Transcranial Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity: a Study Protocol for a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change from baseline in Life Impact Scale (Quick Environmental Exposure and Sensitivity Inventory)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •participation in another research study
研究组 & 干预措施
Pulsed electromagnetic fields
Pulsed electromagnetic fields is applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks
干预措施: Pulsed electromagnetic fields (Device)
Wearing the inactive device
The inactive device is worn on the head for 30 minutes twice a day for 7 days a week over 6 consecutive weeks
干预措施: w/o pulsed electromagnetic fields (Device)
结局指标
主要结局
Change from baseline in Life Impact Scale (Quick Environmental Exposure and Sensitivity Inventory)
时间窗: 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.
次要结局
- 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)