Comparison of Electrotherapies for Chronic Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Electrical Stimulation for Chronic Non-specific Low Back Pain in a Working-Age Population: A 12-Week Double Blinded Randomized Controlled Trial

Conditions
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Non-specific Chronic Low Back Pain

Intervention / Treatment
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* Device: H-Wave
* Device: Transcutaneous Electrical Nerve Stimulation (TENS)
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: H-Wave Device<br>H-Wave Device with Usual Care | Device: H-Wave<br>* 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.<br>* Other names: H-Wave is the proprietary name of the device. There is only one model currently.;|
| Active Comparator: TENS<br>Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care | Device: Transcutaneous Electrical Nerve Stimulation (TENS)<br>* 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.<br>* Other names: Chattanooga Intellect TENS Device;|
| Sham Comparator: Sham Electrotherapy<br>Sham Device plus Usual Care. | Device: Sham<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain, Electrotherapy, H-Wave, H wave, TENS, Trial