Comparison of Electrotherapies for Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Electronic Wave Form Inc
Information provided by (Responsible Party):
Matt Hughes, MD, MPH, University of Utah
ClinicalTrials.gov Identifier:
NCT01658735
First received: July 30, 2012
Last updated: May 21, 2014
Last verified: May 2014

July 30, 2012
May 21, 2014
July 2012
October 2013   (final data collection date for primary outcome measure)
  • Change from baseline in Oswestry Disability Index at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change from baseline in Oswestry Disability Index at 4 weeks [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Oswestry Disability Index at 8 weeks [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in Oswestry Disability Index at 12 weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01658735 on ClinicalTrials.gov Archive Site
  • Change from baseline in VAS Pain Score at 1 week [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • Change from baseline in VAS Pain Score at 4 weeks [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in VAS Pain Score at 8 weeks [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in VAS Pain Score at 12 weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Electrotherapies for Chronic Low Back Pain
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-specific Chronic Low Back Pain
  • Device: 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.
    Other Name: H-Wave is the proprietary name of the device. There is only one model currently.
  • Device: 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.
    Other Name: Chattanooga Intellect TENS Device
  • Device: 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.
  • Active Comparator: H-Wave Device
    H-Wave Device with Usual Care
    Intervention: Device: H-Wave
  • Active Comparator: TENS
    Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
    Intervention: Device: Transcutaneous Electrical Nerve Stimulation (TENS)
  • Sham Comparator: Sham Electrotherapy
    Sham Device plus Usual Care.
    Intervention: Device: Sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01658735
IRB_00052918, IRB_00052918
Yes
Matt Hughes, MD, MPH, University of Utah
University of Utah
Electronic Wave Form Inc
Principal Investigator: Matthew A Hughes DFPM-ADMINISTRATION
University of Utah
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP