Chronic Low Back PainPhase 3NCT00277797
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 testing TENS (Transcutaneous Electrical Nerve Stimulation) device in people with Chronic Low Back Pain, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- TENS (Transcutaneous Electrical Nerve Stimulation) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Oct 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10065
About this study
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.
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).
Read more
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Biowave Targeted Non-Invasive Electronic Pain Control Device, TENS (Transcutaneous Electrical Nerve Stimulation) device
- Keywords
- Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biowave Targeted Non-Invasive Electronic Pain Control DeviceDevice
Also called Biowave
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.
TENS (Transcutaneous Electrical Nerve Stimulation) deviceDevice
Also called Empi's (St. Paul, MN) Epix XL
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.
| Study group | Role | What they receive |
|---|---|---|
| Biowave first | Active comparator | First Treatment: Biowave; Second Treatment: TENS Receives: Device: Biowave Targeted Non-Invasive Electronic Pain Control Device; Device: TENS (Transcutaneous Electrical Nerve Stimulation) device |
| TENS first | Active comparator | First Treatment: TENS; Second Treatment: Biowave Receives: Device: Biowave Targeted Non-Invasive Electronic Pain Control Device; Device: TENS (Transcutaneous Electrical Nerve Stimulation) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean pain scores ("deep" pain and "superficial" or "surface" pain visual analog scales [VAS])
Measured: determined at baseline, 20 minutes after optimization of signal amplitude, and at 30 and minutes 60 following discontinuation of treatm
Secondary outcomes (6)
Range of motion test
Measured: before and after treatment
Patient global impressions of change (PGIC)
Measured: at end of treatment, and one day and one week after treatment
Mean pain scores to assess duration of analgesia.
Measured: at 4, 6, 12, 24 and 48 hours following discontinuation of treatment
Nature, frequency, and intensity of adverse events.
Measured: continuous
Physical examination and assessment of vital signs.
Measured: baseline, pre-treatment, and post-treatment
follow-up phone interviews.
Measured: one day and one week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startFeb 2001
- Primary completionMar 2006
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- BioWave Corporation
- Responsible party
- Sponsor
- Investigators
- Hugh C. Hemmings Jr., MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277797
- Sponsor's protocol ID
- 0102004819
- Status last verified
- Jun 2013
- First submitted
- 12 Jan 2006
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00277797
- Acronym / sponsor ID
- 0102004819
- Conditions
- Chronic Low Back Pain
- Keywords
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- BioWave Corporation
- Study start
- Feb 2001
- Primary completion
- Mar 2006 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biowave first | Active comparator | Device: Biowave Targeted Non-Invasive Electronic Pain Control Device, Device: TENS (Transcutaneous Electrical Nerve Stimulation) deviceFirst Treatment: Biowave; Second Treatment: TENS |
| TENS first | Active comparator | Device: Biowave Targeted Non-Invasive Electronic Pain Control Device, Device: TENS (Transcutaneous Electrical Nerve Stimulation) deviceFirst Treatment: TENS; Second Treatment: Biowave |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- Epilepsy
- Pregnancy
- Pacemaker
- History of cardiac arrhythmias
- Implantable devices (AICD, pump, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biowave Targeted Non-Invasive Electronic Pain Control DeviceAlso: BiowaveThis 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. | Device | Biowave first, TENS first |
| TENS (Transcutaneous Electrical Nerve Stimulation) deviceAlso: Empi's (St. Paul, MN) Epix XLThis 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. | Device | Biowave first, TENS first |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- Sponsor WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh C. Hemmings Jr., MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TENS (Transcutaneous Electrical Nerve Stimulation) device in people with Chronic Low Back Pain, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.