Acupressure in Patients With Sickle Cell Disease
- Conditions
- Sickle Cell Disease
- Interventions
- Device: Acupressure (using AcuWand or pencil eraser)
- Registration Number
- NCT06511453
- Lead Sponsor
- Indiana University
- Brief Summary
The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupressure analgesia in patients with sickle cell disease (SCD).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care + Acupressure Acupressure (using AcuWand or pencil eraser) Participants will continue ongoing usual care and administer self-acupressure treatment.
- Primary Outcome Measures
Name Time Method Change in Pain Severity Baseline and post-week 5 treatment Severity of pain will be assessed by Brief Pain Inventory (BPI) using the rating from 0= no pain to 10= worst pain imaginable.
Change in Pain Interference Baseline and post-week 5 treatment Pain interference will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire using the rating from with 4 = minimal interference to 20 = significant interference.
- Secondary Outcome Measures
Name Time Method Change in Nociplastic Pain Questionnaire 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 and Symptom Severity will be scored from 0 to 10. Higher score connotes higher severity of nociplastic pain.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire Baseline and post-week 5 treatment Physical dysfunction, anxiety, depression, fatigue, sleep disturbance will be assessed by PROMIS-29, a single 4-20 numeric rating for each question.
Change in Multidimensional Fatigue Inventory (MFI) Questionnaire 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.
Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire 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.
Change in Pediatric Quality of Life Inventory (PedsQL, both pediatric and adult versions) Questionnaire 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.
Change in opioid requirements Baseline to 3 months post-treatment Opioid requirements will be assessed by morphine milligram equivalents.
Changes in vaso-occlusive crises (VOCs) frequency Baseline and 6 months post-treatment The total number of VOCs within 6 months before and after the 5-week treatment will be documented.
Trial Locations
- Locations (2)
University of California, Irvine
🇺🇸Irvine, California, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States