Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine Pain (SLEEP/MAG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Weintraub, Michael I., MD, FACP, FAAN.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weintraub, Michael I., MD, FACP, FAAN
ClinicalTrials.gov Identifier:
NCT00445133
First received: March 6, 2007
Last updated: September 26, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Back Pain
Neck Pain
Sleep Initiation and Maintenance Disorders
Device: Magnetic Sleep Pad
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine Pain (Sleep/Mag)

Resource links provided by NLM:


Further study details as provided by Weintraub, Michael I., MD, FACP, FAAN:

Primary Outcome Measures:
  • VAS Pain scores/Pittsburgh Sleep scores/Insomnia sleep scores/SF 15 pain descriptor scores/PGIC/

Secondary Outcome Measures:
  • Autonomic Nerve Functions

Estimated Enrollment: 80
Study Start Date: February 2007
Estimated Study Completion Date: December 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Criteria:

  • Unable to understand informed consent (mental retardation, psychosis, communicative impairment).
  • Cardiac pacemaker or other mechanical internal devices.
  • Tumor in the spine/history of malignancy.
  • Pregnancy.
  • Prior spine surgery
  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: NCT00445133

Contacts
Contact: Michael I. Weintraub, MD 914-941-0788 miwneuro@pol.net
Contact: Susan E Wolert 914-941-0788 miwneuro@pol.net

Locations
United States, New York
Dr. Michael I . Weintraub Recruiting
Briarcliff Manor, New York, United States, 10510
Contact: Michael I Weintraub, MD    914-941-0788    miwneuro@pol.net   
Contact: Susan E Wolert    914-941-0788    miwneuro@pol.net   
Principal Investigator: Michael I. Weintraub, MD         
Sponsors and Collaborators
Weintraub, Michael I., MD, FACP, FAAN
Investigators
Principal Investigator: Michael I. Weintraub, MD Phelps Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00445133     History of Changes
Other Study ID Numbers: 00781440
Study First Received: March 6, 2007
Last Updated: September 26, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Weintraub, Michael I., MD, FACP, FAAN:
Neck Pain/Lumbar pain/Magnets/sleep deficiency/ insomnia/

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Back Pain
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014