Evaluation of Magnetic Fields to Treat Fibromyalgia

A Randomized, Double-blind, Placebo-controlled Evaluation of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Fibromyalgia: Pilot Study Protocol

The purpose of this study is to see if a device called the Resonator can help to reduce pain and improve aspects of health and quality of life for people with fibromyalgia.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: magnetic therapy protocol A; Device: magnetic therapy Protocol B; Device: placebo therapy

Detailed Description

The purpose of this pilot study is to assess the efficacy of the Resonator device as an adjunctive therapy to reducing pain and improving aspects of health and quality of life that are relevant to individuals with fibromyalgia.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current diagnosis of fibromyalgia made by the study Principal Investigator (PI) according to the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia.
• Rating of current Degree of Pain on the 0-10 Numeric Pain Intensity Scale of 4 or greater.
• Subject's use of pain relief medication(s) has been stable over the past 30 days, and subject is willing and able to maintain pre-existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
• Subject's use of insomnia medication(s) has been stable over the past 30 days, and subject is willing and able to maintain this existing use of insomnia medication(s) as his or her sole insomnia relief medication(s), as needed, throughout study participation.
• Subject has been on current (or no) medication regimen, unchanged for at least 30 days prior to study enrollment, and is willing and able to maintain that regular medication regimen, unchanged, throughout study participation.
• Willing and able to refrain from use of tender point injections throughout study participation.
• Willing and able to abstain from partaking in other/new treatments to improve fibromyalgia symptoms during study participation.
• Adequate contraceptive measures for female subjects. > 18 years of age or older.
• Male or female.

Exclusion Criteria:

• Any factors that might prevent the subject from completing a full course of therapy with the Resonator™ device, or from attending any of the scheduled study visits, or from completing any of the study measures.
• Subject suffers from co-existent chronic pain condition(s) of non-fibromyalgia origin, such as osteoarthritis, low back pain, neck pain, painful diabetic neuropathy and postherpetic neuropathic pain, that cannot be distinguished in severity and/or in type/sensation of pain from the pain originating from the subject's condition of fibromyalgia.
• Any other significant comorbidities that might impact the ability to evaluate the subject's satisfaction of the ACR 1990 Criteria for the Classification of Fibromyalgia, or for the subject to complete any of the study assessment tools.
• Tender point injections received within the prior one month.
• Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, substance abuse).
• Known inflammatory rheumatic disease.
• Epilepsy/history of seizures/taking medication for epilepsy.
• HIV and other autoimmune disorders.
• Active cancer or treatment for cancer within last 6 months.
• Active infection(s).
• History of ECT
• Uncontrolled Hypertension.
• Advanced Pulmonary Disease.
• Unstable cardiac disease.
• Prosthetics or implants comprised of ferrous metals.
• Pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.
• Consumption of more than 21 alcoholic drinks per week.
• Pregnant, breast feeding, or planning pregnancy prior to end of study participation.
• Developmental disability or other cognitive impairment that would in the judgment of the PI impair adequate comprehension of the informed consent form or complete any of the study-related activities.
• Worker's compensation, receipt of disability or present/past litigation for monetary compensation pertaining to subject's fibromyalgia condition.
• Participation in other research within 30 days of study enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resonator Protocol A	Device: magnetic therapy protocol A; Application of magnetic fields using the Resonator device Protocol A
Active Comparator: Resonator Protocol B; Application of magnetic fields using the Resonator device Protocol B	Device: magnetic therapy Protocol B; Application of magnetic fields using the Resonator device Protocol B
Placebo Comparator: Inactive Resonator	Device: placebo therapy; Application of inactive magnetic fields using the Resonator device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.	Minimum scale value is '0' which represents 'no pain at all' and is the best outcome. Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome.	2 weeks (baseline to end of treatment)

Collaborators and Investigators

• Sponsor: pico-tesla Magnetic Therapies, LLC
• Investigators: Principal Investigator: Jerry I Jacobson, Ph.D, D.M.D.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 16, 2010
• First Posted (Estimate): December 17, 2010

Study Record Updates

• Last Update Posted (Estimate): July 1, 2011
• Last Update Submitted That Met QC Criteria: June 6, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Fibromyalgia; Pain associated with Fibromyalgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 10242-01