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Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

Primary Purpose

Multiple Chemical Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pulsed electromagnetic fields
w/o pulsed electromagnetic fields
Sponsored by
The Danish Research Centre for Chemical Sensitivities
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Chemical Sensitivity focused on measuring multiple chemical sensitivity, re5 therapy, pulsed electromagnetic fields

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Danish Research Centre for Chemical Sensitivities

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pulsed electromagnetic fields

Wearing the inactive device

Arm Description

Pulsed electromagnetic fields is applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks

The inactive device is worn on the head for 30 minutes twice a day for 7 days a week over 6 consecutive weeks

Outcomes

Primary Outcome Measures

Change from baseline in Life Impact Scale (Quick Environmental Exposure and Sensitivity Inventory)
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 Outcome Measures

Change from baseline in Symptom Severity Scale (Quick Environmental Exposure and Sensitivity Inventory)
The Symptom severity scale from the QEESI consist of ten items where responses are rated on an eleven point scale ranging from "not at all a problem" (0) to "disabling symptoms" (10), resulting in a score range from 0 to 100.
Change from baseline in Chemical Intolerance Scale (Quick Environmental Exposure and Sensitivity Inventory)
The Chemical Intolerance scale from the QEESI consist of ten items where responses are rated on an eleven point scale ranging from "not at all a problem" (0) to "disabling symptoms" (10), resulting in a score range from 0 to 100.
Change from baseline in Sheehan Disability Scale
The Sheehan Disability Scale (SDS) is widely used in psychiatry, but has also been applied to many other chronic medical illnesses. It uses visuo-spatial, numeric and descriptive anchors to measure impaired functioning in three domains: work, social life and family life. The scale generates four disability scores, one for each domain and a total score by adding up the three individual domain scores
Change from baseline in individual self-selected tasks
In addition to the Life Impact scale used as the primary outcome measure, the participants will need to select three tasks in the areas of work, social life and family life, which are impaired by MCS at baseline. The degree of impairment associated with each task is scored on a scale from 0-10 with visuo-spatial, numeric and descriptive anchors similar to SDS.
Change from baseline in noise sensitivity
To measure the participants' sensitivity to noise, they will be asked to grade their responses to 10 different noises (e.g. drone of a machine, stroke of a hammer, rustling of paper) on a 5-point Likert scale.
Change from baseline in depression (Symptom Check List-92)
The Symptom Checklist 92 (SCL-92) subscales for depression, anxiety and somatization will be included. These subscales comprise 35 items on which responses are rated on a 5-point Likert scale ranging from not at all to very much.
Change from baseline in anxiety (Symptom Check List-92)
Change from baseline in somatization (Symptom Check List-92)
Change from baseline in 6-item Hamiltons Depression Scale
The 6-item Hamilton Depression Rating Scale (HAM-D6) is a short self-administered measure of depression. The scale has been shown to be as sensitive as the more widely used 17-item Hamilton Depression Rating Scale (HAM-D17) to measure antidepressive treatment effects.
Change from baseline in Perceived Stress Scale
The short version of the Perceived Stress Scale (PSS-10) consists of 10 questions and measures the self-perception of stress by grading how different life situations are perceived. The PSS-10 has been shown to be a valid and reliable measure of perceived stress.
Change from baseline in World Health Organization Quality Of Life Brief version
The brief version of World Health Organization Quality Of Life (WHOQOL-BREF) is a short multidimensional questionnaire, which measures health-related quality of life. The scale consists of four domains: physical health, psychological well-being, social relationships and environment.
Change from baseline in capsaicin-induced secondary punctate hyperalgesia
Change from baseline in immunological markers in serum
IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17, IL-21, IL-22, IL-23, TNFα, IFNγ

Full Information

First Posted
April 12, 2013
Last Updated
April 15, 2014
Sponsor
The Danish Research Centre for Chemical Sensitivities
Collaborators
Aage Bangs Fond
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1. Study Identification

Unique Protocol Identification Number
NCT01834781
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Danish Research Centre for Chemical Sensitivities
Collaborators
Aage Bangs Fond

