Magnets in the Treatment of Sciatica

Completed · Phase 2

Conditions studied: Low Back Pain, Sciatica

In brief

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.

Key facts

Study ID

NCT00044109

Run by

National Institute of Dental and Craniofacial Research (NIDCR)

People needed

75

Starts

2002-08-01

Expected to finish

2006-06-01

Last updated by the study team

2006-06-26

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with pacemakers
• Patients with mechanical heart pumps
• Pregnancy or breast feeding
• Presence of pain of greater intensity in any other location than the low back or the leg
• 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)
• History of spinal unstability (as defined by X-ray, CT scan or MRI of grade II spondylolisthesis or greater)
• Cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits
• Unwillingness to use adequate contraception excluding oral contraceptive medications (such as barrier methods with spermicide simultaneously) for women
• Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease
• History of inflammation arthritis (rheumatoid arthritis, SLE)
• Presence of active cancer
• History of spinal infection
• Patients s/p spinal fusion with spinal rods over the lower lumbar spine

Where it is running

• National Institute of Dental And Craniofacial Research (NIDCR) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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