Magnets in the Treatment of Sciatica
Condition: Low Back Pain; Sciatica
MeSH terms: Sciatica; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): Magnets
Intervention type(s): Device
Primary purpose: Treatment
Keywords: Pain; Low Back; Radiculopathy; Electromagnetic Treatment; Back Device; Sciatica; Low Back Pain