Comparison of Electrotherapies for Chronic Low Back Pain
Condition: Non-specific Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): H-Wave; Transcutaneous Electrical Nerve Stimulation (TENS); Sham
Intervention type(s): Device; Device; Device
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): H-Wave is the proprietary name of the device. There is only one model currently.; Chattanooga Intellect TENS Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic low back pain; Electrotherapy; H-Wave; H wave; TENS; Trial