Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing Pain Relief in Acute and Chronic Low Back Pain
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
- Opioid initiation in the opioid-naive
研究概览
简要总结
Evaluate the difference in opioid use, pain intensity and pain interference in patients with moderate to severe low back pain using DuoTherm multimodal harmonic mechanical stimulation (M-Stim) unit compared to Transcutaneous Electrical Nerve Stimulation (TENS)
详细描述
160 patients with acute or exacerbations of chronic low back pain (LBP) presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: an M-Stim pain relief belt device incorporating 8 patterns of vibration motors (and optional heat, cold, and pressure) delivered through a sculpted metal plate; or a 4-lead TENS unit with 8 channels of stimulation and adjustable intensity. Patients will be blinded to the hypothesis-driving intervention. They will be prompted daily by a Qualtrics text link to a secure data recording site collecting analgesic use and treatments, including opioid brand, dose, pill number, and source, and pain data, then weekly for 3 months (acute pain) or 6 months (chronic).
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
Participants were blinded to which device powered the study hypothesis, and blinded to their assigned intervention until after documenting initial NRS pain intensity. The protocol statistician and study coordinator knew device assignments and had access to data, but did not conduct analysis. The PI and treating chiropractor were blinded to allocation and all data during enrollment, with the PI accessing data only after study completion. The analyzing statisticians were blinded to device assignment until completion of analysis. Success of participant blinding was tested with prompts, "select if you received... control or treatment" and "How confident are you?"
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
- •Moderate-to-severe low back pain with numeric rating scale >=4/10
- •Capacity to understand informed consent
- •Willingness to communicate prescriptions, pill number, dose, and source of opioids used
排除标准
- •Opioid prescription in the past month for acute LBP (new pain <3 months)
- •Radicular pain
- •BMI greater than 50 (device won't fit)
- •Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
- •Diabetic neuropathy
- •New neurologic deficits
- •Skin lesions over the low back area
- •Contraindication to any medication for pain management
- •Inability to apply DuoTherm or TENS device
- •Pacemaker
结局指标
主要结局
Opioid initiation in the opioid-naive
时间窗: All opioid diaries for 3 months
New opioid prescriptions for subjects without history of opioids for LBP
Opioid use in prior users
时间窗: 28 days (duration of daily recording)
Change in milligram morphine equivalents (MME) reported daily
次要结局
- Opioid Use Risk Factors in the Opioid-Naive(All opioid diaries for 3 months)
- Opioid Use Risk Factors in the Opioid-Naive(All opioid diaries for 3 months)
- Opioid use in those with more severe pain(All opioid diaries for 6 months)
- Opioid prescribing compared to a contemporaneous national LPB prescribing of 25%(All opioid diaries for 6 months)