Evaluation of Magnetic Fields to Treat Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier:
NCT01262131
First received: December 14, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Device: magnetic therapy protocol A
Device: magnetic therapy Protocol B
Device: placebo therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by pico-tesla Magnetic Therapies, LLC:

Primary Outcome Measures:
  • Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale. [ Time Frame: 2 weeks (baseline to end of treatment) ] [ Designated as safety issue: No ]

    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.



Enrollment: 13
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262131

Sponsors and Collaborators
pico-tesla Magnetic Therapies, LLC
Investigators
Principal Investigator: Jerry I Jacobson, Ph.D, D.M.D.
  More Information

No publications provided

Responsible Party: Allen S. Braswell CEO, pico-tesla Magnetic Therapies, LLC, Pico-Tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier: NCT01262131     History of Changes
Other Study ID Numbers: 10242-01
Study First Received: December 14, 2010
Results First Received: May 13, 2011
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by pico-tesla Magnetic Therapies, LLC:
Fibromyalgia
Pain associated with Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 02, 2014