Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Does a three week treatment with microcurrents improve the functional level of people with fibromyalgia syndrome? A randomised placebo-controlled trial
Acronym
Study hypothesis
Fibromyalgia syndrome is a common medical condition characterised by chronic widespread pain and allodynia. Existing data suggest that disturbed central pain processing plays an important role in its pathogenesis.
Microcurrent treatment reduces Fibromyalgia Syndrome (FMS) symptoms and thus improves the functional ability of those affected.
Ethics approval
Clinical Research Ethical Committee of the Hospital Sant Joan (Reus) on the 27th of April 2006 (Ref. No, 06-04-27/ 4proju)
Study design
Single centre single blind randomised placebo controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Fibromyalgia syndrome (FMS)
Intervention
The subjects will be randomised into a microcurrent group and a placebo group. They all will receive two 30 minute sessions a week for three weeks. They will ask to attend all sessions but can leave the study at any time.
Treatment involves applying self-adhesive electrodes to the two areas that the subject find most painful at that moment (Intensity = 100 microamperes; frequency between 30 and 40 Hz; two channels). The researcher chooses the electrode position on the basis of these indicators and using the research teams predefined protocol, which have standardized the electrode positions. The subject will be then placed in a prone, lateral, or supine position as comfortable as possible with supporting cushions.
The placebo group will believe that the equipment would be switched on and off so that they will think they will receive the same treatment. However, the equipment will remain off at all times and the current will be not applied. This simulation is possible because microcurrents are not sufficiently intense to stimulate the sensitive nerve fibers and thus are not perceived by patients.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Fibromyalgia Impact Questionnaire (Cuestionario de Impacto de la Fibromialgia [CIF])
The values of the CIF are between 0 and 100, 0 being the best state of health and 100 the worst. CIF will be assessed at the start of treatment (CIF0), at the end of the treatment (CIF1) and at one month after treatment (CIF2).
Secondary outcome measures
Visual analog scale (VAS) (0 = no pain, 10 = unbearable pain), assessed at the start of treatment (VAS0), at end of the treatment (VAS1) and at one month after treatment (VAS2).
Overall trial start date
01/03/2006
Overall trial end date
01/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients of either sex diagnosed with FMS in accordance with the American College of Rheumatologys criteria (final age range at end of recruitment was 33-71 years)
2. Recruited from the Catalan Association for People Affected by FMS
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
44 patients
Participant exclusion criteria
1. Suffering from a multiple organic disease
2. Pregnant
3. Patients with a demand-type cardiac pacemaker
4. Receiving physiotherapy treatment or having finished treatment in the previous month
Recruitment start date
01/03/2006
Recruitment end date
01/05/2010
Locations
Countries of recruitment
Spain
Trial participating centre
Facultat de Medicina i Ciències de la Salut
Reus (Tarragona)
43201
Spain
Funders
Funder type
University/education
Funder name
University Rovira i Virgili (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary