Transcranial Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity: a Study Protocol for a Randomized, Double-blind, Placebo-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Chemical Sensitivity
- Sponsor
- The Danish Research Centre for Chemical Sensitivities
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Change from baseline in Life Impact Scale (Quick Environmental Exposure and Sensitivity Inventory)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Change from baseline in Life Impact Scale (Quick Environmental Exposure and Sensitivity Inventory)
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
The Life Impact Scale is part of the Quick Environmental Exposure and Sensitivity Inventory (QEESI). The QEESI consists of five scales measuring different domains related to chemical sensitivities, i.e. commonly reported symptoms, chemical (inhalant) intolerances, other intolerances, life impact attributed to chemical intolerances, and on-going exposures from routinely used products (Masking Index). The Life Impact Scale consists of 10 items, where responses are rated on an 11 point scale ranging from "not at all a problem" (0) to "disabling symptoms" (10)), resulting in a score range from 0 to 100.
Secondary Outcomes
- Change from baseline in 6-item Hamiltons Depression Scale(Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups)
- Change from baseline in Perceived Stress Scale(Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups)
- Change from baseline in immunological markers in serum(Week 6)
- Change from baseline in Sheehan Disability Scale(Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups)
- Change from baseline in individual self-selected tasks(Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups)
- Change from baseline in depression (Symptom Check List-92)(Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups)
- Change from baseline in anxiety (Symptom Check List-92)(Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups)
- Change from baseline in Symptom Severity Scale (Quick Environmental Exposure and Sensitivity Inventory)(Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups)
- Change from baseline in noise sensitivity(Week 6, and 2½ and 4½ month follow-ups)
- Change from baseline in World Health Organization Quality Of Life Brief version(Week 6 and 4½ month follow-ups)
- Change from baseline in Chemical Intolerance Scale (Quick Environmental Exposure and Sensitivity Inventory)(Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups)
- Change from baseline in somatization (Symptom Check List-92)(Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups)
- Change from baseline in capsaicin-induced secondary punctate hyperalgesia(Week 6)