NCT04109703已完成不适用
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain Rating
研究概览
简要总结
This study is a double blinded randomized active placebo controlled trial in subjects with chronic low back pain. The trial compares pain relief by a device that delivered high level pulsed heat (45 °C) to pain relief delivered by a steady heat lower temperature device (37 °C). The hypothesis is that the high temperature pulsed heat device will produce significantly better pain relief as compared to the lower level steady heat device. The secondary hypothesis is that pain relief will occur faster in the high pulsed heat device as compared to the control device.
详细描述
- This study will be conducted under Good Clinical Practice (GCP) guidelines and suitable for FDA submission in order to obtain claims such as, "provides temporary pain relief for people with chronic lower back pain."
- The study is designed as a randomized double blinded two arm placebo controlled trial.
- The active arm (N=50) receives two active Series 5 heating units (Soovu Labs Inc.) that pulse heat to 45ºC (113ºF). The active Series 5 placebo arm (N=50) gets two identical appearing units (Soovu Labs Inc.) that produce low level of heat at 37ºC (96.8 ºF). For reference skin temperature is about 33 ºC and room temperature 23 ºC.
- The study hypothesis is that in subjects with chronic low back pain, the active heating device group will show a statistical improvement in pain scores as compared to the active placebo group as measured by the primary outcome measure, the Numeric Pain Scale (NPS).
- Subjects will be told the study is examining the pain relieving effectiveness of two different levels of heat.
- Subjects must have chronic low back pain with a pretreatment level of pain 4 or greater on a 0-10 point scale. By definition chronic low back pain is a condition that has been present for at least 6 months and must be present more days than not over the course of a week.
- No use of pain medications during the four hour trial. However, pain medications including schedule IIIs can be taken up to 30 minutes before the start of the trial. Medications permitted during the trial include medications such as tramadol, codeine, NSIADs, gabapentin and acetaminophen. Non-pain medications for medical indications are permitted at any time. Subjects taking schedule II opioids are excluded from the study. Schedule II opioids include oxycodone, hydromorphone, hydrocodone, fentanyl and methadone.
- Ages 22 through 70 inclusive.
- Exclusion criteria- sciatica if present must be rated significantly less than the non -radiating component of the low back pain, pregnancy, skin lesions such as open skin or sores, scar tissue, skins grafts, old burns over the treatment area or neuropathic sensory loss over the treatment site.
- Pre-treatment assessments include, Numeric Pain Scale, and a pre-study questionnaire (history, treatment preferences, short form Brief Pain Inventory, and short form Magill).
- Each treatment session lasts approximately 30 minutes with pain assessments throughout using NPS (primary outcome measure). Secondary outcome measures include measures of comfort and willingness to endorse their treatment.
- All subjects are followed for a 4 hour post treatment period with intermittent pain assessments (NPS).
- At the end of the post treatment period, subjects complete a post study usability questionnaire and a blinding questionnaire.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded with a control condition using a low level heating (37 degree C) device. The active experimental device used heast that intermittently pulsed to 45 degrees C.
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic low back pain. By definition chronic low back pain is a condition that has been present for at least 6 months on more days than not. If there is a radiating component of the low back pain the radiating component must have a pain rating less than the non-radiating component of the low back pain.
- •Subjects must have pretreatment level of pain 4 or greater.
- •Ages 22 through 70 inclusive
- •Non pain medications are permitted as needed for conditions such as hypertension, diabetes, heart disease etc.
- •Medications such as tramadol, codeine, NSIADs, gabapentin and acetaminophen are not permitted during the trial but may be included under the discretion of the study physician.
- •Subjects must have a reliable method for clinic contact and follow-up.
排除标准
- •Sciatica or radicular pain without non-radiating low back pain, cancer, radicular pain greater than the non-radiating component of low back pain, pregnancy, skin lesions such as open skin or sores, scar tissue, skins grafts, old burns over the treatment area.
- •Medications including oxycodone, hydromorphone, hydrocodone, fentanyl and methadone are excluded from the trial but may be included under the discretion of the study physician. Such decisions will be documented should they occur.
结局指标
主要结局
Pain Rating
时间窗: Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.
Numerical Pain Score (NPS) Range Zero (minimum) through ten (maximum score) thirty minutes after completion of the treatment session.
次要结局
未报告次要终点
研究者
研究点 (2)
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