Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03503760
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2018-03-20
Brief Title:
Efficacy of Extremely Low Magnetic Field ELF in Fibromyalgic Patients
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
Azienda Ospedaliera Universitaria Integrata Verona
Study Overview
Official Title:
Efficacy of Extremely Low Magnetic Field ELF in Fibromyalgic Patients Effect on Symptoms Severity Sleep and Quality of Life
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None