Back to resultsNon-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Biowave Targeted Non-Invasive Electronic Pain Control Device
TENS (Transcutaneous Electrical Nerve Stimulation) device
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Low Back Pain
Eligibility 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 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 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.
Sites / Locations
- Weill Medical College of Cornell University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Biowave first
TENS first
Arm Description
First Treatment: Biowave; Second Treatment: TENS
First Treatment: TENS; Second Treatment: Biowave
Outcomes
Primary Outcome Measures
Comparison of mean pain scores ("deep" pain and "superficial" or "surface" pain visual analog scales [VAS])
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00277797
First Posted
January 12, 2006
Last Updated
June 13, 2013
Sponsor
Weill Medical College of Cornell University
Collaborators
BioWave Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00277797
Brief Title
Non-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain
Official Title
A Randomized, 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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
BioWave Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biowave first
Arm Type
Active Comparator
Arm Description
First Treatment: Biowave; Second Treatment: TENS
Arm Title
TENS first
Arm Type
Active Comparator
Arm Description
First Treatment: TENS; Second Treatment: Biowave
Intervention Type
Device
Intervention Name(s)
Biowave Targeted Non-Invasive Electronic Pain Control Device
Other Intervention Name(s)
Biowave
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TENS (Transcutaneous Electrical Nerve Stimulation) device
Other Intervention Name(s)
Empi's (St. Paul, MN) Epix XL
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Range of motion test
Time Frame
before and after treatment
Title
Patient global impressions of change (PGIC)
Time Frame
at end of treatment, and one day and one week after treatment
Title
Mean pain scores to assess duration of analgesia.
Time Frame
at 4, 6, 12, 24 and 48 hours following discontinuation of treatment
Title
Nature, frequency, and intensity of adverse events.
Time Frame
continuous
Title
Physical examination and assessment of vital signs.
Time Frame
baseline, pre-treatment, and post-treatment
Title
follow-up phone interviews.
Time Frame
one day and one week post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh C. Hemmings Jr., MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.biowave.com
Description
Sponsor Website
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Non-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain
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