Acupressure in Patients With Sickle Cell Disease

N/AActive Not RecruitingNCT06511453

Indiana University300 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Sickle Cell Disease

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of California, Irvine

Irvine, California, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.)

Time frame: Baseline and post-week 5 treatment

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline and post-week 5 treatment

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.

Data from ClinicalTrials.gov

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