Remote Self-Administered Acupressure for Pain Management in Patients With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in Pain Interference
研究概览
简要总结
The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupressure analgesia in patients with sickle cell disease (SCD).
详细描述
This study will help the investigators learn whether acupressure, a non-pharmacological alternative treatment approach, can help manage pain in patients with sickle cell disease. Acupressure involves the application of pressure stimulation at specific acupoints on the body. Acupressure may help relieve pain and is used for a wide variety of pain conditions. Participation in this study will consist of remote self-administered treatment every other day over 5 weeks, followed by 12 months of remote follow-up visits. During participation, subjects will: 1) receive detailed instruction on locating treatment acupoints and completing study procedures remotely, 2) be assigned a treatment kit, 3) answer questions about their personal and health-related information for assessing their health condition before, during, and after the treatment during follow-up sessions, and 4) collect inner eyelid images for examining the hemoglobin level on a weekly basis at steady phase and daily basis during acute vaso-occlusive crisis stage.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any gender
- •18-80 (Adults) years old
- •Have been diagnosed with SCD and experiencing chronic pain in the past 6 months or vaso-occlusive crisis/crises in the past 12 months.
- •Either outpatient or inpatient or status changing between each other
- •Willing to limit the current and the introduction of any new medications or treatment modalities for control of pain symptoms during the study visits.
- •Willing to stick to the scheduled acupressure treatments every other day for 5 weeks.
- •Fluent in English and capable of giving written informed consent.
排除标准
- •Recent/ongoing alternative pain management with acupuncture/acupressure or acupuncture/acupressure-related techniques within the last 6 months.
- •Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain or any other chronic pain condition with pain greater than sickle pain.
- •Diseases/conditions history includes but not limited to:
- •Head injury with substantial loss of consciousness
- •Known non-SCD-related severe psychiatric illnesses (e.g. current schizophrenia, major depression with suicidal ideation).
- •Significant visual, motor, or auditory impairment that would interfere with ability to perform study visits-related activities
研究组 & 干预措施
Usual Care Only
Usual Care + Verum Acupressure
Participants will continue ongoing usual care and administer self-acupressure treatment.
干预措施: Verum Acupressure (using AcuWand) (Device)
Usual Care + Sham Acupressure
Participants will continue ongoing usual care and administer self-acupressure treatment.
干预措施: Sham Acupressure (using AcuWand) (Device)
结局指标
主要结局
Change in Pain Interference
时间窗: Baseline and post-week 5 treatment
Pain interference will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire using raw scores (rating from with 4 = minimal interference to 20 = significant interference) and T scores (ranges from approximately 41 to 75, with a mean of 50 and a standard deviation of 10, based on the US general population. A higher score indicates greater pain interference.)
Change in Pain Intensity
时间窗: Baseline and post-week 5 treatment
Intensity of pain will be assessed by Patient-Reported Outcomes Measurement using the rating from 0= no pain to 10= worst pain imaginable.
次要结局
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire(Baseline and post-week 5 treatment)
- Change in Nociplastic Pain Questionnaire(Baseline and post-week 5 treatment)
- Change in Multidimensional Fatigue Inventory (MFI) Questionnaire(Baseline and post-week 5 treatment)
- Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire(Baseline and post-week 5 treatment)
- Change in Pediatric Quality of Life Inventory (PedsQL, both pediatric and adult versions) Questionnaire(Baseline and post-week 5 treatment)
- Change in opioid requirements(Baseline to 3 months post-treatment)
- Changes in vaso-occlusive crises (VOCs) frequency(Baseline and 12 months post-treatment)
研究者
Ying Wang
Assistant Professor of Anesthesia
Indiana University