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| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care + Verum Acupressure | Experimental | Participants will continue ongoing usual care and administer self-acupressure treatment. |
|
| Usual Care + Sham Acupressure | Sham Comparator | Participants will continue ongoing usual care and administer self-acupressure treatment. |
|
| Usual Care Only | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum Acupressure (using AcuWand) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.) | Baseline and post-week 5 treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92868 | United States | ||
| Indiana University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40343035 | Derived | Houran L, Pucka AQ, Jiang M, Liu Z, O'Brien AR, Harte SE, Harris RE, Pakbaz Z, Wang Y. Acupressure alleviates pain and clinical symptoms in patients with sickle cell disease. medRxiv [Preprint]. 2025 May 1:2025.04.29.25326671. doi: 10.1101/2025.04.29.25326671. |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| Sham Acupressure (using AcuWand) | Device | 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. |
|
| 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. | 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 |
| Indianapolis |
| Indiana |
| 46075 |
| United States |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |