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Active, Not Recruiting

NCT Number: NCT06511453

Acupressure 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine, Irvine, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Pain Intensity

    Time frame: Baseline and post-week 5 treatment

    Intensity of pain will be assessed by Patient-Reported Outcomes Measurement using the rating from 0= no pain to 10= worst pain imaginable.

  2. Change in Pain Interference

    Time frame: Baseline and post-week 5 treatment

    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.)

Secondary outcomes

  1. Change in Nociplastic Pain Questionnaire

    Time frame: Baseline and post-week 5 treatment

    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.

  2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire

    Time frame: Baseline and post-week 5 treatment

    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.

  3. Change in Multidimensional Fatigue Inventory (MFI) Questionnaire

    Time frame: Baseline and post-week 5 treatment

    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.

  4. Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire

    Time frame: Baseline and post-week 5 treatment

    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.

  5. Change in Pediatric Quality of Life Inventory (PedsQL, both pediatric and adult versions) Questionnaire

    Time frame: Baseline and post-week 5 treatment

    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.

  6. Change in opioid requirements

    Time frame: Baseline to 3 months post-treatment

    Opioid requirements will be assessed by morphine milligram equivalents.

  7. Changes in vaso-occlusive crises (VOCs) frequency

    Time frame: Baseline and 12 months post-treatment

    The total number of VOCs within 12 months before and after the 5-week treatment will be documented.

Other outcomes

  1. Blood Hemoglobin Level

    Time frame: Baseline, weekly through Week 5, and daily during VOCs up to 12 months

    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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • University of California, Irvine

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2031
Study completion
2032
First posted
Jul 22, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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