Magnets in the Treatment of Sciatica

June 23, 2006 updated by: National Institute of Dental and Craniofacial Research (NIDCR)

Static Magnets In The Treatment of Sciatica

Despite much popularity among the public, magnetic devices used for the treatment of various musculoskeletal and neuropathic pain syndromes have been the subject of few randomized controlled trials.

We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This study will include 52 men and women of all ethnic backgrounds between the ages of 28 and 75 who have had signs and symptoms of sciatica for 3 months or more.

This is a double-blind, randomized, placebo-control, two phase study. In the first phase, after one week baseline, subjects will be randomized to 4 different treatments in a cross-over design. These 4 treatments which will last two weeks each are: 1 magnetic device positioned in 2 different ways along the spinal axis (up-down along the lumbo-sacral spine and left-right across the lumbo-sacral spine), a sham device of similar configuration and a no treatment control. The length of phase I will be 8 weeks. At the end of this phase, codes will be broken to select the magnetic device associated with the greatest amount of pain score reduction. During the second phase which will also be double-blinded, subjects will be randomized to wear the selected magnetic device and sham in a cross-over design. Each of the 2 periods will be 5 weeks in duration. The primary outcome measures will be the daily pain score in the leg. Daily pain level in the low back and the back and leg combined in addition to the patients' quality of life and activities of daily living will be secondary outcome measures as assessed by the SF 36, Oswestry, and Beck depression inventory.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite much popularity among the public, magnetic devices used for the treatment of various musculoskeletal and neuropathic pain syndromes have been the subject of few randomized controlled trials.

We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This study will include 52 men and women of all ethnic backgrounds between the ages of 28 and 75 who have had signs and symptoms of sciatica for 3 months or more.

This is a double-blind, randomized, placebo-control, two phase study. In the first phase, after one week baseline, subjects will be randomized to 4 different treatments in a cross-over design. These 4 treatments which will last two weeks each are: 1 magnetic device positioned in 2 different ways along the spinal axis (up-down along the lumbo-sacral spine and left-right across the lumbo-sacral spine), a sham device of similar configuration and a no treatment control. The length of phase I will be 8 weeks. At the end of this phase, codes will be broken to select the magnetic device associated with the greatest amount of pain score reduction. During the second phase which will also be double-blinded, subjects will be randomized to wear the selected magnetic device and sham in a cross-over design. Each of the 2 periods will be 5 weeks in duration. The primary outcome measures will be the daily pain score in the leg. Daily pain level in the low back and the back and leg combined in addition to the patients' quality of life and activities of daily living will be secondary outcome measures as assessed by the SF 36, Oswestry, and Beck depression inventory.

Study Type

Interventional

Enrollment

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Dental and Craniofacial Research (NIDCR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

    1. Low back pain of 3 months duration or longer present at least 5 out of 7 days a week
    2. Age between 28-80 at the start of the study
    3. Men and women of all ethnicities
    4. Signs and symptoms of lumbar radiculopathy. In this study chronic lumbar radicular signs and symptoms are defined as pain located in the lower lumbar spine corresponding to L1 and below for at least 3 months with radicular characteristics, i.e. pain described as sharp, burning, with numbness and/or tingling.
    5. Ability to understand the study measures and mentally capable to give consent to participate in the study (based on an 8th grade education level)
    6. Willingness to refrain from making changes in non-study medications taken for sciatica
    7. Patients with failed back syndrome.
    8. Pain level of at least 4/10 on average on a scale of 0 to 10 for the past month
    9. Pain not attributable to malignancy, inflammatory arthritis such as rheumatoid arthritis, or infection by previous examinations or by laboratory testing
    10. Patients' agreement to keeping a log of their pain level and documentation of compliance with wearing of back device.
    11. Patients' agreement not to make changes in pain medication type of dosing during the study.
    12. Women of reproductive age agreeing to undergo a pregnancy test at baseline.

EXCLUSION CRITERIA:

  1. Patients with pacemakers
  2. Patients with mechanical heart pumps
  3. Pregnancy or breast feeding
  4. Presence of pain of greater intensity in any other location than the low back or the leg
  5. History of fibromyalgia as described by Wolfe F et al. (1990) (a minimum of 11 out of 18 points of tenderness must be present to satisfy criteria for fibromyalgia)
  6. History of spinal unstability (as defined by X-ray, CT scan or MRI of grade II spondylolisthesis or greater)
  7. Cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits
  8. Unwillingness to use adequate contraception excluding oral contraceptive medications (such as barrier methods with spermicide simultaneously) for women
  9. Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease
  10. History of inflammation arthritis (rheumatoid arthritis, SLE)
  11. Presence of active cancer
  12. History of spinal infection
  13. Patients s/p spinal fusion with spinal rods over the lower lumbar spine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Daily overall pain level, pain in the low back and pain in the lower extremities will be rated on a scale of 0 to 10.

Secondary Outcome Measures

Outcome Measure
Baseline and end of period 1 and 2 of Phase II: Pain symptoms, Pain level with walking, Use of pain meds, Use of other non-medication treatments, questionnaire: SF 36, Oswestry and Beck Depression, Days of disability. End of Study: Patient preference.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

August 17, 2002

First Submitted That Met QC Criteria

August 17, 2002

First Posted (Estimate)

August 19, 2002

Study Record Updates

Last Update Posted (Estimate)

June 26, 2006

Last Update Submitted That Met QC Criteria

June 23, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020274
  • 02-D-0274

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on Magnets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe