Clinical trial NCT01834781: Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity
Official title: Transcranial Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity: a Study Protocol for a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chemical Sensitivity
Keywords: multiple chemical sensitivity, re5 therapy, pulsed electromagnetic fields
Lead sponsor: The Danish Research Centre for Chemical Sensitivities
Sponsor class: OTHER
Collaborators: name: Aage Bangs Fond
First posted: 2013-04-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pulsed electromagnetic fields(PEMF) is effective in the treatment of multiple chemical sensitivity in terms of life impact, symptoms, psychological distress, markers of central sensitization and the immune system, and quality of life.


Eligibility criteria: Inclusion Criteria:

* Lacour's criteria for multiple chemical sensitivity
* Lifestyle or functional impairments that score ≥ 35 on the Life Impact scale of the Quick Environmental Exposure and Sensitivity Inventory
* Signed informed consent

Exclusion Criteria:

* previous PEMF therapy
* psychosis or a comparable disorder
* epilepsy
* cerebral tumours
* leukaemia or malignancies in the head or neck region
* having a pacemaker or other active implants
* pregnancy or nursing
* unreliable contraception
* drug or alcohol abuse
* a pending application or intentions to apply for early retirement
* initiation of pharmacological treatment which have not steadied
* participation in another research study

Primary outcomes:
measure: Change from baseline in Life Impact Scale (Quick Environmental Exposure and Sensitivity Inventory)
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Secondary outcomes:
measure: Change from baseline in Symptom Severity Scale (Quick Environmental Exposure and Sensitivity Inventory)
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in Chemical Intolerance Scale (Quick Environmental Exposure and Sensitivity Inventory)
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in Sheehan Disability Scale
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in individual self-selected tasks
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in noise sensitivity
timeFrame: Week 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in depression (Symptom Check List-92)
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in anxiety (Symptom Check List-92)
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in somatization (Symptom Check List-92)
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in 6-item Hamiltons Depression Scale
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in Perceived Stress Scale
timeFrame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
measure: Change from baseline in World Health Organization Quality Of Life Brief version
timeFrame: Week 6 and 4½ month follow-ups
measure: Change from baseline in capsaicin-induced secondary punctate hyperalgesia
timeFrame: Week 6
measure: Change from baseline in immunological markers in serum
timeFrame: Week 6
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: The Danish Research Centre for Chemical Sensitivities
Study officials:
References:
citation: Tran MT, Skovbjerg S, Arendt-Nielsen L, Christensen KB, Elberling J. Transcranial pulsed electromagnetic fields for multiple chemical sensitivity: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2013 Aug 16;14:256. doi: 10.1186/1745-6215-14-256.