Efficacy of Extremely Low Magnetic Field (ELF) in Fibromyalgic Patients: Effect on Symptoms Severity, Sleep and Quality of Life.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Enrollment
- 48
- Primary Endpoint
- FIQ
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a randomized double-blind crossover study. The investigators applied ELF with a device named "LIMFA Therapy®" to 48 fibromyalgic patients, assigned in two groups (true-sham and sham-true). Fibromyalgia severity was assessed with the Fibromyalgia Impact Questionnaire (FIQ), quality of sleep with the Pittsburgh Sleep Quality Index (PSQI) questionnaire and global quality of life with Short Form-12 of Physical and Mental Health Summary (SF-12) questionnaire.
Detailed Description
In the first part of the protocol the group true-sham received 6 twice a week sessions of true ELF therapy of 1 hour, following the antinflammatory, analgesic and biorhythm settings of the device "LIMFA Therapy®". The sham-true group patients received 6 twice a week sessions of sham therapy (no therapy). During the second part of the protocol, the true-sham group received the sham therapy twice a week for 3 weeks and the sham-true group received the actual true therapy twice a week for 3 weeks. For the assessment of pain, sleep quality and global quality of life, a set of questionnaires were administrated at specific stages of the protocol. Questionnaires were administrated every three weeks: before the first therapy, after the first course of therapy, after the washout period, after the second course of therapy, and 3 weeks after the end of treatment.
Investigators
Alvise Martini
MD, Principal Investigator
Azienda Ospedaliera Universitaria Integrata Verona
Eligibility Criteria
Inclusion Criteria
- •patients with an established fibromyalgia diagnosis of at least three months according to American College of Rheumatology 2010 modified criteria and no responsive to their current therapy.
- •patients were not responsive to amitryptiline, selective serotonin reuptake inhibitor (SSRI) or duloxetine and pregabalin (with a pain reduction below 50% compared to pre-therapy or intolerant to these drugs)
- •patients with a pain level measured with Visual Analogue Scale for Pain (VAS) \> 50/
- •patients that had been taking other drugs or food supplements for the treatment of fibromyalgia for at least 6 months.
Exclusion Criteria
- •patients that completed either physiotherapy or acupuncture or behavioral treatment in the last 6 months
- •patients that were affected by other painful syndromes or potentially painful syndromes other than fibromyalgia.
- •pregnant women
- •pace-maker carriers
- •oncologic patients
- •tuberculotic patients.
Outcomes
Primary Outcomes
FIQ
Time Frame: 12 weeks
Fibromyalgia Impact Questionnaire is a comprehensive questionnaire for evaluation of fibromyalgia severity. The scale range is from 0 to100 and higher values are considered worse outcomes. In the severity analysis a FIQ score from 0 to 38 represents a mild condition, from 39 to 58 represents a moderate condition, and from 59 to 100 a severe condition. A reduction of FIQ between 10 and 20% is related to a clinically significative intervention. (Bennett, R. et al.(2009))
Secondary Outcomes
- PSQI(12 weeks)
- SF-12(12 weeks)