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

NCT01968772 | Completed

• 1 other identifier: 13-001413
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia; Fibromyalgia Syndrome

Keywords

Fibromyalgia; Fibromyalgia Syndrome; Magnesium Chloride; Transdermal Magnesium Chloride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Transdermal Magnesium Chloride

OTHER

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

Interventions

Transdermal Magnesium Chloride OTHER

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.

Transdermal Magnesium Chloride

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Magnesium Direct: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (15)

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  PMID: 11240089 BACKGROUND

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  PMID: 14715383 BACKGROUND

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  BACKGROUND

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  PMID: 20376669 BACKGROUND

• London M. The role of magnesium in fibromyalgia. 1994. http://web.mit.edu/london/www.magnesium.html

  BACKGROUND

• Magaldi M, Moltoni L, Biasi G, Marcolongo R. [Changes in intracellular calcium and magnesium ions in the physiopathology of the fybromyalgia syndrome]. Minerva Med. 2000 Jul-Aug;91(7-8):137-40. Italian.

  PMID: 11155461 BACKGROUND

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  PMID: 9247880 BACKGROUND

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  BACKGROUND

• Engen DJ, McAllister SJ, Whipple MO, Cha SS, Dion LJ, Vincent A, Bauer BA, Wahner-Roedler DL. Effects of transdermal magnesium chloride on quality of life for patients with fibromyalgia: a feasibility study. J Integr Med. 2015 Sep;13(5):306-13. doi: 10.1016/S2095-4964(15)60195-9.

  PMID: 26343101 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Dietlind L. Wahner-Roedler, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: October 24, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

US (1)