Clinical trial NCT01968772: Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia
Official title: Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Fibromyalgia Syndrome
Keywords: Fibromyalgia
Fibromyalgia Syndrome
Magnesium Chloride
Transdermal Magnesium Chloride
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Magnesium Direct
First posted: 2013-10-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 28 Days
Secondary outcomes:
measure: 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.
timeFrame: 28 Days
measure: 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.
timeFrame: 28 Days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dietlind L. Wahner-Roedler, MD
role: PRINCIPAL_INVESTIGATOR
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