The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupressure analgesia in patients with sickle cell disease (SCD).
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 6 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
The acupressure procedure will consist of medium-deep pressure as tolerated at each assigned point applied in a circular motion. Subjects will be trained in the appropriate performance of the treatment at all points and complete the first treatment under supervision. Acupressure treatment will last for 2-3 minutes per point and be administered remotely every other day for 5 weeks. Acupressure will be performed using a tool (AcuWand) and a pencil (the pencil's eraser head will be used as an alternative/backup tool) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. In the event AcuWand/pencil is not available, participants can use fingers/thumbs for self-acupressure.
University of California, Irvine
Irvine, California, United States
RECRUITINGIndiana University School of Medicine
Indianapolis, Indiana, United States
RECRUITINGChange in Pain Severity
Severity of pain will be assessed by Brief Pain Inventory (BPI) using the rating from 0= no pain to 10= worst pain imaginable.
Time frame: Baseline and post-week 5 treatment
Change in Pain Interference
Pain interference will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire using the rating from with 4 = minimal interference to 20 = significant interference.
Time frame: Baseline and post-week 5 treatment
Change in Nociplastic Pain Questionnaire
A customized questionnaire that is used to examine the locations (Yes/No) and severity of the pain interference (no problem-slight-moderate-severe) for understanding the level of nociplastic pain in the past 7 days. Widespread Pain Index and Symptom Severity will be scored from 0 to 10. Higher score connotes higher severity of nociplastic pain.
Time frame: Baseline and post-week 5 treatment
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire
Physical dysfunction, anxiety, depression, fatigue, sleep disturbance will be assessed by PROMIS-29, a single 4-20 numeric rating for each question.
Time frame: Baseline and post-week 5 treatment
Change in Multidimensional Fatigue Inventory (MFI) Questionnaire
MFI is a 20-item self-report instrument designed to measure fatigue with five dimensions including General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue.
Time frame: Baseline and post-week 5 treatment
Ying Wang, MD, PhD
CONTACT
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Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire
The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Time frame: Baseline and post-week 5 treatment
Change in Pediatric Quality of Life Inventory (PedsQL, both pediatric and adult versions) Questionnaire
The PedsQL is a self-report and parent-report measure assessing the quality of life in a variety of domains including physical, emotional, social, and school. Items are reverse-scored and transformed to a 0-100 scale where higher scores indicate better quality of life.
Time frame: Baseline and post-week 5 treatment
Change in opioid requirements
Opioid requirements will be assessed by morphine milligram equivalents.
Time frame: Baseline to 3 months post-treatment
Changes in vaso-occlusive crises (VOCs) frequency
The total number of VOCs within 6 months before and after the 5-week treatment will be documented.
Time frame: Baseline and 6 months post-treatment