Sickle Cell Disease
Conditions
Keywords
Sickle Cell Disease, Pain, Acupressure, Inner Eyelid Imaging
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 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.
Interventions
DEVICEVerum Acupressure (using AcuWand)
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.
DEVICESham Acupressure (using AcuWand)
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.
Sponsors
Indiana University
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | Baseline and post-week 5 treatment | Intensity of pain will be assessed by Patient-Reported Outcomes Measurement 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 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 will be scored from 0-19, and Symptom Severity will be scored from 0 to 12. 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 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. |
| 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 12 months post-treatment | The total number of VOCs within 12 months before and after the 5-week treatment will be documented. |
Countries
United States
Outcome results
None listed