Clinical trial NCT01658735: Comparison of Electrotherapies for Chronic Low Back Pain
Official title: Electrical Stimulation for Chronic Non-specific Low Back Pain in a Working-Age Population: A 12-Week Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Chronic Low Back Pain
Keywords: Chronic low back pain
Electrotherapy
H-Wave
H wave
TENS
Trial
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Electronic Waveform Lab, Inc.
First posted: 2012-08-07
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Oswestry Disability Index at 1 Week
timeFrame: 1 week
measure: Change From Baseline in Oswestry Disability Index at 4 Weeks
timeFrame: Week 4
measure: Change From Baseline in Oswestry Disability Index at 8 Weeks
timeFrame: Week 8
measure: Change From Baseline in Oswestry Disability Index at 12 Weeks
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in VAS Pain Score at 1 Week
timeFrame: Week 1
measure: Change From Baseline in VAS Pain Score at 4 Weeks
timeFrame: Week 4
measure: Change From Baseline in VAS Pain Score at 8 Weeks
timeFrame: Week 8
measure: Change From Baseline in VAS Pain Score at 12 Weeks
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: DFPM-ADMINISTRATION
name: Matthew A Hughes
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.