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Comparison of Electrotherapies for Chronic Low Back Pain

This study is ongoing, but not recruiting participants.
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: August 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Non-specific Chronic Low Back Pain
 Device: H-Wave
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Device: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrical Stimulation for Chronic Non-specific Low Back Pain in a Working-Age Population: A 12-Week Double Blinded Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 114
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: H-Wave Device
H-Wave Device with Usual Care
 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.
Active Comparator: TENS
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
 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
Sham Comparator: Sham Electrotherapy
Sham Device plus Usual Care.
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658735

Sponsors and Collaborators
University of Utah
Electronic Wave Form Inc
Investigators
Principal Investigator: Matthew A Hughes DFPM-ADMINISTRATION
  More Information

No publications provided

Responsible Party: Matt Hughes, MD, MPH, Assistant Professor (clinical), University of Utah
ClinicalTrials.gov Identifier: NCT01658735     History of Changes
Other Study ID Numbers: IRB_00052918, IRB_00052918
Study First Received: July 30, 2012
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Chronic low back pain
Electrotherapy
H-Wave
 H wave
TENS
Trial

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013