Fibromyalgia Clinical Trial
— FibromyalgiaOfficial title:
The Efficacy of the BEMER Electromagnetic Field Therapy in the Treatment of Fibromyalgia.
Verified date | December 2014 |
Source | Central Finland Hospital District |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Jyväskylä Central Hospital | Jyväskylä | Central Finland |
Lead Sponsor | Collaborator |
---|---|
Central Finland Hospital District |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Average weekly amount of symptoms (pain, stiffness, quality of sleep, vitality) | VAS | Up to 3 months | |
Other | Number of daily treatments/drugs | Diary | Up to 3 months | |
Primary | Pain and stiffness | Visual Analogue Scale (VAS) | Change from Baseline Pain and Stiffness at 3 months | |
Secondary | 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 | |
Secondary | Severity of depression | Depression Scale (DEPS) | Change from Baseline Severity of Depression at 3 Months | |
Secondary | Quality of life | RAND-36 Questionnaire | Change from Baseline Quality of Life at 3 month | |
Secondary | Symptoms and functional ability | Fibromyalgia Impact Questionnaire (FIQ) | Change from Baseline Symptoms and Functional Ability at 3 months |
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