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

NCT ID: NCT00445133

Last Updated: 2007-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-12-31

Brief 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.

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.

Conditions

Back Pain; Neck Pain; Sleep Initiation and Maintenance Disorders

Keywords

Neck Pain/Lumbar pain/Magnets/sleep deficiency/ insomnia/

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Magnetic Sleep Pad

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weintraub, Michael I., MD, FACP, FAAN

INDIV

Sponsor Role: lead

Principal Investigators

Michael I. Weintraub, MD

Role: PRINCIPAL_INVESTIGATOR

Phelps Memorial Hospital

Locations

Dr. Michael I . Weintraub

Briarcliff Manor, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael I. Weintraub, MD

Role: CONTACT

Phone: 914-941-0788

Email: miwneuro@pol.net

Susan E Wolert

Role: CONTACT

Phone: 914-941-0788

Email: miwneuro@pol.net

Facility Contacts

Michael I Weintraub, MD

Role: primary

Susan E Wolert

Role: backup

Other Identifiers

00781440

Identifier Type: -

Identifier Source: org_study_id