Two configurations of static magnetic fields for treating rheumatoid arthritis of the knee: A double-blind clinical trial

doi:10.1053/apmr.2001.24309

Archives of Physical Medicine and Rehabilitation

Volume 82, Issue 10, October 2001, Pages 1453-1460

https://doi.org/10.1053/apmr.2001.24309 Get rights and content

Abstract

Segal NA, Toda Y, Huston J, Saeki Y, Shimizu M, Fuchs H, Shimaoka Y, Holcomb R, McLean MJ. Two configurations of static magnetic fields for treating rheumatoid arthritis of the knee: a double-blind clinical trial. Arch Phys Med Rehabil 2001;82:1453-60. Objective: To assess the efficacy of a nonpharmacologic, noninvasive static magnetic device as adjunctive therapy for knee pain in patients with rheumatoid arthritis (RA). Design: Randomized, double-blind, controlled, multisite clinical trial. Setting: An American and a Japanese academic medical center as well as 4 community rheumatology and orthopedics practices. Patients: Cohort of 64 patients over age 18 years with rheumatoid arthritis and persistent knee pain, rated greater than 40/100mm, despite appropriate use of medications. Intervention: Four blinded MagnaBloc™ (with 4 steep field gradients) or control devices (with 1 steep field gradient) were taped to a knee of each subject for 1 week. Main Outcome Measures: The American College of Rheumatology recommended core set of disease activity measures for RA clinical trials and subjects' assessment of treatment outcome. Results: Subjects randomly assigned to the MagnaBloc (n = 38) and control treatment groups (n = 26) reported baseline pain levels of 63/100mm and 61/100mm, respectively. A greater reduction in reported pain in the MagnaBloc group was sustained through the 1-week follow-up (40.4% vs 25.9%) and corroborated by twice daily pain diary results (p < .0001 for each vs baseline). However, comparison between the 2 groups demonstrated a statistically insignificant difference (p < .23). Subjects in the MagnaBloc group reported an average decrease in their global assessment of disease activity of 33% over 1 week, as compared with a 2% decline in the control group (p < .01). After 1 week, 68% of the MagnaBloc treatment group reported feeling better or much better, compared with 27% of the control group, and 29% and 65%, respectively, reported feeling the same as before treatment (p < .01). Conclusions: Both devices demonstrated statistically significant pain reduction in comparison to baseline, with concordance across multiple indices. However, a significant difference was not observed between the 2 treatment groups (p < .23). In future studies, the MagnaBloc treatment should be compared with a nonmagnetic placebo treatment to characterize further its therapeutic potential for treating RA. This study did elucidate methods for conducting clinical trials with magnetic devices. © 2001 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation

Section snippets

Magnabloc devices

The MagnaBloc is a nonpharmacologic, noninvasive, quadrapolar static magnetic device with 4 permanent center charged, rare earth magnets arrayed with alternating polarity in a hypoallergenic plastic case. It is approximately 3.5cm in diameter, weighs approximately 30g, and generates magnetic fields of about 190mT over each pole. Much larger time-invariant magnetic fields, such as those produced by magnetic resonance imaging (MRI) devices, have not been shown to be harmful to humans or animals.17

Demographics

The trial enrolled a cohort of 64 patients who presented with knee pain to their rheumatologists from October 1998 through May 1999. The 6 centers participating in the study were: the private rheumatology office of Medical Specialists of Nashville; the Arthritis and Joint Replacement Center at Vanderbilt University Medical Center in Nashville, TN; the Osaka University Medical Center Department of Medicine III; and Yukioka Hospital, Toda Clinic, and Hino Hospital in Osaka, Japan.

Of 64 patients

Discussion

RA is a chronic, progressive inflammatory disease of idiopathic origin. The ACR has established criteria for evaluation of RA patients in clinical trials.²³ We used several assessments in this study, the outcome of which shows that some criteria may be more sensitive than others for assessing knee pain in RA. For example, S-GADA and subjects' assessment of treatment outcome with respect to physical functioning showed significant improvement at 1 week in the MagnaBloc group in comparison with

Conclusion

The results of this randomized, double-blind, controlled, multicenter clinical trial indicate a probable superiority of the magnetic field generated by the MagnaBloc over that produced by a control magnetic device. In this trial, the MagnaBloc was compared with a device that had greatly differing field geometry and maximal field strength. When normalized and analyzed by nonparametric statistical tests, both devices were significantly effective in reducing pain and in improving patients' overall

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^☆: Supported by the Vanderbilt University Medical Scholars Program and the Holcomb Medical Research Institute.

^☆☆: An organization with which one or more of the authors is associated has received or will receive financial benefits from a commercial party having a direct financial interest in the results of the research supporting this article.

^★: Reprint requests to Michael J. McLean, MD, PhD, 437 MCS Vanderbilt University Medical Center, Nashville, TN 37232, e-mail:[email protected].

^★★: Suppliers

^♢: a. MagnaBloc, 1500 21st Ave S, Ste 1516, Nashville, TN 37212.

^♢♢: b. 3M, 3M Center, St Paul, MN 35144-1000.

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ArticlesTwo configurations of static magnetic fields for treating rheumatoid arthritis of the knee: A double-blind clinical trial☆,☆☆,★,★★,♢,♢♢

Abstract

Section snippets

Magnabloc devices

Demographics

Discussion

Conclusion

Arch Phys Med Rehabil

Life Sci

Pain

Pain

Biochem Biophys Acta

Nonsteroidal anti-inflammatory drug use and increased risk for peptic ulcer disease in elderly persons

Ann Intern Med

Nonsteroidal anti-inflammatory drug-associated azotemia in the very old

JAMA

Magnetic healing, quackery, and the debate about the health effects of electromagnetic fields

Ann Intern Med

A double-blind trial of the clinical effects of pulsed electromagnetic fields in osteoarthritis

J Rheumatol

Magnetic mattress pad use in patients with fibromyalgia: a randomized double-blind pilot study

Discovery of magnetic health: a health care alternative

Flexible magnets are not effective in decreasing pain perception and recovery time after muscle microinjury

J Athl Train

Bipolar permanent magnets for the treatment of chronic low back pain

JAMA

Magnetic biostimulation in painful diabetic peripheral neuropathy: a novel intervention—a randomized, double-placebo crossover study

Am J Pain Manage

Biomagnetics in the treatment of human pain—past, present, future

Environ Med

Efficacy of a static magnetic device against knee pain associated with inflammatory arthritis

J Clin Rheumatol

Articles
Two configurations of static magnetic fields for treating rheumatoid arthritis of the knee: A double-blind clinical trial☆,☆☆,★,★★,♢,♢♢