Does a three week treatment with microcurrents improve the functional level of people with fibromyalgia syndrome?
| ISRCTN | ISRCTN04459421 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04459421 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/03/2010
- Registration date
- 09/09/2010
- Last edited
- 09/09/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Isabel Salvat
Scientific
Scientific
Facultat de Medicina i Ciències de la Salut
C/Sant Llorenç 21
Reus (Tarragona)
43201
Spain
Study information
| Study design | Single centre single blind randomised placebo controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Does a three week treatment with microcurrents improve the functional level of people with fibromyalgia syndrome? A randomised placebo-controlled trial |
| Study objectives | 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(s) | Clinical Research Ethical Committee of the Hospital Sant Joan (Reus) on the 27th of April 2006 (Ref. No, 06-04-27/ 4proju) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2006 |
| Completion date | 01/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 44 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/05/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Facultat de Medicina i Ciències de la Salut
Reus (Tarragona)
43201
Spain
43201
Spain
Sponsor information
University Rovira i Virgili (Spain)
University/education
University/education
C/Sant Llorenç 21
Reus (Tarragona)
43201
Spain
"ROR" |
https://ror.org/00g5sqv46 |
|---|
Funders
Funder type
University/education
University Rovira i Virgili (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
