Non-specific Chronic Low Back PainNCT01658735
Comparison of Electrotherapies for Chronic Low Back Pain
A study testing H-Wave and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Non-specific Chronic Low Back Pain, run by University of Utah.
Trial summary
The intent of this project is to execute a high-quality double-blinded randomized controlled clinical trial that compares the H-Wave® device with a commonly used TENS device with a sub-therapeutic electrocurrent device. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-specific Chronic Low Back Pain
- What is being tested?
- H-Wave and Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Low Back Pain of at least 3 months duration
- ages 18-65
- Current VAS Pain Rating of 5 on 10 point scale
- No pain below the knee
- 75% of pain located in low back or buttock pain rather than lower extremity pain
- Proficient in English
- Able to complete and tolerate treatment for the study period.
Who cannot join
- Prior home use of H-Wave Device or TENS.
- Prior history of spinal fusion or failed spinal surgery syndrome.
- Laminectomy, laminotomy or discectomy within 12 months of enrollment.
- Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency, neuroablation within 6 months of enrollment.
- Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, or other implanted electronic devices.
- Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia, uncontrolled depression or anxiety disorder).
- Patients currently or who become pregnant will be excluded.
About this study
Official title: Electrical Stimulation for Chronic Non-specific Low Back Pain in a Working-Age Population: A 12-Week Double Blinded Randomized Controlled Trial
The intent of this project is to execute a high-quality double-blinded randomized controlled clinical trial that compares the H-Wave® device with a commonly used TENS device with a sub-therapeutic electrocurrent device. This study will provide a definable level of evidence for treatment efficacy, and provide a basis for evidence-based recommendation for or against utilization for these two modalities. The results for H-Wave® device, if positive, could significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for symptomatic relief, and reduce overall disability and health care costs associated with chronic low back pain.
Read the detailed description
H-Wave® Device Stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical participants enrolled (n=38 per arm) of with the same number of visits and investigator contact time.
Eligible participants will be allocated through computerized randomization utilizing a stratified permuted-block randomization employing random block sizes. Allocation is concealed. Participants and assessors will be blinded. Participants will not be told what types of electrotherapy devices are being studied, only that there are different types, and that they may be randomized to receive a sham device.
Patients will be instructed on the use of the device they received to perform daily home therapy. Subjects will be assessed at week 1, 4, 8 and 12 for the primary and secondary outcomes measures. Compliance to treatment will be measured through an electronic meter on each of the devices, as well as by patient diary. Patients will be allowed to receive usual care from their own health care provider, with the exception of invasive procedures or surgery. Results will be analyzed by intention to treat methods.
- Conditions
- Non-specific Chronic Low Back Pain
- Being tested
- H-Wave, Transcutaneous Electrical Nerve Stimulation (TENS), Sham
- Keywords
- Chronic low back pain, Electrotherapy, H-Wave, H wave, TENS, Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-WaveDevice
Also called H-Wave is the proprietary name of the device. There is only one model currently.
Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called Chattanooga Intellect TENS Device
Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
ShamDevice
The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
| Study group | Role | What they receive |
|---|---|---|
| H-Wave Device | Active comparator | H-Wave Device with Usual Care Receives: Device: H-Wave |
| TENS | Active comparator | Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Sham Electrotherapy | Sham comparator | Sham Device plus Usual Care. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Oswestry Disability Index at 1 Week
Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure.
The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Measured: 1 week
Change From Baseline in Oswestry Disability Index at 4 Weeks
Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure.
The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Measured: Week 4
Change From Baseline in Oswestry Disability Index at 8 Weeks
Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure.
The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Measured: Week 8
Change From Baseline in Oswestry Disability Index at 12 Weeks
Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure.
The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Measured: Week 12
Secondary outcomes (4)
Change From Baseline in VAS Pain Score at 1 Week
Measure of the change in visual analogue scale (VAS) after one week of treatment compared with baseline VAS measure.
The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Measured: Week 1
Change From Baseline in VAS Pain Score at 4 Weeks
Measure of the change in visual analogue scale (VAS) after four weeks of treatment compared with baseline VAS measure.
The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Measured: Week 4
Change From Baseline in VAS Pain Score at 8 Weeks
Measure of the change in visual analogue scale (VAS) after eight weeks of treatment compared with baseline VAS measure.
The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Measured: Week 8
Change From Baseline in VAS Pain Score at 12 Weeks
Measure of the change in visual analogue scale (VAS) after twelve weeks of treatment compared with baseline VAS measure.
The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-specific Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Electronic Waveform Lab, Inc.
