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

Mayo Clinic

Status: Completed

Conditions: Fibromyalgia; Fibromyalgia Syndrome

Treatments: Other: Transdermal Magnesium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01968772

13-001413

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with fibromyalgia at Mayo Clinic Rochester's Fibromyalgia Clinic
• Postmenopausal women (no menstrual period for 1 year or more)
• Women age 40-70 that have had a hysterectomy
• Willing to travel to Mayo Clinic Rochester for the initial instruction visit
• Able to apply the transdermal magnesium chloride as directed
• Able to complete the questionnaires and daily diary
• Able and willing to give informed consent
• Able to speak, write and understand English

Exclusion criteria

• Patients on dialysis
• Individuals who decline to participate in the study
• Diagnoses of bipolar disorder, schizophrenia or dementia
• Patients with myasthenia gravis and myasthenic syndromes
• Patients on magnesium supplements

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Transdermal Magnesium Chloride

Other group

Description:

This is a clear, odorless liquid that dries rapidly on the skin and leaves no oily residue. Its ingredients are water, magnesium chloride, and a proprietary blend of less than two-tenths of 1% trace minerals (Boron, Selenium, and Manganese).

Treatment:

Other: Transdermal Magnesium Chloride