Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia
NCT ID: NCT01968772
Last Updated: 2014-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2013-10-31
2014-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
70 Years
FEMALE
No
Sponsors
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Magnesium Direct
UNKNOWN
Mayo Clinic
OTHER
Responsible Party
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Dietlind Wahner-Roedler
MD
Principal Investigators
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Dietlind L. Wahner-Roedler, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004 Nov 17;292(19):2388-95. doi: 10.1001/jama.292.19.2388.
Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
Wolfe F, Cathey MA. Prevalence of primary and secondary fibrositis. J Rheumatol. 1983 Dec;10(6):965-8.
Wolfe F, Cathey MA. The epidemiology of tender points: a prospective study of 1520 patients. J Rheumatol. 1985 Dec;12(6):1164-8.
Staud R, Vierck CJ, Cannon RL, Mauderli AP, Price DD. Abnormal sensitization and temporal summation of second pain (wind-up) in patients with fibromyalgia syndrome. Pain. 2001 Mar;91(1-2):165-75. doi: 10.1016/s0304-3959(00)00432-2.
Banic B, Petersen-Felix S, Andersen OK, Radanov BP, Villiger PM, Arendt-Nielsen L, Curatolo M. Evidence for spinal cord hypersensitivity in chronic pain after whiplash injury and in fibromyalgia. Pain. 2004 Jan;107(1-2):7-15. doi: 10.1016/j.pain.2003.05.001.
Ali M, Ali O. Fibromyalgia: An oxidative-dysoxygenative disorder (ODD). J Integr Med. 1999;3:17-37.
Bagis S, Tamer L, Sahin G, Bilgin R, Guler H, Ercan B, Erdogan C. Free radicals and antioxidants in primary fibromyalgia: an oxidative stress disorder? Rheumatol Int. 2005 Apr;25(3):188-90. doi: 10.1007/s00296-003-0427-8. Epub 2003 Dec 20.
Chung CP, Titova D, Oeser A, Randels M, Avalos I, Milne GL, Morrow JD, Stein CM. Oxidative stress in fibromyalgia and its relationship to symptoms. Clin Rheumatol. 2009 Apr;28(4):435-8. doi: 10.1007/s10067-008-1072-0. Epub 2008 Dec 17.
Iqbal R, Mughal MS, Arshad N, Arshad M. Pathophysiology and antioxidant status of patients with fibromyalgia. Rheumatol Int. 2011 Feb;31(2):149-52. doi: 10.1007/s00296-010-1470-x. Epub 2010 Apr 8.
London M. The role of magnesium in fibromyalgia. 1994. http://web.mit.edu/london/www.magnesium.html
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.
Eisinger J, Zakarian H, Pouly E, Plantamura A, Ayavou T. Protein peroxidation, magnesium deficiency and fibromyalgia. Magnes Res. 1996 Dec;9(4):313-6.
Clauw D, Ward K, Katz P, Rajan S. Muscle intracellular magnesium levels with pain tolerance in fibromyalgia (FM). Arthritis Rheumat. 1994;S213:324.
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.
Other Identifiers
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13-001413
Identifier Type: -
Identifier Source: org_study_id