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.
Official Title
A Randomised, Single-Blinded, Comparative Crossover Trial of the Safety and Efficacy of a Non-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain.
Conditions
- Chronic Low Back Pain
Study Type
Interventional
Study Design
Treatment, Randomised, Single Blind (Subject), Active Control, Crossover Assignment, Safety/Efficacy Study
Further Details
-
Comparison of mean pain scores ("deep" pain and "superficial" or "surface" pain visual analog scales [VAS])
-
Range of motion test
-
Patient global impressions of change (PGIC)
-
Mean pain scores to assess duration of analgesia.
-
Nature, frequency, and intensity of adverse events.
-
Physical examination and assessment of vital signs.
-
follow-up phone interviews.
Study Start
February 2001
Eligibility & Criteria
Official Title
A Randomised, Single-Blinded, Comparative Crossover Trial of the Safety and Efficacy of a Non-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain.
Conditions
- Chronic Low Back Pain
Study Type
Interventional
Study Design
Treatment, Randomised, Single Blind (Subject), Active Control, Crossover Assignment, Safety/Efficacy Study
Further Details
-
Comparison of mean pain scores ("deep" pain and "superficial" or "surface" pain visual analog scales [VAS])
-
Range of motion test
-
Patient global impressions of change (PGIC)
-
Mean pain scores to assess duration of analgesia.
-
Nature, frequency, and intensity of adverse events.
-
Physical examination and assessment of vital signs.
-
follow-up phone interviews.
Study Start
February 2001
Eligibility & Criteria
Eligibility
- Ages Eligible for Study: 18 Years to 60 Years
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
- 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 randomised). 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.
Exclusion Criteria:
- 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.
Total Enrolment
50
Contact Details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277797
Telephone: +1-746-1067
Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10065
Sponsors and Collaborators
- Weill Medical College of Cornell University
- Biowave Corporation
Investigators
Principal Investigator: Hugh C. Hemmings Jr., MD, PhD Weill Medical College of Cornell University
Total Enrolment
50
Contact Details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277797
Telephone: +1-746-1067
Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10065
Sponsors and Collaborators
- Weill Medical College of Cornell University
- Biowave Corporation
Investigators
Principal Investigator: Hugh C. Hemmings Jr., MD, PhD Weill Medical College of Cornell University
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