Transcranial pulsed electromagnetic fields for multiple chemical sensitivity: study protocol for a randomized, double-blind, placebo-controlled trial

Trials

Jesper Elberling¹  Karl Bang Christensen²  Lars Arendt-Nielsen³  Sine Skovbjerg¹  Marie Thi Dao Tran¹ 

[1] The Danish Research Centre for Chemical Sensitivities, Department of Dermato-Allergology, Copenhagen University Hospital Gentofte, Ledreborg Allé 40, 2. th., DK-2820 Gentofte, Denmark;Section of Biostatistics, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, DK-1014 Copenhagen K, Denmark;Center for Sensory–Motor Interaction, Department of Health Science and Technology, Aalborg University, Frederik Bajers Vej 7 D3, DK-9220 Aalborg, Denmark

关键词: Randomized controlled trial;    Re5 independent system;    Re5 therapy;    Pulsed electromagnetic fields;    Multiple chemical sensitivity;   

Others  :  1093232
DOI  :  10.1186/1745-6215-14-256

 received in 2013-04-23, accepted in 2013-08-05,  发布年份 2013

【 摘 要 】

Background

Multiple chemical sensitivity (MCS) is a chronic condition of unknown etiology. MCS is characterized by recurrent nonspecific symptoms from multiple organ systems in response to chemical exposures in concentrations that are normally tolerated by the majority of the population. The symptoms may have severe impact on patients’ lives, but an evidence-based treatment for the condition is nonexisting. The pathophysiology is unclarified, but several indicators point towards abnormal processing of sensory signals in the central nervous system. Pulsed electromagnetic fields (PEMF) offer a promising new treatment for refractory depression and can be targeted at the brain, thereby activating biochemical cell processes.

Methods/Design

In a parallel, randomized, double-blind, placebo-controlled trial conducted at the Danish Research Centre for Chemical Sensitivities, the effects of PEMF in MCS patients will be assessed using the Re5 Independent System. Based on sample size estimation, 40 participants will be randomized to either PEMF therapy or placebo. The allocation sequence will be generated by computer. All involved parties (that is, participants, investigators, the research nurse, and the statistician) will be blinded to group allocation. The participants will receive PEMF therapy or placebo applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks. Outcomes will be measured at baseline, once weekly during treatment, post treatment, and at 2.5-month and 4.5-month follow-up according to a predefined timetable. The primary outcome will be a measurement of the impact of MCS on everyday life. The secondary outcomes will be measurements of MCS symptoms, psychological distress (stress, anxiety or depressive symptoms), capsaicin-induced secondary punctate hyperalgesia, immunological markers in serum, and quality of life.

Discussion

This trial will assess the effects of PEMF therapy for MCS. Currently, there is no treatment with a documented effect on MCS, and in terms of healthcare there is very little to offer these patients. There is thus a great need for well-conducted randomized trials aimed at assessing possible treatment effects. A positive outcome will pave the way for improved healthcare and understanding of this very disabling and overlooked condition.

Trial registration

ClinicalTrials.gov, NCT01834781

【 授权许可】

   
2013 Tran et al.; licensee BioMed Central Ltd.

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