NCT07875777

Brief Summary

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
67mo left

Started Oct 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2027

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2032

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2033

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

5 years

First QC Date

October 8, 2026

Last Update Submit

October 8, 2026

Conditions

Sickle Cell Disease (SCD)

Keywords

Sickle Cell DiseasePainAcupressureInner 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 (6)

  • 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, adult version) Questionnaire

    Baseline and post-week 5 treatment

  • +1 more secondary outcomes

Other Outcomes (2)

  • Blood Hemoglobin Level

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

  • Changes in vaso-occlusive crises (VOCs) frequency

    Baseline and 12 months post-treatment

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 3 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

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Irvine

Irvine, California, 92697, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • Houran L, Pucka AQ, Jiang M, Liu Z, O'Brien ARW, Harte SE, Harris RE, Pakbaz Z, Wang Y. Acupressure alleviates pain and clinical symptoms in patients with sickle cell disease. Blood Adv. 2025 Dec 9;9(23):6126-6129. doi: 10.1182/bloodadvances.2025016995. No abstract available.

    PMID: 40902081BACKGROUND

Related Links

MeSH Terms

Conditions

Anemia, Sickle CellPain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsSigns and SymptomsPathological 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
Associate Professor

Study Record Dates

First Submitted

October 8, 2026

First Posted

October 15, 2026

Study Start (Estimated)

October 1, 2027

Primary Completion (Estimated)

September 30, 2032

Study Completion (Estimated)

March 31, 2033

Last Updated

October 15, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)