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Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Very Low Frequency Magnetic Fields
Very Low Frequency Magnetic Fields
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromylgia, Magnetic Fields, Pain, Visual Analogue scale

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 2010)
  • Subjects aged between 18 and 60 years

Exclusion Criteria:

  • Pregnant patients
  • Patients with pacemaker or other metal implants
  • Systemic infectious disorders
  • Neoplastic disorders
  • Epilepsy
  • Severe heart disease

Sites / Locations

  • Umberto I Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Very low frequency magnetic fields

Turned off very low frequency magnetic fields

Arm Description

The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues.

The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues.

Outcomes

Primary Outcome Measures

Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.

Secondary Outcome Measures

Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks
The questionnaire assesses disability and symptoms. It is divided into ten sub-categories that assess the range of symptoms presented by the patient and the response to therapy and structured in twenty questions that assess disability in activities of daily living (ADL), the difficulties in practice, the feeling of general well-being, sleep, severity of symptoms, including pain, fatigue, depression, anxiety and rigidity. The questionnaire is self-administered disease-specific, and each item is based on a metric scale ranging from 0 (no disability) to 10 (maximum disability).
Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks
The questionnaire assesses the response to therapy and the progression of the disease. Specifically it evaluates fatigue, sleep disorders and pain. The questionnaire is disease-specific, self-administered and is constituted by a "pain map", called Self-Assessment Pain Scale (SAPS) characterized by a metric scale from 0 to 3 and by two numerical scales for the assessment of fatigue and sleep quality, each characterized by a metric scale between 0 and 106.
Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
This questionnaire assesses disability. It is divided into eight domains that assess the dressing, eating, getting up, walking, hygiene, activities of achievement and activities of daily life. The questionnaire is self-administered and each item is based on a metric scale ranging from 0 (no disability) to 3 (maximum disability).

Full Information

First Posted
August 8, 2014
Last Updated
June 4, 2015
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT02231541
Brief Title
Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia
Official Title
Effectiveness of Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine the effectiveness of treatment with very low frequency electromagnetic fields on the reduction of pain in patients with fibromylgia, disease presenting with widespread musculoskeletal pain usually associated with other symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromylgia, Magnetic Fields, Pain, Visual Analogue scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Very low frequency magnetic fields
Arm Type
Experimental
Arm Description
The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues.
Arm Title
Turned off very low frequency magnetic fields
Arm Type
Placebo Comparator
Arm Description
The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues.
Intervention Type
Device
Intervention Name(s)
Very Low Frequency Magnetic Fields
Other Intervention Name(s)
ELF
Intervention Description
The device is set to an analgesic program lasting about 30 minutes.
Intervention Type
Device
Intervention Name(s)
Very Low Frequency Magnetic Fields
Other Intervention Name(s)
ELF
Intervention Description
The device is turned off.
Primary Outcome Measure Information:
Title
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Description
It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.
Time Frame
baseline, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks
Description
The questionnaire assesses disability and symptoms. It is divided into ten sub-categories that assess the range of symptoms presented by the patient and the response to therapy and structured in twenty questions that assess disability in activities of daily living (ADL), the difficulties in practice, the feeling of general well-being, sleep, severity of symptoms, including pain, fatigue, depression, anxiety and rigidity. The questionnaire is self-administered disease-specific, and each item is based on a metric scale ranging from 0 (no disability) to 10 (maximum disability).
Time Frame
baseline, 4 weeks, 12 weeks
Title
Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks
Description
The questionnaire assesses the response to therapy and the progression of the disease. Specifically it evaluates fatigue, sleep disorders and pain. The questionnaire is disease-specific, self-administered and is constituted by a "pain map", called Self-Assessment Pain Scale (SAPS) characterized by a metric scale from 0 to 3 and by two numerical scales for the assessment of fatigue and sleep quality, each characterized by a metric scale between 0 and 106.
Time Frame
baseline, 4 weeks, 12 weeks
Title
Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
Description
This questionnaire assesses disability. It is divided into eight domains that assess the dressing, eating, getting up, walking, hygiene, activities of achievement and activities of daily life. The questionnaire is self-administered and each item is based on a metric scale ranging from 0 (no disability) to 3 (maximum disability).
Time Frame
baseline, 4 weeks, 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 2010) Subjects aged between 18 and 60 years Exclusion Criteria: Pregnant patients Patients with pacemaker or other metal implants Systemic infectious disorders Neoplastic disorders Epilepsy Severe heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Maria Saraceni
Organizational Affiliation
Umberto I Hospital, Sapienza University of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umberto I Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
28475205
Citation
Paolucci T, Piccinini G, Iosa M, Piermattei C, de Angelis S, Grasso MR, Zangrando F, Saraceni VM. Efficacy of extremely low-frequency magnetic field in fibromyalgia pain: A pilot study. J Rehabil Res Dev. 2016;53(6):1023-1034. doi: 10.1682/JRRD.2015.04.0061.
Results Reference
derived

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Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

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