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chemical Sensitivity
Keywords
multiple chemical sensitivity, re5 therapy, pulsed electromagnetic fields

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsed electromagnetic fields
Arm Type
Active Comparator
Arm Description
Pulsed electromagnetic fields is applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks
Arm Title
Wearing the inactive device
Arm Type
Placebo Comparator
Arm Description
The inactive device is worn on the head for 30 minutes twice a day for 7 days a week over 6 consecutive weeks
Intervention Type
Device
Intervention Name(s)
Pulsed electromagnetic fields
Other Intervention Name(s)
Re5 Independent System, Re5 therapy
Intervention Type
Device
Intervention Name(s)
w/o pulsed electromagnetic fields
Primary Outcome Measure Information:
Title
Change from baseline in Life Impact Scale (Quick Environmental Exposure and Sensitivity Inventory)
Description
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.
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Secondary Outcome Measure Information:
Title
Change from baseline in Symptom Severity Scale (Quick Environmental Exposure and Sensitivity Inventory)
Description
The Symptom severity scale from the QEESI consist of ten items where responses are rated on an eleven point scale ranging from "not at all a problem" (0) to "disabling symptoms" (10), resulting in a score range from 0 to 100.
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in Chemical Intolerance Scale (Quick Environmental Exposure and Sensitivity Inventory)
Description
The Chemical Intolerance scale from the QEESI consist of ten items where responses are rated on an eleven point scale ranging from "not at all a problem" (0) to "disabling symptoms" (10), resulting in a score range from 0 to 100.
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in Sheehan Disability Scale
Description
The Sheehan Disability Scale (SDS) is widely used in psychiatry, but has also been applied to many other chronic medical illnesses. It uses visuo-spatial, numeric and descriptive anchors to measure impaired functioning in three domains: work, social life and family life. The scale generates four disability scores, one for each domain and a total score by adding up the three individual domain scores
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in individual self-selected tasks
Description
In addition to the Life Impact scale used as the primary outcome measure, the participants will need to select three tasks in the areas of work, social life and family life, which are impaired by MCS at baseline. The degree of impairment associated with each task is scored on a scale from 0-10 with visuo-spatial, numeric and descriptive anchors similar to SDS.
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in noise sensitivity
Description
To measure the participants' sensitivity to noise, they will be asked to grade their responses to 10 different noises (e.g. drone of a machine, stroke of a hammer, rustling of paper) on a 5-point Likert scale.
Time Frame
Week 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in depression (Symptom Check List-92)
Description
The Symptom Checklist 92 (SCL-92) subscales for depression, anxiety and somatization will be included. These subscales comprise 35 items on which responses are rated on a 5-point Likert scale ranging from not at all to very much.
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in anxiety (Symptom Check List-92)
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in somatization (Symptom Check List-92)
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in 6-item Hamiltons Depression Scale
Description
The 6-item Hamilton Depression Rating Scale (HAM-D6) is a short self-administered measure of depression. The scale has been shown to be as sensitive as the more widely used 17-item Hamilton Depression Rating Scale (HAM-D17) to measure antidepressive treatment effects.
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in Perceived Stress Scale
Description
The short version of the Perceived Stress Scale (PSS-10) consists of 10 questions and measures the self-perception of stress by grading how different life situations are perceived. The PSS-10 has been shown to be a valid and reliable measure of perceived stress.
Time Frame
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Title
Change from baseline in World Health Organization Quality Of Life Brief version
Description
The brief version of World Health Organization Quality Of Life (WHOQOL-BREF) is a short multidimensional questionnaire, which measures health-related quality of life. The scale consists of four domains: physical health, psychological well-being, social relationships and environment.
Time Frame
Week 6 and 4½ month follow-ups
Title
Change from baseline in capsaicin-induced secondary punctate hyperalgesia
Time Frame
Week 6
Title
Change from baseline in immunological markers in serum
Description
IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17, IL-21, IL-22, IL-23, TNFα, IFNγ
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Danish Research Centre for Chemical Sensitivities
City
Gentofte
ZIP/Postal Code
DK-2820
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23947742
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.
Results Reference
derived

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Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

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