Non-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain

Background-Low back pain is a common, costly \& often chronic condition, estimated to affect 85% of people in their lifetime. A form of electronic pain control currently in use is TENS. Although the exact mechanism is not completely understood, it is proposed that its effectiveness is based on the gate control theory. Biowave has developed new patentable technology \& a related device in the field of electromedicine. The device delivers a precise electrical signal to a specific volume of tissue in the body, which blocks the transmission of pain impulses. Treatment Plan-Treatment will be initiated with device indicated by the order to which the pt. was randomized. Pts. will be connected to one of two devices hidden from view by application of two small round two-inch diameter electrodes to the lower back. Baseline-A complete medical history \& a physical examination will be performed. The pt. will complete a BPI questionnaire \& be randomized to one of two treatment orders: 1) Biowave device followed by TENS device or 2) TENS device followed by Biowave Device. 2 treatment sessions will be separated by at least 72 hours. Treatment-Prior to each treatment session, pt. will complete initial VAS evaluations. Pt.'s ROM will be assessed \& vital signs will be obtained. Pts. will complete VAS \& categorical pain assessments at end of the 20 minute treatment period. Post-treatment-Pts. will repeat ROM test after device has been turned off \& electrodes removed. VAS pain evaluations will be completed by the pt. at 30 \& 60 minutes, vital signs \& patient global impression of change will be obtained at 60 minutes following discontinuation of therapy. Pts. will be given VAS \& categorical pain assessments to be completed at 4, 6, 12, 24 and 48 hours \& 1 week after treatment (to be returned by mail/fax) to assess possible long-term analgesic effects.