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

Completed · Phase 3

Conditions studied: Chronic Low Back Pain

In brief

Low back pain is a common condition, which extols a large cost to society from lost wages The Biowave System was developed by Biowave Corporation (Biowave), Norwalk, CT. Two wires emanate from the unit. The feed wire is attached to a large disposable input pad ("Feed Electrode"). The return wire is attached to a smaller pad ("Return Electrode") over the source of the pain (the treatment site). The device sends a premixed modulated envelope of two high frequency electronic wave forms ("Feed Signal") between the two electrodes. The beat frequency of the modulated envelope ("d-Frequency") is equal to the difference in frequency of the two feed signals. The location of beat frequency formation is dependent on the size and location of the two electrodes. With the configuration used in the study, the beat frequency signal is believed to form immediately ventrally to the Return electrode. The size of the volume of tissue affected can be changed and is dependent upon electrode geometry and the amplitude of the Feed Signal. The beat frequency is a low frequency blocking signal which is believed to cause a demodulation in the nerve cells and a reduction of the sodium/potassium ion exchange. As a result, the charge polarity of the nerve cell wall is prevented from changing and is therefore unable to transmit pain impulses. The size of the volume of tissue affected can be changed and is dependent upon electrode geometry and the amplitude of the Feed Signal. The objective of this study is to compare the Biowave System with TENS (a currently available treatment) and to further evaluate its efficacy for the relief of pain in patients with chronic low back pain.

Key facts

Study ID

NCT00277797

Run by

Weill Medical College of Cornell University

People needed

50

Starts

2001-02-01

Expected to finish

2008-10-01

Last updated by the study team

2013-06-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be male or female of any race and between the ages of 18 and 60, inclusive;
• Female patients of childbearing potential may participate if they agree to a urine pregnancy test and the result is negative.
• The primary location of pain must be the lower back area (below 12th thoracic vertebra) without pain radiating to the legs (a subgroup [n=10] with pain radiating to the legs will be studied as well. Treatment will be initiated with the device indicated by the treatment order to which the patient was randomized). The pain must have been present for 3 months or greater prior to entry into the study;
• Patients must have a baseline score of ³40 mm on the VAS pain scale;
• If taking analgesics, patients must agree to maintain a steady regimen for the duration of the study;
• Patients must be able to understand and cooperate with study procedures; and
• Patients must have signed a legally effective written informed consent prior to entering the study.

You may not qualify if…

• Epilepsy
• Pregnancy
• Pacemaker
• History of cardiac arrhythmias
• Implantable devices (AICD, pump, etc.)
• Surgical intervention during the past month for the treatment of low back pain or its underlying etiology
• Other severe pain that may confound assessment or self-evaluation of the chronic low back pain;
• Patients with pending Worker's Compensation claims, pending civil litigation pertinent to the cause of low back pain, currently receiving monetary compensation for the injury resulting in back pain, or currently involved in out-of-court settlements for claims pertinent to their back pain;
• Abuse of illicit drugs or alcohol within the last 6 months;
• Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study;
• Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.

Where it is running

• Weill Medical College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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