FibromyalgiaNCT01180244

The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients

A study testing Noninvasive cortical electrical stimulation in people with Fibromyalgia, run by McLaren Regional Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether persons treated with a low-intensity, noninvasive form of cortical electrical stimulation experience a reduction in symptoms of fibromyalgia different than persons receiving a sham treatment. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Fibromyalgia
What is being tested?: Noninvasive cortical electrical stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 1 siteUnited States
Study dates: Jan 2002to Jul 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 through 65 years
An ability to read and comprehend English
Completion of a minimum of grade 8 education
Diagnosis of fibromyalgia in 1999 or earlier, by a rheumatologist or appropriate specialist, and currently meeting the American College of Rheumatology 1990 criteria
Symptoms for at least 48 months with no recent remission of symptoms to any degree

Who cannot join

Developmental disabilities, or significant psychological disorder (except depression and anxiety disorders) for which treatment has become necessary
A history of chronic infection or chronic condition such as lupus, rheumatoid arthritis, Parkinson's Disease, multiple sclerosis, hepatitis, history of meningo-encephalitis, polio, seizures, or metastatic cancer
Current pregnancy, or plans to become pregnant during the study period.
Any other condition deemed to pose a risk to the patient at the discretion of the investigators
Exposure to other neurostimulation systems, or electroconvulsive therapy
Any implantable electronic device
Any present or previous litigation regarding their physical condition

Trial locations and contacts

1 site in 1 country.

United States1 site

McLaren Regional Medical Center
Flint, Michigan, 48532

Other trials in United States

About this study

Read the detailed description

There is increasing acceptance that pain in fibromyalgia is a result of dysfunctional sensory processing in the spinal cord and brain. Electrical cortical stimulation is a device-based form of therapy that is increasingly being considered as an adjuvant to current medical modalities for the treatment of chronic pain conditions such as fibromyalgia. The investigators propose that stimulation of cortical areas believed to be involved in dysfunctional sensory processing may have a beneficial influence on fibromyalgia symptoms.

The aim of this randomized double blind, placebo controlled study is to evaluate the efficacy, safety, and tolerability of noninvasive cortical stimulation in the management of fibromyalgia symptoms. More specifically, an active treatment group of subjects will receive the study's cortical stimulation protocol twice a week for 11 weeks and will be evaluated within 14 days following end of treatment, for a total timeframe of 13 weeks. In comparison, a similar group of subjects will receive the same treatment protocol without the actual stimulation signal being applied. The signal utilized is a modulated form that permits very low-intensity signals to pass through outer tissues with less attenuation due to tissue impedance. The signals are of a sufficiently low strength that they are below the level of perception. Hence subjects cannot feel the signal, and are therefore blinded to treatment arm. Investigators and clinical staff are also blinded. Outcome measures include post-treatment to baseline changes in tender points, sleep characteristics as measured by visual analog scales, and outcomes instruments including the Fibromyalgia Impact Questionnaire.

Conditions: Fibromyalgia
Being tested: Noninvasive cortical electrical stimulation, Sham treatment
Keywords: fibromyalgia, noninvasive, electrical, cortical, stimulation, pain, brain, tender point
Medical subject headings: Fibromyalgia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Noninvasive cortical electrical stimulationDevice
Also called NeuroPoint
Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
Sham treatmentDevice
Also called NeuroPoint
Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.

Study groups in NCT01180244
Study group	Role	What they receive
Active treatment	Active comparator	Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device Receives: Device: Noninvasive cortical electrical stimulation
Placebo group	Placebo comparator	Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device Receives: Device: Sham treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Tender Point Pain Threshold
Tender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of "less pain" sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome).
Measured: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment

Secondary outcomes (4)

