Non-specific Chronic Low Back Pain
Conditions
Keywords
Chronic low back pain, Electrotherapy, H-Wave, H wave, TENS, Trial
Brief 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. 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.
Interventions
DEVICEH-Wave
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.
DEVICETranscutaneous Electrical Nerve Stimulation (TENS)
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.
DEVICESham
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.
Sponsors
Electronic Waveform Lab, Inc.
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Oswestry Disability Index at 12 Weeks | 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. |
| Change From Baseline in Oswestry Disability Index at 1 Week | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in VAS Pain Score at 1 Week | Week 1 | 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. |
| Change From Baseline in VAS Pain Score at 4 Weeks | Week 4 | 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. |
| Change From Baseline in VAS Pain Score at 8 Weeks | Week 8 | 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. |
| Change From Baseline in VAS Pain Score at 12 Weeks | Week 12 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| H-Wave Device H-Wave Device with Usual Care
H-Wave: 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. | 39 |
| TENS Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): 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. | 36 |
| Sham Electrotherapy Sham Device plus Usual Care.
Sham: 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. | 38 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 5 | 3 |
Baseline characteristics
| Characteristic | H-Wave Device | TENS | Sham Electrotherapy | Total |
|---|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 12.1 | 48.5 years STANDARD_DEVIATION 11.5 | 45.5 years STANDARD_DEVIATION 12 | 47.6 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 36 Participants | 36 Participants | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of participants currently working at enrollment No | 10 participants | 8 participants | 7 participants | 25 participants |
| Number of participants currently working at enrollment Yes | 29 participants | 28 participants | 31 participants | 88 participants |
| Number of participants that have ever smoked greater than 100 cigarettes - lifetime No | 30 participants | 32 participants | 29 participants | 91 participants |
| Number of participants that have ever smoked greater than 100 cigarettes - lifetime Yes | 9 participants | 4 participants | 9 participants | 22 participants |
| Number of participants who have been to a chronic pain clinic for their current LBP No | 34 participants | 31 participants | 37 participants | 102 participants |
| Number of participants who have been to a chronic pain clinic for their current LBP Yes | 5 participants | 5 participants | 1 participants | 11 participants |
| Number of participants who have ever seen a Chiropractor for LBP No | 16 participants | 13 participants | 13 participants | 42 participants |
| Number of participants who have ever seen a Chiropractor for LBP Yes | 23 participants | 23 participants | 25 participants | 71 participants |
| Number of participants who have ever seen a physical therapist for LBP NO | 22 participants | 18 participants | 16 participants | 56 participants |
| Number of participants who have ever seen a physical therapist for LBP Yes | 17 participants | 18 participants | 22 participants | 57 participants |
| Number of participants who have seen a Physician for their current LBP No | 16 participants | 8 participants | 11 participants | 35 participants |
| Number of participants who have seen a Physician for their current LBP Yes | 23 participants | 28 participants | 27 participants | 78 participants |
| Participants of participants who have ever had a MRI for their current LBP No | 22 participants | 19 participants | 21 participants | 62 participants |
| Participants of participants who have ever had a MRI for their current LBP Yes | 17 participants | 17 participants | 17 participants | 51 participants |
| Sex: Female, Male Female | 16 Participants | 9 Participants | 16 Participants | 41 Participants |
| Sex: Female, Male Male | 23 Participants | 27 Participants | 22 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 39 | 2 / 36 | 1 / 38 |
| serious Total, serious adverse events | 0 / 39 | 0 / 36 | 0 / 38 |
Outcome results
Primary
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H-Wave Device | Change From Baseline in Oswestry Disability Index at 12 Weeks | -5.388 units on a scale |
| TENS | Change From Baseline in Oswestry Disability Index at 12 Weeks | -6.907 units on a scale |
| Sham Electrotherapy | Change From Baseline in Oswestry Disability Index at 12 Weeks | -5.612 units on a scale |
Primary
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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H-Wave Device | Change From Baseline in Oswestry Disability Index at 1 Week | -2.507 units on a scale |
| TENS | Change From Baseline in Oswestry Disability Index at 1 Week | -4.725 units on a scale |
| Sham Electrotherapy | Change From Baseline in Oswestry Disability Index at 1 Week | -4.752 units on a scale |
Primary
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H-Wave Device | Change From Baseline in Oswestry Disability Index at 4 Weeks | -5.002 units on a scale |
| TENS | Change From Baseline in Oswestry Disability Index at 4 Weeks | -5.135 units on a scale |
| Sham Electrotherapy | Change From Baseline in Oswestry Disability Index at 4 Weeks | -4.581 units on a scale |
Primary
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H-Wave Device | Change From Baseline in Oswestry Disability Index at 8 Weeks | -5.299 units on a scale |
| TENS | Change From Baseline in Oswestry Disability Index at 8 Weeks | -5.135 units on a scale |
| Sham Electrotherapy | Change From Baseline in Oswestry Disability Index at 8 Weeks | -4.679 units on a scale |
Secondary
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H-Wave Device | Change From Baseline in VAS Pain Score at 12 Weeks | -2.624 units on a scale |
| TENS | Change From Baseline in VAS Pain Score at 12 Weeks | -1.922 units on a scale |
| Sham Electrotherapy | Change From Baseline in VAS Pain Score at 12 Weeks | -2.467 units on a scale |
Secondary
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.
Time frame: Week 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H-Wave Device | Change From Baseline in VAS Pain Score at 1 Week | -1.458 units on a scale |
| TENS | Change From Baseline in VAS Pain Score at 1 Week | -1.929 units on a scale |
| Sham Electrotherapy | Change From Baseline in VAS Pain Score at 1 Week | -2.042 units on a scale |
Secondary
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H-Wave Device | Change From Baseline in VAS Pain Score at 4 Weeks | -2.017 units on a scale |
| TENS | Change From Baseline in VAS Pain Score at 4 Weeks | -1.691 units on a scale |
| Sham Electrotherapy | Change From Baseline in VAS Pain Score at 4 Weeks | -1.843 units on a scale |
Secondary
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H-Wave Device | Change From Baseline in VAS Pain Score at 8 Weeks | -2.510 units on a scale |
| TENS | Change From Baseline in VAS Pain Score at 8 Weeks | -2.147 units on a scale |
| Sham Electrotherapy | Change From Baseline in VAS Pain Score at 8 Weeks | -2.467 units on a scale |