Electrical Stimulation for Chronic Non-specific Low Back Pain in a Working-Age Population: A 12-Week Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 主要终点
- Change From Baseline in Oswestry Disability Index at 1 Week
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change From Baseline in Oswestry Disability Index at 1 Week
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change From Baseline in VAS Pain Score at 1 Week(Week 1)
- Change From Baseline in VAS Pain Score at 4 Weeks(Week 4)
- Change From Baseline in VAS Pain Score at 8 Weeks(Week 8)
- Change From Baseline in VAS Pain Score at 12 Weeks(Week 12)
研究者
Matt Hughes, MD, MPH
Assistant Professor (clinical)
University of Utah