Comparison of Electrotherapies for Chronic Low Back Pain

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.

• H-Wave (Device), also known as 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 known as 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.
• Sham (Device): 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.

Primary outcomes

• 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.
• 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.

Secondary outcomes

• 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.

Sex: All, ages: 18 Years to 65 Years

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.

Participant flow

Outcome results

• Change From Baseline in Oswestry Disability Index at 1 Week (Primary), Mean, units on a scale: H-Wave Device -2.507 (-4.56 to -0.45); TENS -4.725 (-6.94 to -2.51); Sham Electrotherapy -4.752 (-6.94 to -2.56)
• Change From Baseline in Oswestry Disability Index at 4 Weeks (Primary), Mean, units on a scale: H-Wave Device -5.002 (-7.51 to -2.5); TENS -5.135 (-7.88 to -2.39); Sham Electrotherapy -4.581 (-7.25 to -1.91)
• Change From Baseline in Oswestry Disability Index at 8 Weeks (Primary), Mean, units on a scale: H-Wave Device -5.299 (-8.19 to -2.41); TENS -5.135 (-7.88 to -2.39); Sham Electrotherapy -4.679 (-7.41 to -1.89)
• Change From Baseline in Oswestry Disability Index at 12 Weeks (Primary), Mean, units on a scale: H-Wave Device -5.388 (-8.47 to -2.3); TENS -6.907 (-10.32 to -3.49); Sham Electrotherapy -5.612 (-8.82 to -2.4)
• Change From Baseline in VAS Pain Score at 1 Week (Secondary), Mean, units on a scale: H-Wave Device -1.458 (-2.21 to -0.93); TENS -1.929 (-2.75 to -1.11); Sham Electrotherapy -2.042 (-2.84 to -1.25)
• Change From Baseline in VAS Pain Score at 4 Weeks (Secondary), Mean, units on a scale: H-Wave Device -2.017 (-2.9 to -1.13); TENS -1.691 (-2.66 to -0.72); Sham Electrotherapy -1.843 (-2.79 to -0.9)
• Change From Baseline in VAS Pain Score at 8 Weeks (Secondary), Mean, units on a scale: H-Wave Device -2.510 (-3.53 to -1.49); TENS -2.147 (-3.28 to -1.02); Sham Electrotherapy -2.467 (-3.41 to -1.52)
• Change From Baseline in VAS Pain Score at 12 Weeks (Secondary), Mean, units on a scale: H-Wave Device -2.624 (-3.53 to -1.72); TENS -1.922 (-2.91 to -0.93); Sham Electrotherapy -2.467 (-3.41 to -1.52)

Adverse events

Time frame: Within 12 weeks the participant was enrolled

Other adverse events by term

Limitations and caveats: Participant enrollment was based on chronic pain VAS score of >= 5.0 (0-10 scale). High baseline VAS scores did not translate to a priori hypothesized high ODI scores, resulting in study being underpowered to detect differences in primary outcomes.

• 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. PMID 23537462

• Matthew A Hughes, Principal investigator, DFPM-ADMINISTRATION