Acupressure in Patients With Sickle Cell Disease

NCT06511453 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 10056b
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Pain; Acupressure; Inner Eyelid Imaging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in Nociplastic Pain Questionnaire

  Baseline and post-week 5 treatment

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

  Baseline and post-week 5 treatment

• Change in Multidimensional Fatigue Inventory (MFI) Questionnaire

  Baseline and post-week 5 treatment

• Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire

  Baseline and post-week 5 treatment

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

  Baseline and post-week 5 treatment

Other Outcomes (1)

• Blood Hemoglobin Level

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

Study Arms (3)

Usual Care + Verum Acupressure

EXPERIMENTAL

Participants will continue ongoing usual care and administer self-acupressure treatment.

Device: Verum Acupressure (using AcuWand)

Usual Care + Sham Acupressure

SHAM COMPARATOR

Participants will continue ongoing usual care and administer self-acupressure treatment.

Device: Sham Acupressure (using AcuWand)

Usual Care Only

NO INTERVENTION

Interventions

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.

Usual Care + Verum Acupressure

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.

Usual Care + Sham Acupressure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender
• (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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• University of California, Irvine: collaborator

Study Sites (2)

University of California, Irvine

Irvine, California, 92868, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46075, United States

Location

Related Publications (1)

• 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.

  PMID: 40343035 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 22, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): May 1, 2032
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)