BEMER in the Treatment of Pain in Fibromyalgia.

NCT ID: NCT02310386

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

activated BEMER-device

Activated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein).

Group Type: ACTIVE_COMPARATOR

BEMER electromagnetic field therapy

Intervention Type: DEVICE

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

inactivated BEMER-device

Inactivated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein).

Group Type: SHAM_COMPARATOR

BEMER electromagnetic field therapy

Intervention Type: DEVICE

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

Interventions

BEMER electromagnetic field therapy

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

Intervention Type: DEVICE

Other Intervention Names

BEMER, Innomed International AG, Lichtenstein

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Central Finland Hospital District

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jari Ylinen, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Finland Health Care District, Jyväskylä, Finland, FIN-40620

Locations

Jyväskylä Central Hospital

Jyväskylä, Central Finland, Finland

Countries

Finland

Other Identifiers

Dnro 1/2014

Identifier Type: -

Identifier Source: org_study_id