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

Neck Pain Clinical Trial

— SLEEP/MAG  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00445133
• Other study ID #: 00781440
• Status: Recruiting
• Phase: Phase 4
• First received: March 6, 2007
• Last updated: September 26, 2007
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: September 2007
• Source: Weintraub, Michael I., MD, FACP, FAAN
• Contact: Michael I. Weintraub, MD
• Phone: 914-941-0788
• Email: miwneuro[@]pol.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Neck Pain
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Magnetic Sleep Pad

Locations

Country	Name	City	State
United States	Dr. Michael I . Weintraub	Briarcliff Manor	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weintraub, Michael I., MD, FACP, FAAN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Pain scores/Pittsburgh Sleep scores/Insomnia sleep scores/SF 15 pain descriptor scores/PGIC/
Secondary	Autonomic Nerve Functions