NCT00445133

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 27, 2007

Status Verified

September 1, 2007

First QC Date

March 6, 2007

Last Update Submit

September 26, 2007

Conditions

Back PainNeck PainSleep Initiation and Maintenance Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • VAS Pain scores/Pittsburgh Sleep scores/Insomnia sleep scores/SF 15 pain descriptor scores/PGIC/

Secondary Outcomes (1)

  • Autonomic Nerve Functions

Interventions

Magnetic Sleep PadDEVICE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Michael I . Weintraub

Briarcliff Manor, New York, 10510, United States

RECRUITING

MeSH Terms

Conditions

Back PainNeck PainSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Michael I. Weintraub, MD

    Phelps Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael I. Weintraub, MD

CONTACT

914-941-0788miwneuro@pol.net

Susan E Wolert

CONTACT

914-941-0788miwneuro@pol.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 8, 2007

Study Start

February 1, 2007

Study Completion

December 1, 2007

Last Updated

September 27, 2007

Record last verified: 2007-09

Locations

US(1)