Comparison of Electrotherapies for Chronic Low Back Pain

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Non-specific Chronic Low Back Pain

Treatments: Device: Sham; Device: H-Wave; Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01658735

IRB_00052918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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113 participants in 3 patient groups

H-Wave Device

Active Comparator group

Description:

H-Wave Device with Usual Care

Treatment:

Device: H-Wave

TENS

Active Comparator group

Description:

Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Sham Electrotherapy

Sham Comparator group

Description:

Sham Device plus Usual Care.

Treatment:

Device: Sham