Protocol Number: 02-D-0274

Title:

Static Magnets In The Treatment of Sciatica

Number:

02-D-0274

Summary:

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.

Sponsoring Institute:

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Pain

Low Back

Radiculopathy

Electromagnetic Treatment

Back Device

Recruitment Keywords:

Sciatica

Low Back Pain

Conditions:

Low Back Pain

Sciatica

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Alfano AP, Taylor AG, Foresman PA, Dunkl PR, McConnell GG, Conaway MR, Gillies GT. Static magnetic fields for treatment of fibromyalgia: a randomized controlled trial. J Altern Complement Med. 2001 Feb;7(1):53-64. PMID: 11246937

Blank M, Soo L. Electromagnetic acceleration of electron transfer reactions. J Cell Biochem. 2001 Mar 26;81(2):278-83.

PMID: 11241667

Blank M, Soo L. Optimal frequencies for magnetic acceleration of cytochrome oxidase and Na,K-ATPase reactions. Bioelectrochemistry. 2001 Mar;53(2):171-4. PMID: 11339304

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Warren Grant Magnuson Clinical Center (CC)
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Bethesda, Maryland 20892. Last update: 10/23/2004