Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine Pain

Last updated: September 26, 2007
Sponsor: Weintraub, Michael I., MD, FACP, FAAN
Overall Status: Trial Status Unknown

Phase

4

Condition

Chronic Pain

Neck Pain

Treatment

N/A

Clinical Study ID

NCT00445133
00781440
  • Ages 18-85
  • All Genders

Study Summary

HYPTHOTHESIS:

The researchers hypothesize that application of active magnetic therapy vs. sham utilized while individuals sleep can reduce neuropathic pain in the spine and improve the quality of sleep. The null hypothesis is that treatment of subjects with spine pain with exposure to permanent/static magnetic fields has no measurable effect on neuropathic pain scores or quality of sleep scores.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female or male subjects age 18-80.

  • Capable of understanding and complying with study protocols.

  • Chronic cervical, thoracic or lumbar pain for at least six months.

  • Sleep difficulties and/or insomnia

Exclusion

Exclusion Criteria:

  • Unable to understand informed consent (mental retardation, psychosis, communicativeimpairment).

  • Cardiac pacemaker or other mechanical internal devices.

  • Tumor in the spine/history of malignancy.

  • Pregnancy.

  • Prior spine surgery

Study Design

Total Participants: 80
Study Start date:
February 01, 2007
Estimated Completion Date:
December 31, 2007

Study Description

DESIGN:

This is a double-blind, randomized, placebo-controlled study which will consist of two treatment groups. Treated subjects will receive a permanent/static magnetic sleeping pad with a nominal strength of less than 1000 Gauss. Control subjects will receive physically identical sleeping pad with a nominal surface field strength of 0 Gauss (placebo). The magnets will be contained in a standard mattress pad and subjects will sleep on the pad. The primary outcome measures will be quality of sleep as well as the daily VAS scores. These are subjective. There will be objective assessment by the quantification of autonomic nervous system (ANS) strengths of the parasympathetic and sympathetic effects from this non-invasive digital study using spectral analysis. Individuals will be evaluated at onset of study and at end of study to look at specifics of range of motion, spasm, radiculitis, etc. Scores will be kept on a monthly basis as well as repeat of ANS testing each month. At the end of the study, individuals will return all forms, be reevaluated by Dr. Weintraub and also will be asked questions regarding PGIC for bias, etc. Additionally heart rate and systolic and diastolic BP readings at rest and with challenge of standing will be recorded at baseline and each visit to determine if there is an anti-hypertensive effect from sleeping on magnetic device. A reduction of 3 mm Hg improves stroke and cardiac risk by a minimum of 4%. No new anti-hypertensive medications will be allowed.

Connect with a study center

  • Dr. Michael I . Weintraub

    Briarcliff Manor, New York 10510
    United States

    Active - Recruiting

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