BEMER in the Treatment of Pain in Fibromyalgia.

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of the BEMER Electromagnetic Field Therapy in the Treatment of Fibromyalgia.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: BEMER electromagnetic field therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: activated BEMER-device<br>Activated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein). | Device: BEMER electromagnetic field therapy<br>* To study the effects of three months electromagnetic field therapy on pain in women with fibromyalgia.<br>* Other names: BEMER, Innomed International AG, Lichtenstein;|
| Sham Comparator: inactivated BEMER-device<br>Inactivated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein). | Device: BEMER electromagnetic field therapy<br>* To study the effects of three months electromagnetic field therapy on pain in women with fibromyalgia.<br>* Other names: BEMER, Innomed International AG, Lichtenstein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and stiffness | Visual Analogue Scale (VAS) | Change from Baseline Pain and Stiffness at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness | Questions about the use of drugs, visit to doctors, physiotherapy visits, and other health-care visits. | Three Months Before and After the Start of the Intervention | 
| Severity of depression | Depression Scale (DEPS) | Change from Baseline Severity of Depression at 3 Months | 
| Quality of life | RAND-36 Questionnaire | Change from Baseline Quality of Life at 3 month | 
| Symptoms and functional ability | Fibromyalgia Impact Questionnaire (FIQ) | Change from Baseline Symptoms and Functional Ability at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Electromagnetic field therapy, Randomized controlled trial