FibromyalgiaFibromyalgiaNCT02310386
BEMER in the Treatment of Pain in Fibromyalgia.
A study testing BEMER electromagnetic field therapy in people with Fibromyalgia, run by Central Finland Hospital District at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- BEMER electromagnetic field therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- BEMER electromagnetic field therapy
- Keywords
- Fibromyalgia, Electromagnetic field therapy, Randomized controlled trial
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEMER electromagnetic field therapyDevice
Also called BEMER, Innomed International AG, Lichtenstein
To study the effects of three months electromagnetic field therapy on pain in women with fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| activated BEMER-device | Active comparator | Activated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein). Receives: Device: BEMER electromagnetic field therapy |
| inactivated BEMER-device | Sham comparator | Inactivated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein). Receives: Device: BEMER electromagnetic field therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and stiffness
Visual Analogue Scale (VAS)
Measured: Change from Baseline Pain and Stiffness at 3 months
Secondary outcomes (4)
Cost-effectiveness
Questions about the use of drugs, visit to doctors, physiotherapy visits, and other health-care visits.
Measured: Three Months Before and After the Start of the Intervention
Severity of depression
Depression Scale (DEPS)
Measured: Change from Baseline Severity of Depression at 3 Months
Quality of life
RAND-36 Questionnaire
Measured: Change from Baseline Quality of Life at 3 month
Symptoms and functional ability
Fibromyalgia Impact Questionnaire (FIQ)
Measured: Change from Baseline Symptoms and Functional Ability at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jari Ylinen, PhD, Principal investigator, Central Finland Health Care District, Jyväskylä, Finland, FIN-40620
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310386
- Sponsor's protocol ID
- Dnro 1/2014
- Acronym
- Fibromyalgia
- Status last verified
- Dec 2014
- First submitted
- 21 Nov 2014
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the BEMER Electromagnetic Field Therapy in the Treatment of Fibromyalgia.
- ClinicalTrials.gov ID
- NCT02310386
- Acronym / sponsor ID
- Fibromyalgia / Dnro 1/2014
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Electromagnetic field therapy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| activated BEMER-device | Active comparator | Device: BEMER electromagnetic field therapyActivated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein). |
| inactivated BEMER-device | Sham comparator | Device: BEMER electromagnetic field therapyInactivated BEMER electromagnetic field therapy (BEMER, Innomed International, AG, Lichtenstein). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- an inflammatory rheumatic disease
- some other chronic pain disease as fibromyalgia
- psychiatric illness
- addiction to opiates
- substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEMER electromagnetic field therapyAlso: BEMER, Innomed International AG, LichtensteinTo study the effects of three months electromagnetic field therapy on pain in women with fibromyalgia. | Device | activated BEMER-device, inactivated BEMER-device |
Primary outcome
Pain and stiffness
Time frame: Change from Baseline Pain and Stiffness at 3 months
Visual Analogue Scale (VAS)
4 secondary outcomes
Cost-effectiveness
Time frame: Three Months Before and After the Start of the Intervention
Severity of depression
Time frame: Change from Baseline Severity of Depression at 3 Months
Quality of life
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari Ylinen, PhD principal investigator
Central Finland Health Care District, Jyväskylä, Finland, FIN-40620
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEMER electromagnetic field therapy in people with Fibromyalgia, run by Central Finland Hospital District at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and stiffness (time frame: Change from Baseline Pain and Stiffness at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.