Auricular Point Acupressure to Manage Pain in Patients With Alzheimer's Disease and Related Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change of Quantitative Sensory Testing (QST)
研究概览
简要总结
Pain is considered as one of the most important causal factors of behavioral and psychological symptoms in patients Alzheimer's disease and related disorders (ADRD). The investigators plan to examine the effectiveness of pain relief, pain sensory change and immune biomarkers change (measured by serum biomarkers) after the auricular point acupressure (APA). A waitlist will be used to examine the feasibility of a 4-week APA intervention. The investigators will also explore potential analgesic pathways and underpinnings of APA on pain relief.
详细描述
A waitlist pilot study will be conducted to examine the feasibility of a 4-week APA intervention. Participants and their caregivers will be enrolled into the study. Following the baseline assessment (1st home visit), participants will wait one month and will be randomized to an interventionist or caregiver-training group.
Both groups will have a home/office visit at pre-intervention, followed by three home visits weekly, and a final home/office visit at post-intervention. Participants in both groups will have 1 monthly follow-up phone call after the completion of APA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a diagnosis of possible or probable ADRD by National Institute of Aging (NIA) and Alzheimer's Association Guidelines,
- •have a caregiver who is able to help and manage APA,
- •pain that has persisted at least 3 months and pain on at least half of the days for the previous 6 months,
- •average intensity of pain ≥ 4 on a 10 point numerical pain scale in the past 7 days,
- •receiving care at the Johns Hopkins Memory and Alzheimer's Treatment Center (JHMATC), Johns Hopkins Alzheimer's disease Research Center (JHADRC),
- •willing to commit to 5-weekly study visits (first office visits and followed by home visits) by the study coordinators and two follow-up home visits (at three- and six-months follow-up),
- •have any type of dementia, mild to moderate stages (Montreal Cognitive Assessment, MoCA, ≥ 8),
- •caregiver is willing to participate.
排除标准
- •concurrent major psychiatric disorder (e.g. major depressive disorder (as primary diagnosis), bipolar disorder, schizophrenia) or drug and alcohol abuse,
- •severe illness or pain that would lead to significant deterioration in health, or that would limit participation in the interventions (e.g. metastatic cancer, musculoskeletal disorders, etc.)
结局指标
主要结局
Change of Quantitative Sensory Testing (QST)
时间窗: Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
It will be measured by cold pressor testing, conditional pain modulation, mechanical pain threshold. The percentage of change score (from each end point to baseline) will be used (0-100).
Change of Neuropsychiatric Inventory Questionnaire (NPI-Q)
时间窗: Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
Assess the presence (yes or no) and the severity of ten neuropsychiatric symptoms. The possible range of scores is 0-36 with 0 being least severe and 36 being most severe
Change of Caregiver Burden Interview
时间窗: Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
It will be measured using Zarit Burden.The Zarit Burden Interview, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire . The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a scale. Response options usually range from 0 (Never) to 4 (Nearly Always) The score ranges from 0 to 48.the greater the score, the higher the burden.
Change of Inflammatory Cytokines
时间窗: Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
It will be measured by blood serum.
Change of Pain intensity
时间窗: Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
It will be measured by Brief Pain Inventory (score 0-10 for pain intensity, with 0 for no pain and 10 for most severe pain. score 0-70 for pain interferences
Change of Neuropsychiatric Inventory Caregiver Distress (NPI-D)
时间窗: Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
It is used to assess caregiver's distress. The range of the scale is from 0-60 with 0 being least distress and 60 being most distress
Change of Quality of life in Alzheimer's Disease (QOL-AD)
时间窗: Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
Total scores range from 13 to 52.
次要结局
未报告次要终点