Change in Number of Positive Tender Points
The number of positive tender points ranges from 0-18, and are defined per criteria set forth by the American College of Rheumatology and based on dolorimetry measurements made on 18 prescribed tender point locations. A tender point is considered "positive" if less than 4 kilograms per centimeter squared pressure is required to elicit a painful response. The change in number of positive tender points is determined by subtracting the number of positive tender points at baseline from the number of positive tender points at end of treatment. Thus, a negative number represents pain improvement (i.e. better outcome), whereas a positive number represents a worsening of pain (i.e. worse outcome).
Measured: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Change in Fibromyalgia Impact Questionnaire Overall Score
The Fibromyalgia Impact Questionnaire yields a score ranging from 0 to 100, with higher scores representing a greater impact or level of symptoms. The change in Fibromyalgia Impact Questionnaire is determined by subtracting scores at baseline from scores at end of treatment. Thus negative numbers represent symptom improvement (i.e. a better outcome) and positive numbers represent symptom worsening (i.e. a worse outcome).
Measured: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale
The Fibromyalgia Impact Questionnaire includes a pain visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater pain. The change in Fibromyalgia Impact Questionnaire pain visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents pain improvement (i.e. a better outcome), while a positive value represents pain worsening (i.e. a worse outcome).
Measured: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale
The Fibromyalgia Impact Questionnaire includes a sleep visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater difficulty with sleep. The change in Fibromyalgia Impact Questionnaire sleep visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents sleep improvement (i.e. a better outcome), while a positive value represents sleep worsening (i.e. a worse outcome).
Measured: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2002Jul 2008

First posted12 Aug 2010 (estimated)
Study startJan 2002
Primary completionJan 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01180244
Sponsor's protocol ID: 113
Status last verified: May 2014
First submitted: 10 Aug 2010
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients
ClinicalTrials.gov ID: NCT01180244
Acronym / sponsor ID: 113
Conditions: Fibromyalgia
Keywords: fibromyalgia, noninvasive, electrical, cortical, stimulation, pain, brain, tender point
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: McLaren Regional Medical CenterUniversity, hospital or other
Collaborators: Kettering University
Study start: Jan 2002
Primary completion: Jan 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 12 Aug 2010 (estimated)
Results: Posted 30 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active treatment	Active comparator	Device: Noninvasive cortical electrical stimulationSubjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Placebo group	Placebo comparator	Device: Sham treatmentSubjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 18 through 65 years
An ability to read and comprehend English
Completion of a minimum of grade 8 education
Diagnosis of fibromyalgia in 1999 or earlier, by a rheumatologist or appropriate specialist, and currently meeting the American College of Rheumatology 1990 criteria
Symptoms for at least 48 months with no recent remission of symptoms to any degree

Key exclusion criteria (7 listed)

Developmental disabilities, or significant psychological disorder (except depression and anxiety disorders) for which treatment has become necessary
A history of chronic infection or chronic condition such as lupus, rheumatoid arthritis, Parkinson's Disease, multiple sclerosis, hepatitis, history of meningo-encephalitis, polio, seizures, or metastatic cancer
Current pregnancy, or plans to become pregnant during the study period.
Any other condition deemed to pose a risk to the patient at the discretion of the investigators
Exposure to other neurostimulation systems, or electroconvulsive therapy

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
Noninvasive cortical electrical stimulationAlso: NeuroPointSubjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.	Device	Active treatment
Sham treatmentAlso: NeuroPointSubjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.	Device	Placebo group

Primary outcome

Change in Tender Point Pain Threshold
Time frame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Tender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of "less pain" sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome).

4 secondary outcomes

Change in Number of Positive Tender Points
Time frame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Change in Fibromyalgia Impact Questionnaire Overall Score
Time frame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale
Time frame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale
Time frame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment

Results and safety

Results posted to the registry on 30 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment	45	39
Placebo Group	46	38

Primary outcome: Change in Tender Point Pain Threshold

Time frame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment. Mean (Standard Deviation). Unit: units on a scale

Measure	Active Treatment n = 39	Placebo Group n = 38
Value	19.6 (8.4)	-3.2 (9.4)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Total timeframe 13 weeks: 11 weeks of treatment with outcome assessed within 14 days following end of treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment	0 of 45 (0%)	0 of 45 (0%)	Not reported
Placebo Group	0 of 46 (0%)	0 of 46 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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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.

Jeffrey B Hargrove, PhD principal investigator

Kettering University

Susan J Smith, MD principal investigator

McLaren Regional Medical Center

Sunil Nagpal, MD principal investigator

McLaren Regional Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Noninvasive cortical electrical stimulation in people with Fibromyalgia, run by McLaren Regional Medical Center at 1 site in United States.

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 5 inclusion and 7 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 9 Jun 2014. 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 United States. 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?

Yes. Results are posted in the registry (first posted 30 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Tender Point Pain Threshold (time frame: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment). 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 NCT01180244.

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 9 Jun 2014.