TREATMENT OF OSTEOARTHRITIS WITH A NEW BROADBAND PEMF SIGNAL (QRSâ Salut 1 ). W. Pawluk, Advanced Magnetic Research Institute of the Delaware Valley, Rancocas, New Jersey and School of Medicine, Johns Hopkins University; Turk Z, Maribor General Hospital, Slovenia; Fischer G, University Graz; Kobinger W, University Graz 

Presented at the Bioelectromagnetic Society (BEMS) Meeting Quebec, Canada; June 25-27, 2002

INTRODUCTION:  Osteoarthritis is a debilitating joint disease, which affects about 40 million people in the United States of America. Osteoarthritis of the knee is a leading cause of disability in the elderly. Pharmacologic management is often ineffective. Several clinical studies using electromagnetic fields to treat osteoarthritis have been reported. One, by Trock DH et al, reported a randomized, double blind clinical trial to treat OA of the knee and cervical spine with a PEMF system. The magnetic field was a maximum 25 G; frequency varying from 5 to 24 Hz. The waveform was quasi-rectangular with abruptly rising and deteriorating waveform with a pulse burst duty cycle of up to 0.8 and up to 20 pulses per burst, depending on the frequency. There were 18 half-hour treatments in patients with OA 86 knee and 81 patients cervical spine. Evaluations were made at baseline, midway, end of treatment, and one month after completion. Tests showed extremely significant changes from baseline for the treated patients in both knee and cervical spine studies at the end of treatment and the one-month follow up observations. It is the purpose of this work with the QRS Salut 1 system to describe the results of a double blind knee osteoarthritis clinical study using a novel pulsing electromagnetic field (QRS, Body Fields, Des Plaines, IL). The QRS system has been primarily used in Europe where several pilot studies suggest benefits or actions in ion migration, vasodilatation, osteoporosis and osteoarthritis.  METHODS: This was a randomized double blind knee osteoarthritis (KOA) study involving 36 placebo/35 active patients. 28% were male. Mean age was 60 ± 10 years.  35% were clearly overweight. 83% had both knees affected. Subjects were entered if they had KOA with or without other comorbidities and excluded only if they could not complete the course of treatment. The QRS device induces a complex EMF waveform via large body size coils within a thin mattress or pillow pad. The coils are driven by an external generator with 10 strength settings.  Peak magnetic field at the coil is approximately 400 µT within a frequency range of 1-100 kHz.  The primary waveform is sawtooth-like, having a 10µsec rise time and an exponential-like fall of about 250 µsec.  A burst of 3 such pulses repeating every 5 msec is applied every 30 msec in packets of three and the whole packet train is repeated every 300 msec.  The polarity of the pulses is reversed every 10 seconds. The coils in the QRS device are large enough to allow maximum induced electric fields in the mV/cm range within a large tissue volume, comparable to typical bone growth stimulators. The signal is very broadband because both pulses and pulse bursts are repetitive.  The primary stimulus of the QRS signal is most likely to be an induced electric field since it is well within range to be detectable by cell and/or tissue targets above background thermal and other voltage noise. Patients in both groups were treated identically, with an inactive QRS device being employed in the sham group. The QRS signal was administered by a health professional in a clinic setting daily for 8 mins twice per day for 6 weeks. Evaluations were at 0,4,6,10 weeks. Outcome measures included Knee Society Score (KSS), pain measures, CRP, P-fibrinogen and an inflammation parameter. RESULTS: KSS improved only in the active group vs baseline, 7.3% vs 3% improvement (P<0.05). Knee function (P<0.01) and walking ability (P<0.05) improved significantly. Pain (28% vs 16%), general condition (6% vs 18%) and well being improved more in the active group (P<0.01). Medication use showed a non-significant trend to decrease in the active group.  At 6 weeks P-fibrinogen showed a 14% decrease, C-reactive protein 35% decrease and blood sedimentation rate 19% decrease. Systolic blood pressure improved significantly (4% decrease vs 6% increase) after 6 wks and remained decreased for a further 4 weeks post QRS exposure. CONCLUSIONS: The results from this study suggest that broadband ELF very low strength pulsing magnetic fields can have a physiologically significant impact on osteoarthritis of the knee. Compared to the devices discussed above, the complex QRS signal (like some bone healing devices) may couple more efficiently to the cell/tissue target than simpler sinusoidal waves. Clearly these results need to be extended, but they are promising enough to suggest that non-invasive weak pulsing electromagnetic fields may well be of importance in the treatment of osteoarthritis.