Acupressure in Patients With Sickle Cell Disease

Remote Self-Administered Acupressure for Pain Management in Patients With Sickle Cell Disease

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

Study Overview

• Status: Active, not recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Device: Verum Acupressure (using AcuWand); Device: Sham Acupressure (using AcuWand)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92868
      • University of California, Irvine
  • Indiana
    • Indianapolis, Indiana, United States, 46075
      • Indiana University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Only
Experimental: Usual Care + Verum Acupressure; Participants will continue ongoing usual care and administer self-acupressure treatment.	Device: Verum 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.
Sham Comparator: Usual Care + Sham Acupressure; Participants will continue ongoing usual care and administer self-acupressure treatment.	Device: Sham Acupressure (using AcuWand); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: University of California, Irvine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): May 1, 2032

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Acupressure; Sickle Cell Disease; Inner Eyelid Imaging
• Additional Relevant MeSH Terms: Neurologic Manifestations; Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Pain; Anemia, Sickle Cell
• Other Study ID Numbers: 10056b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No