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Trial record 50 of 277 for:    quality | "Fibromyalgia"

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

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ClinicalTrials.gov Identifier: NCT02310386
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Central Finland Hospital District

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Device: BEMER electromagnetic field therapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of the BEMER Electromagnetic Field Therapy in the Treatment of Fibromyalgia.
Study Start Date : September 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: BEMER, Innomed International AG, Lichtenstein




Primary Outcome Measures :
  1. Pain and stiffness [ Time Frame: Change from Baseline Pain and Stiffness at 3 months ]
    Visual Analogue Scale (VAS)


Secondary Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310386


Locations
Finland
Jyväskylä Central Hospital
Jyväskylä, Central Finland, Finland, 40620
Sponsors and Collaborators
Central Finland Hospital District
Investigators
Principal Investigator: Jari Ylinen, PhD Central Finland Health Care District, Jyväskylä, Finland, FIN-40620

Responsible Party: Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT02310386     History of Changes
Other Study ID Numbers: Dnro 1/2014
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: December 2014

Keywords provided by Central Finland Hospital District:
Fibromyalgia
Electromagnetic field therapy
Randomized controlled trial

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases