Comparison of Electrotherapies for Chronic Low Back Pain

CompletedNot applicableNCT01658735

View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title: Electrical Stimulation for Chronic Non-specific Low Back Pain in a Working-Age Population: A 12-Week Double Blinded Randomized Controlled Trial
Conditions: Non-specific Chronic Low Back Pain
Interventions: Device: H-Wave
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Device: Sham
Sponsor: University of Utah
Collaborators: Electronic Waveform Lab, Inc.
Start date: 2012-07
Primary completion: 2013-10
Sex: All
Age range: from 18 Years to 65 Years
Results posted: Yes, on ClinicalTrials.gov
Total sites listed: 0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01658735