Condition category
Nervous System Diseases
Date applied
19/03/2010
Date assigned
09/09/2010
Last edited
09/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Isabel Salvat

ORCID ID

Contact details

Facultat de Medicina i Ciències de la Salut
C/Sant Llorenç 21
Reus (Tarragona)
43201
Spain

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 team’s 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 Rheumatology’s 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

Sponsor information

Organisation

University Rovira i Virgili (Spain)

Sponsor details

C/Sant Llorenç 21
Reus (Tarragona)
43201
Spain

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes