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

Fibromyalgia Clinical Trial

Official title:

Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968772
• Other study ID #: 13-001413
• Status: Completed
• Phase: N/A
• First received: April 4, 2013
• Last updated: December 23, 2014
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Magnesium Direct

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. Epub 2003 Dec 20. — View Citation

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. — View Citation

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. — View Citation

Clauw D, Ward K, Katz P, Rajan S. Muscle intracellular magnesium levels with pain tolerance in fibromyalgia (FM). Arthritis Rheumat. 1994;S213:324.

Eisinger J, Zakarian H, Pouly E, Plantamura A, Ayavou T. Protein peroxidation, magnesium deficiency and fibromyalgia. Magnes Res. 1996 Dec;9(4):313-6. — View Citation

Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004 Nov 17;292(19):2388-95. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Wolfe F, Cathey MA. Prevalence of primary and secondary fibrositis. J Rheumatol. 1983 Dec;10(6):965-8. — View Citation

Wolfe F, Cathey MA. The epidemiology of tender points: a prospective study of 1520 patients. J Rheumatol. 1985 Dec;12(6):1164-8. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No