BEMER in the Treatment of Pain in Fibromyalgia. (Fibromyalgia)

June 12, 2018 updated by: Central Finland Hospital District

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Central Finland
      • Jyväskylä, Central Finland, Finland, 40620
        • Jyväskylä Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three Months Before and After the Start of the Intervention
Severity of depression
Time Frame: Change from Baseline Severity of Depression at 3 Months
Depression Scale (DEPS)
Change from Baseline Severity of Depression at 3 Months
Quality of life
Time Frame: Change from Baseline Quality of Life at 3 month
RAND-36 Questionnaire
Change from Baseline Quality of Life at 3 month
Symptoms and functional ability
Time Frame: Change from Baseline Symptoms and Functional Ability at 3 months
Fibromyalgia Impact Questionnaire (FIQ)
Change from Baseline Symptoms and Functional Ability at 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average weekly amount of symptoms (pain, stiffness, quality of sleep, vitality)
Time Frame: Up to 3 months
VAS
Up to 3 months
Number of daily treatments/drugs
Time Frame: Up to 3 months
Diary
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Finland Hospital District

Investigators

  • Principal Investigator: Jari Ylinen, PhD, Central Finland Health Care District, Jyväskylä, Finland, FIN-40620

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnro 1/2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on BEMER electromagnetic field therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe