Addressing Pain and Disability From Low Back Pain With an External Multimodal Neuromodulation Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MMJ Labs LLC
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change in current pain intensity from initial to final
研究概览
简要总结
Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control
详细描述
160 patients with moderate to severe acute or exacerbations of chronic low back pain presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate; or an 8 channel prescription TENS unit. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.
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)
盲法说明
Participants will be instructed that non-drug interventions are being evaluated for their impact on opioid use and pain with low back pain, and that they will be self-assessing pain and reporting use of prescribed and over-the-counter medications. Study staff will train them on the device or TENS units via a pre-made video, but investigators and outcomes assessors (statistician) will not be informed of the hypothesis-driving condition arm. An assessment for blinding will be administered at the end of the data collection for participants, asking whether participants believe they are in treatment or control, and how confident they are.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pacemaker
- •Radicular pain likely reflecting a surgical or mechanical problem
- •BMI greater than 50 (device won't fit, initially thought to be BMI 30 but up to 50 included)
- •Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
- •Diabetic neuropathy rendering a patient unable to determine if the device is too hot
- •New neurologic deficits
- •Skin lesions over the low back area
- •Contraindication to any medication for pain management that would impact analgesic use record
- •Inability to apply DuoTherm or Active Control TENS Device
结局指标
主要结局
Change in current pain intensity from initial to final
时间窗: Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic)
Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
时间窗: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)
Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest) normed on a T-Score where 50 is the average in the United States, 40.7 is "no disability", 55 is mild, 57.7 is moderate, and 65.7 is severe
Change in current pain intensity from initial to final
时间窗: Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic)
Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
时间窗: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)
Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest) normed on a T-Score where 50 is the average in the United States, 40.7 is "no disability", 55 is mild, 57.7 is moderate, and 65.7 is severe
次要结局
- Resolution of disability using PROMIS Pain Interference(Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic))
- Resolution of disability using PROMIS Pain Interference(Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (8a) measures in those with intractable pain as defined and compared with surgical multifidus intervention studies(Initial through 6 month measurements (or 13 week if chronic enrolled as acute))
研究者
Amy Lynn Baxter
Principal Investigator
MMJ Labs LLC