NCT01968772

Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia

Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia
• Fibromyalgia Syndrome

Interventions

Type	Name	Description
OTHER	Transdermal Magnesium Chloride	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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2013-10-24
• Last updated: 2014-12-24

Locations

1 site across 1 country: United States