Trial record 2 of 468 for:    "Fibromyalgia"

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Magnesium Direct
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01968772
First received: April 4, 2013
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 Intervention
Fibromyalgia
Fibromyalgia Syndrome
Other: Transdermal Magnesium Chloride

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

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. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968772

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Magnesium Direct
Investigators
Principal Investigator: Dietlind L. Wahner-Roedler, MD Mayo Clinic
  More Information

Publications:

Responsible Party: Dietlind Wahner-Roedler, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01968772     History of Changes
Other Study ID Numbers: 13-001413
Study First Received: April 4, 2013
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Fibromyalgia
Fibromyalgia Syndrome
Magnesium Chloride
Transdermal Magnesium Chloride

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014