Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With Chronic Overlapping Pain Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- The Brief Pain Inventory Interference Scale (BPI)
研究概览
简要总结
This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions.
详细描述
This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions. Participants will attend two quantitative sensory testing visits in order to determine their level of pain sensitivity, one at the beginning of the study and the second at the 3-month Follow-up session. Participants will be asked to test out the Quell device to check for sensation tolerance, and will then be randomized into one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. Participants will be asked to wear the device for at least 3 hours every day and to complete daily assessments, along with a total of three sets of questionnaires: one at the start of the study, the second 6 weeks from the date of consent, and the third 3 months after the date of consent. A member of the research staff will call participants once a week for a brief phone interview throughout the study. Participants will be in this study for 3 months.
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
- Double (Participant, Investigator)
盲法说明
Neither the principal investigator, the co-investigators, the research assistant, or the subjects will know if they are given the high intensity Quell device or the low intensity Quell device.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 21 and older
- •Pain duration > 3 months
- •Diagnosed by physician with multiple chronic pain conditions
- •Have chronic pain related to multiple chronic pain diagnoses (headaches, joint pain, back pain, or any of the other COPCs)
- •Average 4 or greater on pain intensity scale of 0 to 10
- •Pain is not accounted for by any other progressive disease (e.g., cancer, MS)
- •Meets sensory hypersensitivity cutoffs based on QST-assessed evidence
- •Own a smartphone (iPhone or Android device) and can download the pain app (MasterMyPain) and the Quell Relief mobile app onto their device
- •Able to speak and understand English
排除标准
- •Diagnosis of cancer or any other malignant disease
- •Acute osteomyelitis or acute bone disease
- •Present of past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
- •Pregnancy
- •Any clinically unstable systemic illness judged to interfere with treatment
- •A pain condition requiring urgent surgery
- •An active substance use disorder, such as cocaine or IV heroin use that would interfere with study participation
- •Have an implanted cardiac pacemaker, defibrillator, or other implanted device.
- •Reynaud's syndrome
- •Open cuts/sores
结局指标
主要结局
The Brief Pain Inventory Interference Scale (BPI)
时间窗: Between group differences at 3-months
This is a validated measure of combined activity interference on a numerical scale of 0-10, with higher scores representing greater activity interference. We collected ratings on how much pain interfered over the past 24 hours with 1) General activity, 2) Mood, 3) Walking ability, 4) Normal work, 5) Relations with other people, 6) Sleep, and 7) Enjoyment of life on a scale of 0=does not interfere to 10=completely interferes. The table represents combined mean scores between groups. These ratings were collected at 3 months after start of the study.
次要结局
- Pain Catastrophizing Scale (PCS)(Changes from Baseline to 3-month Follow-Up)
- Pain Disability Index (PDI)(Changes from Baseline to 3-month Follow-Up)
- Hospital Anxiety and Depression Scale (HADS)(Changes from Baseline to 3-month Follow-Up)
- Pain Detect Neuropathic Pain Questionnaire (painDETECT)(Changes from Baseline to 3-month Follow-Up)
- Symptom Impact Questionnaire (SIQR)(Changes from Baseline to 3-month Follow-Up)
- Patient's Global Impression of Change (PGIC)(Changes from Baseline to 3-month Follow-Up)
- Healthcare Utilization(Changes from Baseline to 3-month Follow-Up)
- Satisfaction and Qualitative Questions(3-month Follow-up)
- Quantitative Sensory Testing (QST)(Changes from Baseline to 3-month Follow-Up)
- The Brief Pain Inventory Pain Intensity Scale (BPI)(Changes from Baseline to 3-month Follow-Up)
- MasterMyPain App(Daily ratings over 3-months)
研究者
Robert N. Jamison, PhD
Principal Investigator
Brigham and Women's Hospital