A Phase 3 interventional study of Biowave Targeted Non-Invasive Electronic Pain Control Device and TENS (Transcutaneous Electrical Nerve Stimulation) device in Chronic Low Back Pain, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-06-17.
Sponsored by Weill Medical College of Cornell University · Phase 3, Interventional, and Treatment
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.
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 exact mechanism is not completely understood, it is proposed that its effectiveness is based on the gate control theory. Biowave has developed new patentable technology \& a related device in the field of electromedicine. The device delivers a precise electrical signal to a specific volume of tissue in the body, which blocks the transmission of pain impulses.
Treatment Plan-Treatment will be initiated with device indicated by the order to which the pt. was randomized. Pts. will be connected to one of two devices hidden from view by application of two small round two-inch diameter electrodes to the lower back.
Baseline-A complete medical history \& a physical examination will be performed. The pt. will complete a BPI questionnaire \& be randomized to one of two treatment orders: 1) Biowave device followed by TENS device or 2) TENS device followed by Biowave Device. 2 treatment sessions will be separated by at least 72 hours.
Treatment-Prior to each treatment session, pt. will complete initial VAS evaluations. Pt.'s ROM will be assessed \& vital signs will be obtained. Pts. will complete VAS \& categorical pain assessments at end of the 20 minute treatment period.
Post-treatment-Pts. will repeat ROM test after device has been turned off \& electrodes removed. VAS pain evaluations will be completed by the pt. at 30 \& 60 minutes, vital signs \& patient global impression of change will be obtained at 60 minutes following discontinuation of therapy. Pts. will be given VAS \& categorical pain assessments to be completed at 4, 6, 12, 24 and 48 hours \& 1 week after treatment (to be returned by mail/fax) to assess possible long-term analgesic effects.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
First Treatment: Biowave; Second Treatment: TENS
Device: Biowave Targeted Non-Invasive Electronic Pain Control Device · Device: TENS (Transcutaneous Electrical Nerve Stimulation) device
First Treatment: TENS; Second Treatment: Biowave
Device: Biowave Targeted Non-Invasive Electronic Pain Control Device · Device: TENS (Transcutaneous Electrical Nerve Stimulation) device
This device is a non-invasive non-pharmacologic treatment for pain. It sends a premixed modulated envelope of two high frequency electronic wave forms ("Feed Signals") between two electrodes.
Also known as: Biowave
This device features a bisourced, biphasic waveform. The combined constant voltage, constant-current waveform provides a strong stimulus that allows the clinician to prescribe a treatment program.
Also known as: Empi's (St. Paul, MN) Epix XL
Comparison of mean pain scores ("deep" pain and "superficial" or "surface" pain visual analog scales [VAS])
Time frame: determined at baseline, 20 minutes after optimization of signal amplitude, and at 30 and minutes 60 following discontinuation of treatm
Range of motion test
Time frame: before and after treatment
Patient global impressions of change (PGIC)
Time frame: at end of treatment, and one day and one week after treatment
Mean pain scores to assess duration of analgesia.
Time frame: at 4, 6, 12, 24 and 48 hours following discontinuation of treatment
Nature, frequency, and intensity of adverse events.
Time frame: continuous
Physical examination and assessment of vital signs.
Time frame: baseline, pre-treatment, and post-treatment
follow-up phone interviews.
Time frame: one day and one week post-treatment
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University