Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia
Condition: Fibromyalgia; Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      In this pilot study we propose to gather preliminary data on whether transdermal magnesium
      chloride can improve quality of life in patients with fibromyalgia. Forty women with
      fibromyalgia will be enrolled in this study. Participants will be asked to apply a topical
      solution of magnesium chloride on their extremities 3 times daily for 28 consecutive days.
      Three questionnaires measuring quality of life will be administered at baseline, at 2 weeks,
      and at 4 weeks (end of study).
    

Detailed description: 
      Fibromyalgia is a chronic pain syndrome with no known etiology. Fibromyalgia is generally
      diagnosed in patients reporting widespread musculoskeletal pain, and tenderness. In addition
      to widespread pain, fibromyalgia is also characterized by chronic fatigue, depression, sleep
      disturbances, and poor concentration. It has been reported that approximately 3.5% of women
      and 0.5% of men in the United States suffer from fibromyalgia. While the primary cause of
      fibromyalgia remains unclear, a growing body of evidence indicates that the widespread pain
      associated with fibromyalgia is due to abnormalities in the central nervous system. The pain
      threshold, both mechanical and thermal, in fibromyalgia sufferers are lowered such that it
      requires a lesser than normal stimulus to elicit pain.

      Recent reports suggest that fibromyalgia is an oxidative stress disorder and deficiency in
      trace elements and antioxidants play an important role in the development of fibromyalgia.
      Magnesium is a trace element that is important for many metabolic functions. It affects cell
      membrane permeability and electrical activity. The similarity in the clinical symptoms of
      fibromyalgia and magnesium deficiency along with the histopathological findings of tender
      points (such as hypoxia and adenosine triphosphate deficiency) raises the possibility that
      magnesium may play a role in fibromyalgia etiopathogenesis.

      In this pilot study we propose to explore the feasibility and ease of 2 times a day
      application of a topical solution to the arms and legs. We will also gather preliminary data
      on whether transdermal magnesium chloride can improve quality of life in women with
      fibromyalgia.
    

Intervention name(s): Transdermal Magnesium Chloride
Intervention type(s): Other
Intervention description(s): Each participant will be provided with a spray bottle containing a transdermal magnesium chloride solution and asked to apply 4 sprays per each arm and each leg 2 times a day as follows: pump 4 sprays into the palm of your hand and apply to each arm and each leg 2 times a day for a total of 32 sprays daily. Rub the contents of 4 sprays on one limb and repeat for each limb coating evenly.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Fibromyalgia; Fibromyalgia Syndrome; Magnesium Chloride; Transdermal Magnesium Chloride