This 19-week study will evaluate magnets of very low power to treat sciatica (also referred to as lumbago, sciatica, or lumbar radicular pain). Some evidence suggests that magnets can alleviate pain associated with muscle, bone, and nerve problems.

Individuals between 30 and 70 years of age who have had sciatica (sharp, shooting pains in the leg) daily for at least 3 months may be eligible for this study. The pain must be moderate to severe, occur on a daily basis, and be due to either disc problems or degeneration of the spine. Patients with pain in the buttock or posterior thigh without sciatica may also qualify if they have irritation of the lumbar (lower spine) nerve roots or if imaging studies such as magnetic resonance imaging (MRI) reveal a disc compressing the lumbar nerves on the same side as the pain. Candidates will be screened with a medical history, physical and neurological examinations, blood tests, pain evaluation, collection of demographic information, and possibly MRI. They will fill out questionnaires regarding pain, daily function, and psychological well being.

The study has two phases, consisting of four 2-week periods in phase 1 and two 5-week periods in phase 2.

- Phase 1: During two of the 2-week periods, subjects wear an elastic binder back support device with magnets sewn into them - one with the magnets aligned in the direction of the spine; the other with the magnets placed across the spine. During another period, subjects wear a dummy device that looks like a real magnet but has no actual magnetic force; in another, they wear no device at all. The magnets are worn at least 12 hours a day.

- Phase 2: The subject wears the preferred magnet (real or sham) from phase 1 during one of these 5-week periods, and a dummy device during the other. Participants who did not find any of the magnets helpful in phase 1 may continue, nevertheless, with phase 2 and be assigned a magnet and sham device by the investigators.

Participants may continue taking their regular pain medicines throughout the study's duration. They will keep a pain log during both phases, rating their pain on a scale of 0 to 10, and a record of side effects experienced with each period of the study. They will also keep a record of procedures, such as injections and manipulations, they undergo during the study to control pain flare-ups. Clinic visits will be scheduled as follows:

- Visit 1: for screening and baseline studies before starting phase 1; participants may also come to the clinic after each 2-week period in phase 1 to exchange devices, or the devices may be mailed to the participant

- Visit 2: at the end of phase 1 for an interview about the magnet treatments and to indicate the preferred treatment

- Visit 3: at the end of the first phase 2 5-week period for a brief neurological examination, interview regarding treatment satisfaction and side effects, and completion of questionnaires

- Visit 4: at the end of the second phase 2 5-week period for the same procedures as visit 2

During each visit, participants will have sensory testing, in which a pin is placed on the surface of the skin. This test does not cause any discomfort. At the end of the study, participants will be given the device that helped them, if any.

Condition	Treatment or Intervention	Phase
Low Back Pain Sciatica	Device: Magnets	Phase II

Further Study Details: 

Expected Total Enrollment:  75

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 30 and 70 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.

Genders Eligible for Study:  Both

Criteria

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 30-80 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 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

Maryland
      National Institute of Dental And Craniofacial Research (NIDCR), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States

Study ID Numbers:  020274; 02-D-0274
Record last reviewed:  July 30, 2004
Last Updated:  November 23, 2004
Record first received:  August 17, 2002
ClinicalTrials.gov Identifier:  NCT00044109
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08