Comparison of Electrotherapies for Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Non-specific Chronic Low Back Pain
• Interventions: Device: Sham; Device: H-Wave; Device: Transcutaneous Electrical Nerve Stimulation (TENS)

• Registration Number: NCT01658735
• Lead Sponsor: University of Utah

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-02
• Results First Submitted: 2015-02-09
• Results First Submitted QC: 2015-02-24
• Last Update Submitted: 2015-02-24
• Results First Posted: 2015-03-09
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Electrotherapy	Sham	Sham Device plus Usual Care.
H-Wave Device	H-Wave	H-Wave Device with Usual Care
TENS	Transcutaneous Electrical Nerve Stimulation (TENS)	Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Oswestry Disability Index at 1 Week	1 week	Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure.; The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Change From Baseline in Oswestry Disability Index at 4 Weeks	Week 4	Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure.; The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Change From Baseline in Oswestry Disability Index at 8 Weeks	Week 8	Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure.; The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Change From Baseline in Oswestry Disability Index at 12 Weeks	Week 12	Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure.; The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in VAS Pain Score at 1 Week	Week 1	Measure of the change in visual analogue scale (VAS) after one week of treatment compared with baseline VAS measure.; The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Change From Baseline in VAS Pain Score at 4 Weeks	Week 4	Measure of the change in visual analogue scale (VAS) after four weeks of treatment compared with baseline VAS measure.; The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Change From Baseline in VAS Pain Score at 8 Weeks	Week 8	Measure of the change in visual analogue scale (VAS) after eight weeks of treatment compared with baseline VAS measure.; The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Change From Baseline in VAS Pain Score at 12 Weeks	Week 12	Measure of the change in visual analogue scale (VAS) after twelve weeks of treatment compared with baseline VAS measure.; The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.