FibromyalgiaNCT02231541
Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia
A study testing Very Low Frequency Magnetic Fields in people with Fibromyalgia, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Very Low Frequency Magnetic Fields
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 2010)
- Subjects aged between 18 and 60 years
Who cannot join
- Pregnant patients
- Patients with pacemaker or other metal implants
- Systemic infectious disorders
- Neoplastic disorders
- Epilepsy
- Severe heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia
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.
- Conditions
- Fibromyalgia
- Being tested
- Very Low Frequency Magnetic Fields
- Keywords
- Fibromylgia, Magnetic Fields, Pain, Visual Analogue scale
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Frequency Magnetic FieldsDevice
Also called ELF
The device is set to an analgesic program lasting about 30 minutes.
Very Low Frequency Magnetic FieldsDevice
Also called ELF
The device is turned off.
| Study group | Role | What they receive |
|---|---|---|
| Very low frequency magnetic fields | Experimental | 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. Receives: Device: Very Low Frequency Magnetic Fields |
| Turned off very low frequency magnetic fields | Placebo comparator | 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. Receives: Device: Very Low Frequency Magnetic Fields |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 4 weeks, 12 weeks
Secondary outcomes (3)
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).
Measured: baseline, 4 weeks, 12 weeks
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.
Measured: baseline, 4 weeks, 12 weeks
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).
Measured: baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, University of Roma La Sapienza
- Investigators
- Vincenzo Maria Saraceni, Principal investigator, Umberto I Hospital, Sapienza University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231541
- Sponsor's protocol ID
- 3295/2014
- Status last verified
- Sep 2014
- First submitted
- 8 Aug 2014
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28475205
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT02231541
- Acronym / sponsor ID
- 3295/2014
- Conditions
- Fibromyalgia
- Keywords
- Fibromylgia, Magnetic Fields, Pain, Visual Analogue scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low frequency magnetic fields | Experimental | Device: Very Low Frequency Magnetic FieldsThe 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. |
| Turned off very low frequency magnetic fields | Placebo comparator | Device: Very Low Frequency Magnetic FieldsThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 2010)
- Subjects aged between 18 and 60 years
Key exclusion criteria (6 listed)
- Pregnant patients
- Patients with pacemaker or other metal implants
- Systemic infectious disorders
- Neoplastic disorders
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very Low Frequency Magnetic FieldsAlso: ELFThe device is set to an analgesic program lasting about 30 minutes. | Device | Very low frequency magnetic fields |
| Very Low Frequency Magnetic FieldsAlso: ELFThe device is turned off. | Device | Turned off very low frequency magnetic fields |
Primary outcome
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 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.
3 secondary outcomes
Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Derived from this study: PubMed 28475205Paolucci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Maria Saraceni principal investigator
Umberto I Hospital, Sapienza University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Frequency Magnetic Fields in people with Fibromyalgia, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks (time frame: baseline, 4 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02231541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.