- Responsible party
- Principal investigator, Matt Hughes, MD, MPH, University of Utah
- Investigators
- Matthew A Hughes, Principal investigator, DFPM-ADMINISTRATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658735
- Sponsor's protocol ID
- IRB_00052918
- Other IDs
- IRB_00052918
- Status last verified
- Feb 2015
- First submitted
- 30 Jul 2012
- Last updated
- 9 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Thiese MS, Hughes M, Biggs J. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial. BMC Musculoskelet Disord. 2013 Mar 28;14:117. doi: 10.1186/1471-2474-14-117.
PubMed 23537462
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation for Chronic Non-specific Low Back Pain in a Working-Age Population: A 12-Week Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01658735
- Acronym / sponsor ID
- IRB_00052918
- Conditions
- Non-specific Chronic Low Back Pain
- Keywords
- Chronic low back pain, Electrotherapy, H-Wave, H wave, TENS, Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Electronic Waveform Lab, Inc.
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Posted 9 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intent of this project is to execute a high-quality double-blinded randomized controlled clinical trial that compares the H-Wave® device with a commonly used TENS device with a sub-therapeutic electrocurrent device. This study will provide a definable level of evidence for treatment efficacy, and provide a basis for evidence-based recommendation for or against utilization for these two modalities. The results for H-Wave® device, if positive, could significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for symptomatic relief, and reduce overall disability and health care costs associated with chronic low back pain.
Detailed description
H-Wave® Device Stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical participants enrolled (n=38 per arm) of with the same number of visits and investigator contact time.
Eligible participants will be allocated through computerized randomization utilizing a stratified permuted-block randomization employing random block sizes. Allocation is concealed. Participants and assessors will be blinded. Participants will not be told what types of electrotherapy devices are being studied, only that there are different types, and that they may be randomized to receive a sham device.
Patients will be instructed on the use of the device they received to perform daily home therapy. Subjects will be assessed at week 1, 4, 8 and 12 for the primary and secondary outcomes measures. Compliance to treatment will be measured through an electronic meter on each of the devices, as well as by patient diary. Patients will be allowed to receive usual care from their own health care provider, with the exception of invasive procedures or surgery. Results will be analyzed by intention to treat methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| H-Wave Device | Active comparator | Device: H-WaveH-Wave Device with Usual Care |
| TENS | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care |
| Sham Electrotherapy | Sham comparator | Device: ShamSham Device plus Usual Care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic Low Back Pain of at least 3 months duration
- ages 18-65
- Current VAS Pain Rating of 5 on 10 point scale
- No pain below the knee
- 75% of pain located in low back or buttock pain rather than lower extremity pain
Key exclusion criteria (7 listed)
- Prior home use of H-Wave Device or TENS.
- Prior history of spinal fusion or failed spinal surgery syndrome.
- Laminectomy, laminotomy or discectomy within 12 months of enrollment.
- Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency, neuroablation within 6 months of enrollment.
- Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, or other implanted electronic devices.
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 |
|---|---|---|
| H-WaveAlso: H-Wave is the proprietary name of the device. There is only one model currently.Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect. | Device | H-Wave Device |
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: Chattanooga Intellect TENS DeviceElectrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding. | Device | TENS |
| ShamThe sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical. | Device | Sham Electrotherapy |
Primary outcome
Change From Baseline in Oswestry Disability Index at 1 Week
Time frame: 1 week
Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Change From Baseline in Oswestry Disability Index at 4 Weeks
Time frame: Week 4
Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Change From Baseline in Oswestry Disability Index at 8 Weeks
Time frame: Week 8
Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Change From Baseline in Oswestry Disability Index at 12 Weeks
Time frame: Week 12
Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
4 secondary outcomes
Change From Baseline in VAS Pain Score at 1 Week
Time frame: Week 1
Change From Baseline in VAS Pain Score at 4 Weeks
Time frame: Week 4
Change From Baseline in VAS Pain Score at 8 Weeks
Time frame: Week 8
Change From Baseline in VAS Pain Score at 12 Weeks
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23537462Thiese MS, Hughes M, Biggs J. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial. BMC Musculoskelet Disord. 2013 Mar 28;14:117. doi: 10.1186/1471-2474-14-117.
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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.
Matthew A Hughes principal investigator
DFPM-ADMINISTRATION
Questions about this trial
What is this clinical trial studying?
A study testing H-Wave and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Non-specific Chronic Low Back Pain, run by University of Utah.
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 7 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Oswestry Disability Index at 1 Week (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01658735, which also lists 1 linked publication.
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 9 Mar 2015.