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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01968772

Collaborator

Magnesium Direct (Other)

Enrollment

Location

Arm

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Fibromyalgia Syndrome	Other: Transdermal Magnesium Chloride	N/A

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.

Study Design

Study Type:

Interventional

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 :

Oct 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).	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.

Arm

Intervention/Treatment

Other: 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).

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.

Outcome Measures

Primary Outcome Measures

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. [28 Days]

Secondary Outcome Measures

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. [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. [28 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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