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Fibromyalgia Investigational Therapies include Electrical Stimulation and Hot Water Immersion


Debilitating pain from fibromyalgia

Fibromyalgia is a common neurological condition that is characterized by chronic pain and tenderness lasting more than three months. The widespread pain may come and go and is not localized to one area of the body. It is most commonly seen in women although it may affect men and usually starts in mid-adulthood.

The disease is often accompanied by other symptoms that impair quality of life such as severe fatigue, sleep disturbances, and cognitive dysfunction. Patients may also suffer from depression, anxiety, headaches, and digestive problems such as inflammatory bowel syndrome (IBS) and gastroesophageal reflux disease (GERD).

Fibromyalgia is not an autoimmune disease nor is it inflammation-based, and laboratory testing and physical examination results are usually normal. The pathogenesis of fibromyalgia remains unclear, but studies suggest the involvement of the nervous system. It has been found that the risk for fibromyalgia increases if you have an underlying rheumatic disease (conditions affecting the muscles, bones, and joints) such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or lupus.

Research has demonstrated a genetic predisposition to fibromyalgia although genes alone are not causative. It is often found that certain triggers may provoke the development of fibromyalgia. These triggers may involve physical injury, prior illness, or emotional and mental trauma.

Diagnosing Fibromyalgia

The wide range of possible symptoms along with progressive changes makes fibromyalgia a condition difficult to diagnose. Diagnosis is primarily symptom-based as there are no specific tests that can detect this disease. However, some lab tests or x-rays may be required to rule out other health conditions. The existence of certain comorbid disorders such as rheumatic disease, IBS, mood disorders, and migraine may help in the diagnosis.

The doctor usually assesses the patient’s medical history to identify the criteria for fibromyalgia and performs physical examination (often involving joint evaluation and neurological examination) to check if symptoms may be due to other contributing causes. In the case of suspected fibromyalgia, patient screening is begun by requesting the patient to fill in self-report type measures which may include assessment of symptoms and a body pain diagram.

The criteria required for a fibromyalgia diagnosis are:
  • Widespread pain and other symptoms (fatigue, waking up unrefreshed, and cognitive difficulties, etc.) over the past week.
  • Symptoms at a similar level lasting a minimum of three months.
  • Absence of other health conditions that may explain chronic pain and other symptoms.

Management of Fibromyalgia

Drug Therapies
Although fibromyalgia has an unclear etiology, and no specific therapy, many pharmacological and non-pharmacological treatments are available. The management of fibromyalgia involves a long-term strategy that aims at improving function and relieving symptoms and not just minimizing pain. Fibromyalgia patients usually require multiple drugs to relieve their symptoms and existing comorbidities.

In the United States, there are currently three main drugs that have been approved for fibromyalgia therapy. Two of the drugs, milnacipran (Savella) and duloxetine (Cympbalta), increase the activity of brain chemicals (neurotransmitters) that have an inhibitory role on pain. The other approved drug, Pregabalin (Lyrica) works by reducing the activity of neurotransmitters involved in facilitating pain transmission.

Other drugs such as cyclobenzaprine, gabapentin, amitriptyline, and fluoxetine have shown positive results in clinical trials and may also be used for fibromyalgia, although not approved by the FDA for this indication. They have also shown to improve sleep in patients with sleep-related symptoms. It is highly recommended that patients avoid opioid narcotics as research has shown that they are ineffective in treating fibromyalgia and may increase pain severity.

Unfortunately, over-the-counter medications such as nonsteroidal anti-inflammatory drugs (NSAIDS) and acetaminophen (Tylenol) are ineffective in relieving fibromyalgia pain and sleeping medicines such as zolpidem are not recommended.

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Non-drug Therapies
Non-pharmacological therapies should be an important element in the treatment strategy for patients with fibromyalgia. The most effective non-drug treatments are patient education, physical exercise, sleep hygiene, and cognitive behavioral therapy (CBT). Aerobic exercise has been shown to be the most effective, starting with low-intensity exercises such as walking and swimming, and increasing the intensity a few times a week. It is important that exercise is continued as it has been associated with maintaining fibromyalgia symptom improvements.

Cognitive behavioral therapy is based on the understanding that certain behaviors and thoughts may alter pain perception and other symptoms. It can help patients learn skills that reduce the perception of pain. Other alternative treatments such as massage therapy and acupuncture may be useful but have not been well studied for fibromyalgia therapy.

Investigational Therapies for Fibromyalgia

One possible therapy for fibromyalgia is cranial electrical stimulation or CES. It involves the delivery of low-intensity electric currents via ear clip electrodes. CES is FDA-approved to be utilized in the military and veteran affairs system. It is currently under clinical trial in the United States for its therapeutic use in fibromyalgia.

Another investigational therapy for fibromyalgia is heat therapy by hot water immersion (using a hot tub). Heat therapy has been historically used for its presumed benefits for pain relief and cardiovascular disease. Studies have demonstrated improvements in rheumatic patients who have performed heat therapy. The therapeutic potential of heat therapy for fibromyalgia is presently under clinical trial in the United States.

The Sana Device, based on the delivery of Audio-Visual Stimulation (AVS) via a facial mask, is currently undergoing clinical trial in the United States. It delivers pulses of light and sound at different frequencies. The idea behind AVS stimulation for the treatment of fibromyalgia occurred after studies showed that AVS reduces high-frequency and increases low-frequency brain activity leading to improved sleep and reduced arousal along with potential pain reduction.

An additional therapy for fibromyalgia is potentially transcranial direct current stimulation (tDCS), which stimulates the endogenous pain regulation system leading to increased pain relief. Currently, the usage of tDCS for fibromyalgia therapy is under clinical trial in the US. The premise of this therapy was proposed after evidence demonstrated that fibromyalgia pain is likely related to impaired endogenous pain regulation and that pain inhibitory pathways are shown to be affected in patients with fibromyalgia.

-           Thorpe J, Shum B, Moore RA, Wiffen PJ, Gilron I. Combination pharmacotherapy for the treatment of fibromyalgia in adults. Cochrane Database Syst Rev. 2018;2(2):CD010585. Published 2018 Feb 19. doi:10.1002/14651858.CD010585.pub2
-           Bazzichi L, Giacomelli C, Consensi A, et al. One year in review 2020: fibromyalgia. Clin Exp Rheumatol. 2020;38 Suppl 123(1):3-8.
-           Arnold LM, Gebke KB, Choy EH. Fibromyalgia: management strategies for primary care providers. Int J Clin Pract. 2016;70(2):99-112. doi:10.1111/ijcp.12757
-           Fibromyalgia. Rheumatology.org. Published 2010. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Fibromyalgia
-           Tang HY, Vitiello MV, Perlis M, Mao JJ, Riegel B. A pilot study of audio-visual stimulation as a self-care treatment for insomnia in adults with insomnia and chronic pain. Appl Psychophysiol Biofeedback. 2014;39(3-4):219-225. doi:10.1007/s10484-014-9263-8
-           Gilula MF. Cranial electrotherapy stimulation and fibromyalgia. Expert Rev Med Devices. 2007;4(4):489-495. doi:10.1586/17434440.4.4.489

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