Acupressure in Patients With Sickle Cell Disease

NCT ID: NCT06511453

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-07

Study Completion Date

2029-08-31

Brief Summary

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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).

Detailed Description

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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 6 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.

Conditions

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Sickle Cell Disease

Keywords

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Sickle Cell Disease Pain Acupressure Inner Eyelid Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual Care + Acupressure

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

Group Type EXPERIMENTAL

Acupressure (using AcuWand or pencil eraser)

Intervention Type DEVICE

The acupressure procedure will consist of medium-deep pressure as tolerated at each assigned point applied in a circular motion. Subjects will be trained in the appropriate performance of the treatment at all points and complete the first treatment under supervision. Acupressure treatment will last for 2-3 minutes per point and be administered remotely every other day for 5 weeks.

Acupressure will be performed using a tool (AcuWand) and a pencil (the pencil's eraser head will be used as an alternative/backup tool) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. In the event AcuWand/pencil is not available, participants can use fingers/thumbs for self-acupressure.

Usual Care Only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupressure (using AcuWand or pencil eraser)

The acupressure procedure will consist of medium-deep pressure as tolerated at each assigned point applied in a circular motion. Subjects will be trained in the appropriate performance of the treatment at all points and complete the first treatment under supervision. Acupressure treatment will last for 2-3 minutes per point and be administered remotely every other day for 5 weeks.

Acupressure will be performed using a tool (AcuWand) and a pencil (the pencil's eraser head will be used as an alternative/backup tool) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. In the event AcuWand/pencil is not available, participants can use fingers/thumbs for self-acupressure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any gender
* 14-17 (Adolescents) and 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Irvine

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Ying Wang

Assistant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, Irvine

Irvine, California, United States

Site Status RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ying Wang, MD, PhD

Role: CONTACT

Phone: 317-278-5045

Email: [email protected]

Ying Wang, MD, PhD

Role: CONTACT

Facility Contacts

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Zahra Pakbaz, MD

Role: primary

Ying Wang, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40343035 (View on PubMed)

Other Identifiers

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10056b

Identifier Type: -

Identifier Source: org_study_id