Clinical trial NCT02310386: BEMER in the Treatment of Pain in Fibromyalgia.
Official title: The Efficacy of the BEMER Electromagnetic Field Therapy in the Treatment of Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Electromagnetic field therapy
Randomized controlled trial
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain and stiffness
timeFrame: Change from Baseline Pain and Stiffness at 3 months
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: Three Months Before and After the Start of the Intervention
measure: Severity of depression
timeFrame: Change from Baseline Severity of Depression at 3 Months
measure: Quality of life
timeFrame: Change from Baseline Quality of Life at 3 month
measure: Symptoms and functional ability
timeFrame: Change from Baseline Symptoms and Functional Ability at 3 months
Other outcomes:
measure: Average weekly amount of symptoms (pain, stiffness, quality of sleep, vitality)
timeFrame: Up to 3 months
measure: Number of daily treatments/drugs
timeFrame: Up to 3 months
Locations:
city: Jyväskylä
country: Finland
facility: Jyväskylä Central Hospital
state: Central Finland
Study officials:
affiliation: Central Finland Health Care District, Jyväskylä, Finland, FIN-40620
name: Jari Ylinen, PhD
role: PRINCIPAL_INVESTIGATOR
References: