Acupressure in Patients With Sickle Cell Disease
NCT Number: NCT06511453
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sickle Cell Disease
Interventions: OTHER: Acupressure 1|OTHER: Acupressure 2
Sponsor: Indiana University
Collaborators: University of California, Irvine
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-07
Completion Date: 2030-03
Locations: University of California, Irvine, Irvine, California, 92868, United States|Indiana University School of Medicine, Indianapolis, Indiana, 46075, United States

Summary:
The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupressure analgesia in patients with sickle cell disease (SCD).

Primary Outcome Measures: Change in Brief Pain Inventory (BPI) Questionnaire, A simplified BPI is used to assess the severity of pain, interference of pain on daily function, location of pain, pain medications and amount of pain relief using the rating from 0= no pain/relief/interference to 10= worst pain imaginable/complete relief/completely interferes in the past 24 hours or the past week., Baseline and post-week 5 treatment
Secondary Outcome Measures: 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., Baseline and post-week 5 treatment|Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire, The PROMIS-29 has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) with customized 29-item questions and a single 0-10 numeric rating for each question., 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., Baseline and post-week 5 treatment|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., 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., Baseline and post-week 5 treatment|Change in opioid requirements, Opioid requirements will be assessed by morphine milligram equivalents., Baseline to 3 months post-treatment|Changes in vaso-occlusive crises (VOCs) frequency, The total number of VOCs within 12 months before and after the 5-week treatment will be documented., Baseline and 12 months post-treatment
Other Outcome Measures: Blood Hemoglobin Level, Blood hemoglobin level will be assessed using self-collected images of the participants' inner eyelid via a patented algorithm of spectral super-resolution spectroscopy technique., Baseline, weekly through Week 5, and daily during VOCs up to 6 months