Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia
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ClinicalTrials.gov Identifier: NCT01968772 |
Recruitment Status :
Completed
First Posted : October 24, 2013
Last Update Posted : December 24, 2014
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Condition or disease | Intervention/treatment | Phase |
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Fibromyalgia Fibromyalgia Syndrome | Other: Transdermal Magnesium Chloride | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia - A Pilot Study |
Study Start Date : | October 2013 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
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Transdermal Magnesium Chloride
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).
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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. |
- Change from baseline to end of study on quality of life as documented by the Revised Fibromyalgia Impact Questionnaire (FIQR) in women with fibromyalgia after applying a transdermal magnesium chloride solution to their arms and legs 2 times daily. [ Time Frame: 28 Days ]
- Change from baseline to study end on quality of life as documented by the SF-36v2 Health Survey in women with fibromyalgia after applying a transdermal magnesium chloride solution to their extremities 2 times daily. [ Time Frame: 28 Days ]
- Change from baseline to study end on quality of life as documented by the Quality of Life Analog Scale (QOL Analog Scale) in women with fibromyalgia after applying a transdermal magnesium chloride solution to their extremities 2 times daily. [ Time Frame: 28 Days ]

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968772
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Dietlind L. Wahner-Roedler, MD | Mayo Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dietlind Wahner-Roedler, MD, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT01968772 |
Other Study ID Numbers: |
13-001413 |
First Posted: | October 24, 2013 Key Record Dates |
Last Update Posted: | December 24, 2014 |
Last Verified: | December 2014 |
Fibromyalgia Fibromyalgia Syndrome Magnesium Chloride Transdermal Magnesium Chloride |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |