Clinical Trial Summary and Case Report

Control Study

Controlled clinical studies were conducted in 1983 and 1989 in two clinical sites. The study was published in Environmental Medicine in 1991. The study was performed to assess the effectiveness of QuadraBloc™ in reducing lower back and knee pain in 54 patients at both sites. The study was a double blind, randomized, cross over study, using both active MagnaBlocs™ and inactive MagnaBlocs™ and neither the patient nor doctor knew which was which. Subjects were treated with either the QuadraBloc™ or the dummy device on two separate occasions. The assignment of devices was randomized. The pain relief due to the “placebo effect” (the psychological effect), of the inactive device, was about 25 percent. When these “Placebo effects” are subtracted, the effect of QuadraBloc™ over and above placebo was 20% for back pain, and 34% for knee pain. This data is summarized from Holcomb, et al (1991): “Biomagnetics in the Treatment of Human Pain-Past, Present, and Future” Environmental Medicine 08:24-30.

To put this data in perspective, one should reflect on the fact that morphine (the gold standard of pain relief) has been reported in one study to be only 12% more erective than placebo (plain water) when give for pain following surgical procedures. In other studies the placebo effect from morphine may run from as low as 30% up to 88%.

Clinical Trials & Reports

Effects of Non Uniform Static Magnetic Fields on the Rate of Myosin Phosphorylation

Measurement and Analysis of Static Magnetic Fields That Block Action Potentials in Cultured Neurons

Two Configurations of Static Magnetic Fields for Treating Rheumatoid Arthritis of the Knee: A Double-Blind Clinical Trial

Blockade of Sensory Meuron Action Potentials by a Static Magnetic Field in the 10 mT Range

Effects of Steady Magnetic Fields on Action Potentials of Sensory Neurons in Vitro

Efficacy of a Static Magnetic Device Against Knee Pain Associated with Inflammatory Arthritis

Static Magnetic Field Therapy for Pain in the Abdomen and Genitals

Biomagnetics in the Treatment of Human Pain- Past, Present, Future

Conference to Probe Magnetic Therapy Advances

A static magnetic field modulates severity of audiogenic seizures and anticonvulsant effects of phenytoin in DBA/2 mice

Effects of static magnets on chronic knee pain and physical function: a double-blind study

Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study.

Effects of static magnetic fields on the voltage-gated potassium channel currents in trigeminal root ganglion neurons.

Effects of static magnets on chronic knee pain and physical function: a double-blind study.

Double-blind placebo-controlled trial of static magnets for the treatment of osteoarthritis of the knee: results of a pilot study.

Influence of strong static magnetic fields on primary cortical neurons

Static magnetic field-induced anti-nociceptive effect and the involvment of capsaicin-sensitive sensory nerves in this mechanism

Influence of strong static magnetic fields on primary cortical neurons

Optimization of static magnetic field parameters improves analgesic effect in mice

Treatment of wrist and hand fractures with natural magnets: preliminary report

Devices for Gradient Static Magnetic Field Exposure

Abstracts

Temperature Sensitivity of Effects of Static Magnetic Fields on Action Potentials of Sensory Neurons in Culture. Soc. Neurosci. Abs. 16: 883, 1990. Holcomb, RR; Wamil, AW; Pickett, JD and McLean, MJ:

Temperature Dependence of Magnetic Field Effects on Subtypes of Sensory Neurons in Vitro. Soc. Neurosci. Abs. 17: 1256, 1991. Holcomb, RR; Wamil, AW; Picket, JD and McLean, MJ.

Blockade of Action Potentials of Sensory Neurons by an Array of Four Permanent Magnets of Alternating Polarity. Abstracts, 15th Annual Meeting of the Bioeletromagnetics Society, Los Angeles, CA, June 13-17, 1993. McLean, MJ; Holcomb, RR; Wamil, AW; Cavopol, AV.

Magnetic Resonance Detection and Modeling of Static Fields Produced by Permanent Magnets; First Observations. 16th Annual Meeting of the Bioelectromagnetics Society, Copenhagen, Denmark, June 12-17, 1994. Cavopol, AV; Willcott, RW; Holcomb, RR and McLean, MJ.

Characterization of Certain Static Magnetic Fields Which Block Action Potentials of Sensory Neurons in Cell Culture. 16th Annual Meeting of the Bioelectromagnetics Society, Copenhagen, Denmark, June 12-17, 1994. Cavopol, AV; Wamil, AW; Holcomb, RR and McLean, MJ.

Blockade of Action Potentials and Capsaicin Responses of Cultured Sensory Neurons by a Static Magnetic Field. 16th Annual Meeting of the Bioelectromagnetics Society, Copenhagen, Denmark, June 12-17, 1994. Wamil, AW; Holcomb, RR and McLean, MJ.

Treatment of Wrist Pain in the Work Place with a Static Magnetic Device: Interim Report of Clinical Trial. Second World Congress for Electricity and Magnetism in Biology and Medicine, Bologna, Italy, June 8-13, 1997. McLean, MJ; Holcomb, RR; Torgerson, JE and McCullough, B.

Treatment of Mechanical Low Back Pain with Arrays of Permanent Magnets: A Controlled Study. 20th Annual Meeting of the Bioelectromagnetics Society, St. Pete Beach, FL, June 7 - 13, 1998. Holcomb, RR.

A Static Magnetic Field Slows Kainic Acid-Induced Neuronal Swelling. 21st Annual Meeting of the Bioelectromagnetics Society, Long Beach, CA, McClean, MJ; Holcomb, RR; MacDonald, PW; Sanderson L, and Lombard, K.

Static Magnets and Pain Bibliography

Bjordal, JM, Johnson, MI, et al. Short-term efficacy of Physical Interventions in Osteoarthritis Knee Pain. A Systematic Review and Meta-Analysis of Randomised Placebo-Controlled Trials. BMC Musculoskeletal Disorders 8, 51 (June 22, 2007).

Brown CS, Ling FW, Wan JY, and Pilla AA. Efficacy of Static Magnetic Field Therapy in Chronic Pelvic Pain: A Double-Blind Pilot Study. Am. J. Obstet Gynecol. 187(6), 1581-1587 (2002).

Cavopol AV, Wamil AW, Holcomb RR, and McLean MJ. Measurement and Analysis of Static Magnetic Field that Block Action Potentials in Cultured Neurons.
Bioelectromagnetics 16, 197-206 (1995).

Colbert, AP, Whbeh, H, et al. Static Magnetic Field Therapy: A Critical Review of Treatment Parameters. eCAM 2007 (7 pages).

Coots A, Shi R, and Rosen AD. Effect of a 0.5-T Static Magnetic Field on Conduction in Guinea Pig Spinal Cord. J. Neurol. Sci. 222 (1-2), 55-57 (2004).

Eccles, NK. A Critical Review of Randomized Controlled Trials of Static Magnets for Pain Relief. J. Alternative and. Complementary Medicine 11(3), 495-509 (2005).

Eccles N. Static Magnets Prevent Leg Ulcer Recurrence: Savings for the NHS? Br. J. Community Nurs. 11 (3), S26, @28-30 (2006).

Engstrom S., Markov MS et al. Effects Of Non-Uniform Static Magnetic Fields On The Rate Of Myosin Phosphorylation. Bioelectromagnetics 23 (6), 475-479 (2002).

Engstrom S., Markov MS et al. Devices For Gradient Static Magnetic Field Exposure. Bioelectromagnetics 26 (4) 336-40 (2005).

Gyires K., Zadori ZS, Racz B, and Laszlo J. Pharmacological Analysis of Inhomogeneous Static Magnetic Field-Induced Antinociceptive Action in the Mouse. Bioelectromagnetics, Apr 24 [Epub ahead of print] (2008).

Hinman MR, Ford J, and Heyl H. Effects of Static Magnets on Chronic Knee Pain and Physical Function: A Double-Blind Study. Altern. Ther. Health Med. 8 (4), 50-55 (2002).

Holcomb RR, Worthington WB, McCullough BA, and McLean MJ. Static Magnetic Field Therapy For Pain In The Abdomen And Genitals. Pediatric Neurology 23 (3), 261-264 (2000).

Laszlo J, Reiczigel, J., et al. Optimization of Static Magnetic Field Parameters Improves Analgesic Effect in Mice. Bioelectromag. 28, 615-627 (2007).

Man, D., Man, B. and Plosker H. Influence of Permanent Magnetic Field Therapy on Wound Healing in Suction Lipectomy Patients: A Double-Blind Study. Plastic Reconstructive Surgery 104, 7 (1999).

Markov, MS. Magnetic Field Therapy: A Review. Electromagnetic Biol. Med. 26, 1-23 (2007).

McLean MJ, Holcomb RR, Wamil AW et al. Blockade Of Sensory Neuron Action Potentials By A Static Magnetic Field In The 10 Mt Range. Bioelectromagnetics 16 (1), 20-32 (1995).

McLean M, Engstrom S, and Holcomb R. Static Magnetic Fields for the Treatment of Pain. Epilepsy & Behavior 2, S74-S80 (2001).

McLean M, Engstrom S, and Holcomb R. Magnetic Field Therapy for Epilepsy. Epilepsy & Behavior 2 (3) S81-S87 (2001).

McLean MJ, Engstrom S, Holcomb RR, and Sanchez D. A Static Magnetic Field Modulates Severity Of Audiogenic Seizures And Anticonvulsant Effects Of Phenytoin In DBA/2 Mice. Epilepsy Res 55 (1-2), 105-116 (2003).

Morris, CE and Skalak, TC. Chronic Static Magnetic Field Exposure Alters Microvessel Enlargement Resulting from Surgical Intervention. J. Appl. Physiol. 103, 629-636 (2007).

Morris, CE and Skalak, TC. Acute Exposure to a Moderate Strength Static Magnetic Field Reduces Edema Formation in Rats. Amer. J. Physiol. Nov. 2007.

Pittler, MH and Brown, EM. Static Magnets for Reducing Pain: Systematic Review and Meta-Analysis of Randomized Trials. CMAJ 177(7), 736-742 (2007).

Rosen, AD. Effect of a 125mT Static Magnetic Field on the Kinetics of Voltage Activated Na+ Channels in GH3 Cells. Bioelectromag. 24, 517-523 (2003).

Rosen, AD. Mechanism of Action of Moderate-Intensity Static Magnetic Fields on Biological Systems. Cell Biochem. Biophysics 39 (2), 163-173 (2003).

Rosen MS, and Rosen AD. Magnetic Field Influence on Paramecium Motility. Life Sci. 46 (21), 1509-1515 (1990).

Sandor K, Helyes Z et al. Static Magnetic Field-Induced Anti-nociceptive Effect and the Involvement of Capsaicin-Sensitive Sensory Nerves in this Mechanism. Life Sci. 81 (2), 97-102 (2007).

Segal NA, Huston J, Fuchs H, Holcomb RR, McLean MJ. Efficacy Of A Static Magnetic Device Against Knee Pain Associated With Inflammatory Arthritis. Journal of Clinical Rheumatology 5, 302-4 (1999).

Segal N, Toda Y, Huston J, et al. Two Configurations Of Static Magnetic Fields For Treating Rheumatoid Arthritis Of The Knee: A Double-Blind Clinical Trial. Archives of Physical Medicine and Rehabilitation 82, 1453-60 (2001).

Shen, Jie-Fei, Chao, Yong-Lie, and Du Li. Effects of Static Magnetic Fields on the Voltage-gated Potassium Channel Currents in Trigeminal Root Ganglion Neurons. Neurosci. Letters 415 (2), 164-168 (2007).

Wolsko PM, Eisenberg DM, Simon LS, et al. Double-Blind Placebo-Controlled Trial of Static Magnets for the Treatment of Osteoarthritis of the Knee: Results of a Pilot Study. Altern. Ther. Health Med. 10 (2), 36-43 (2004).