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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: Completed Phase 3 study, sponsored by Weill Medical College of Cornell University.
NCT00277797 is a Phase 3 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00277797 record still lists
NCT00277797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00277797's enrollment target sits among peer trials
50 1844th of 2000 higher than 141 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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