An interventional study of Verum Acupressure (using AcuWand) and Sham Acupressure (using AcuWand) in Sickle Cell Disease, sponsored by Indiana University. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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 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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 59 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Exclusion Criteria:
Participants will continue ongoing usual care and administer self-acupressure treatment.
Device: Verum Acupressure (using AcuWand)
Participants will continue ongoing usual care and administer self-acupressure treatment.
Device: Sham Acupressure (using AcuWand)
The acupressure procedure will consist of medium-deep pressure using a tool (AcuWand) to the selected acupoints on their bodies, as tolerated, at each assigned point, applied in a circular motion. Subjects will be trained to perform the treatment appropriately at all points and will complete the first treatment under supervision. Acupressure treatment will last for 2 minutes per point and be administered remotely every other day for 5 weeks.
The sham acupressure procedure will be performed using the same tool and methodology at each assigned sham acupoint. Subjects will be trained to perform the treatment appropriately at all points and will complete the first treatment under supervision. Treatment will be administered remotely every other day for 5 weeks.
Change in Pain Intensity
Intensity of pain will be assessed by Patient-Reported Outcomes Measurement 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 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.)
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 will be scored from 0-19, and Symptom Severity will be scored from 0 to 12. 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 function, anxiety, depression, fatigue, sleep disturbance will be assessed by PROMIS-29, a single 4-20 numeric rating for each measure. Standard T scores relative to the U.S. general population (mean = 50, SD = 10) are calculated; higher values for each measure indicate worse symptoms except for higher physical function values which indicate better physical function.
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
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 12 months before and after the 5-week treatment will be documented.
Time frame: Baseline and 12 months post-treatment
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.
Time frame: Baseline, weekly through Week 5, and daily during VOCs up to 12 months
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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