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NCT00277797 · ClinicalTrials.gov registry record · Phase 3
Non-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain
A Phase 3 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT00277797 is a Phase 3 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 50 participants.
The verdict
NCT00277797, a Phase 3 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study 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 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.
Interventions
- DEVICE Biowave Targeted Non-Invasive Electronic Pain Control Device
- DEVICE TENS (Transcutaneous Electrical Nerve Stimulation) device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2001-02 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00277797
The ClinicalTrials.gov registry entry for NCT00277797 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Biowave Targeted Non-Invasive Electronic Pain Control Device is the first listed.
NCT00277797 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00277797 about?
NCT00277797 is a clinical study titled "Non-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain". 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...
What is the current status of trial NCT00277797?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2001-02. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00277797?
The interventions under investigation include: Biowave Targeted Non-Invasive Electronic Pain Control Device (DEVICE), TENS (Transcutaneous Electrical Nerve Stimulation) device (DEVICE).
Who is sponsoring clinical trial NCT00277797?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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