NCT02310386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 13, 2018

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

November 21, 2014

Last Update Submit

June 12, 2018

Conditions

Fibromyalgia

Keywords

FibromyalgiaElectromagnetic field therapyRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Pain and stiffness

    Visual Analogue Scale (VAS)

    Change from Baseline Pain and Stiffness at 3 months

Secondary Outcomes (4)

  • Cost-effectiveness

    Three Months Before and After the Start of the Intervention

  • Severity of depression

    Change from Baseline Severity of Depression at 3 Months

  • Quality of life

    Change from Baseline Quality of Life at 3 month

  • Symptoms and functional ability

    Change from Baseline Symptoms and Functional Ability at 3 months

Other Outcomes (2)

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

    Up to 3 months

  • Number of daily treatments/drugs

    Up to 3 months

Study Arms (2)

activated BEMER-device

ACTIVE COMPARATOR

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

Device: BEMER electromagnetic field therapy

inactivated BEMER-device

SHAM COMPARATOR

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

Device: BEMER electromagnetic field therapy

Interventions

BEMER electromagnetic field therapyDEVICE

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

Also known as: BEMER, Innomed International AG, Lichtenstein
activated BEMER-deviceinactivated BEMER-device

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jyväskylä Central Hospital

Jyväskylä, Central Finland, 40620, Finland

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Jari Ylinen, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2014

First Posted

December 8, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 13, 2018

Record last verified: 2014-12

Locations

FI(1)