park, DJ. et al. Effects of add-on transcranial direct current stimulation on pain in Korean patients with fibromyalgia. Sci Rep 10, 12114 (2020). https://doi.org/10.1038/s41598-020-69131-7.
Guinot M, Maindet C, Hodaj H, Hodaj E, Bachasson D, Baillieul S, Cracowski JL, Launois S. Effects of Repetitive Transcranial Magnetic Stimulation and Multicomponent Therapy in Patients With Fibromyalgia: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Mar;73(3):449–458. doi: 10.1002/acr.24118. PMID: 31785190.
Fitzgibbon BM, Hoy KE, Knox LA, Guymer EK, Littlejohn G, Elliot D, Wambeek LE, McQueen S, Elford KA, Lee SJ, Enticott PG, Fitzgerald PB. Evidence for the improvement of fatigue in fibromyalgia: A 4-week left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation randomized-controlled trial. Eur J Pain. 2018 Aug;22(7):1255–1267. doi: 10.1002/ejp.1213. Epub 2018 Apr 10. PMID: 29542208.