BEMER in the Treatment of Pain in Fibromyalgia. (Fibromyalgia)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
BEMER electromagnetic field therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Electromagnetic field therapy, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- diagnosis of fibromyalgia
- chronic persistent moderate or severe pain for more than 12 months
- average minimum pain intensity of 5 in the scale of 0 to 10 during the last 7 days
- age between 18 and 60 years
- female gender
Exclusion Criteria:
- an inflammatory rheumatic disease
- some other chronic pain disease as fibromyalgia
- psychiatric illness
- addiction to opiates
- substance abuse
- smoking
- a person with disability
- pregnancy and breast-feeding
Sites / Locations
- Jyväskylä Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
activated BEMER-device
inactivated BEMER-device
Arm Description
Activated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein).
Inactivated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein).
Outcomes
Primary Outcome Measures
Pain and stiffness
Visual Analogue Scale (VAS)
Secondary Outcome Measures
Cost-effectiveness
Questions about the use of drugs, visit to doctors, physiotherapy visits, and other health-care visits.
Severity of depression
Depression Scale (DEPS)
Quality of life
RAND-36 Questionnaire
Symptoms and functional ability
Fibromyalgia Impact Questionnaire (FIQ)
Full Information
NCT ID
NCT02310386
First Posted
November 21, 2014
Last Updated
June 12, 2018
Sponsor
Central Finland Hospital District
1. Study Identification
Unique Protocol Identification Number
NCT02310386
Brief Title
BEMER in the Treatment of Pain in Fibromyalgia.
Acronym
Fibromyalgia
Official Title
The Efficacy of the BEMER Electromagnetic Field Therapy in the Treatment of Fibromyalgia.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Finland Hospital District
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fibromyalgia is one the most common causes of chronic pain syndromes in women. It causes considerable costs in primary health care setting as well as specialized medical care sector.Electrotherapy and exercise therapy has shown to have short-term pain relieving effects in randomized controlled trials (RCT) among fibromyalgia patients. However, there is sparse knowledge about the effects of long-term RCTs in the treatment of pain in fibromyalgia, as there are no publications about cost-effectiveness analysis of such treatments.
The aim of this study is to investigate whether the BEMER electromagnetic field therapy device has beneficial long-term effects in the treatment of pain, and whether it improves fibromyalgia patients' quality of life. In addition, this study investigates whether the BEMER device treatment is cost-effective in the treatment of fibromyalgia patients.
Detailed Description
The participants of this study are working age female patients from the Central Finland Health Care District, and who have been treating because of severe pain. After eligibility has been assessed by health-related questionnaire and clinical examination, the participants will be randomly assigned into the treatment or control group. Treatment group patients will receive the loan activated BEMER-care unit, while controls will receive inactivated sham BEMER-unit. All participants will use the device regularly on a daily bases over three months. After one month treatment break, the treatment group will become a control group and control group will become a treatment group according cross-over design principle. Switching the groups will take place by changing the BEMER devices during the break. Throughout the study, both participants and researchers are unaware whether the participants are using activated or inactivated BEMER-devices. The research will be carried out and coordinated by Central Finland Central Hospital, and the research project will take place between September 2014 and June 2018.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Electromagnetic field therapy, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
activated BEMER-device
Arm Type
Active Comparator
Arm Description
Activated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein).
Arm Title
inactivated BEMER-device
Arm Type
Sham Comparator
Arm Description
Inactivated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein).
Intervention Type
Device
Intervention Name(s)
BEMER electromagnetic field therapy
Other Intervention Name(s)
BEMER, Innomed International AG, Lichtenstein
Intervention Description
To study the effects of three months electromagnetic field therapy on pain in women with fibromyalgia.
Primary Outcome Measure Information:
Title
Pain and stiffness
Description
Visual Analogue Scale (VAS)
Time Frame
Change from Baseline Pain and Stiffness at 3 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Description
Questions about the use of drugs, visit to doctors, physiotherapy visits, and other health-care visits.
Time Frame
Three Months Before and After the Start of the Intervention
Title
Severity of depression
Description
Depression Scale (DEPS)
Time Frame
Change from Baseline Severity of Depression at 3 Months
Title
Quality of life
Description
RAND-36 Questionnaire
Time Frame
Change from Baseline Quality of Life at 3 month
Title
Symptoms and functional ability
Description
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
Change from Baseline Symptoms and Functional Ability at 3 months
Other Pre-specified Outcome Measures:
Title
Average weekly amount of symptoms (pain, stiffness, quality of sleep, vitality)
Description
VAS
Time Frame
Up to 3 months
Title
Number of daily treatments/drugs
Description
Diary
Time Frame
Up to 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of fibromyalgia
chronic persistent moderate or severe pain for more than 12 months
average minimum pain intensity of 5 in the scale of 0 to 10 during the last 7 days
age between 18 and 60 years
female gender
Exclusion Criteria:
an inflammatory rheumatic disease
some other chronic pain disease as fibromyalgia
psychiatric illness
addiction to opiates
substance abuse
smoking
a person with disability
pregnancy and breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jari Ylinen, PhD
Organizational Affiliation
Central Finland Health Care District, Jyväskylä, Finland, FIN-40620
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jyväskylä Central Hospital
City
Jyväskylä
State/Province
Central Finland
ZIP/Postal Code
40620
Country
Finland
12. IPD Sharing Statement
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BEMER in the Treatment of Pain in Fibromyalgia.
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