Evaluation of Magnetic Fields to Treat Fibromyalgia

NCT01262131 | Completed Phase 2 Results

• 1 other identifier: 10242-01
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Pain associated with Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Resonator Protocol A

ACTIVE COMPARATOR

Device: magnetic therapy protocol A

Resonator Protocol B

ACTIVE COMPARATOR

Application of magnetic fields using the Resonator device Protocol B

Device: magnetic therapy Protocol B

Inactive Resonator

PLACEBO COMPARATOR

Device: placebo therapy

Interventions

magnetic therapy protocol A DEVICE

Application of magnetic fields using the Resonator device Protocol A

Resonator Protocol A

magnetic therapy Protocol B DEVICE

Application of magnetic fields using the Resonator device Protocol B

Resonator Protocol B

placebo therapy DEVICE

Application of inactive magnetic fields using the Resonator device

Inactive Resonator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• pico-tesla Magnetic Therapies, LLC: lead

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Allen S. Braswell CEO
• Organization: Pico-Tesla Magnetic Therapies, LLC

abraswell@pico-tesla.com

303 795-3222

Study Officials

• Jerry I Jacobson, Ph.D, D.M.D.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 1, 2011
• Results First Posted: July 1, 2011

Record last verified: 2011-06