Status:
COMPLETED
Non-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
BioWave Corporation
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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 un...
Detailed Description
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 e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00277797
Start Date
February 1 2001
End Date
October 1 2008
Last Update
June 17 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Medical College of Cornell University
New York, New York, United States, 10065