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Completed

NCT Number: NCT02310386

BEMER in the Treatment of Pain in Fibromyalgia.

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jyväskylä Central Hospital

Jyväskylä, Central Finland, 40620, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BEMER electromagnetic field therapy

Device

To study the effects of three months electromagnetic field therapy on pain in women with fibromyalgia.

Other names: BEMER, Innomed International AG, Lichtenstein

Primary outcomes

  1. Pain and stiffness

    Time frame: Change from Baseline Pain and Stiffness at 3 months

    Visual Analogue Scale (VAS)

Secondary outcomes

  1. Cost-effectiveness

    Time frame: Three Months Before and After the Start of the Intervention

    Questions about the use of drugs, visit to doctors, physiotherapy visits, and other health-care visits.

  2. Severity of depression

    Time frame: Change from Baseline Severity of Depression at 3 Months

    Depression Scale (DEPS)

  3. Quality of life

    Time frame: Change from Baseline Quality of Life at 3 month

    RAND-36 Questionnaire

  4. Symptoms and functional ability

    Time frame: Change from Baseline Symptoms and Functional Ability at 3 months

    Fibromyalgia Impact Questionnaire (FIQ)

Other outcomes

  1. Average weekly amount of symptoms (pain, stiffness, quality of sleep, vitality)

    Time frame: Up to 3 months

    VAS

  2. Number of daily treatments/drugs

    Time frame: Up to 3 months

    Diary

Sponsors and collaborators

Lead sponsor

Central Finland Hospital District

Other

Registry information

Official study title

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

Acronym: Fibromyalgia

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 8, 2014
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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