Remote Self-Administered Acupressure for Pain Management in Patients With Sickle Cell Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Indiana University
- Enrollment
- 59
- Locations
- 2
- Primary Endpoint
- Change in Pain Interference
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Usual Care Only
Usual Care + Verum Acupressure
Participants will continue ongoing usual care and administer self-acupressure treatment.
Intervention: Verum Acupressure (using AcuWand) (Device)
Usual Care + Sham Acupressure
Participants will continue ongoing usual care and administer self-acupressure treatment.
Intervention: Sham Acupressure (using AcuWand) (Device)
Outcomes
Primary Outcomes
Change in Pain Interference
Time Frame: 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.)
Change in Pain Intensity
Time Frame: 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.
Secondary Outcomes
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire(Baseline and post-week 5 treatment)
- Change in Nociplastic Pain 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, both pediatric and adult versions) Questionnaire(Baseline and post-week 5 treatment)
- Change in opioid requirements(Baseline to 3 months post-treatment)
- Changes in vaso-occlusive crises (VOCs) frequency(Baseline and 12 months post-treatment)
Investigators
Ying Wang
Assistant Professor of Anesthesia
Indiana University