Clinical trial NCT06511453: Acupressure in Patients With Sickle Cell Disease
Official title: Remote Self-Administered Acupressure for Pain Management in Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Pain
Acupressure
Inner Eyelid Imaging
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
First posted: 2024-07-22
Enrollment: 240
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Severity
timeFrame: Baseline and post-week 5 treatment
measure: Change in Pain Interference
timeFrame: Baseline and post-week 5 treatment
Secondary outcomes:
measure: Change in Nociplastic Pain Questionnaire
timeFrame: Baseline and post-week 5 treatment
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire
timeFrame: Baseline and post-week 5 treatment
measure: Change in Multidimensional Fatigue Inventory (MFI) Questionnaire
timeFrame: Baseline and post-week 5 treatment
measure: Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire
timeFrame: Baseline and post-week 5 treatment
measure: Change in Pediatric Quality of Life Inventory (PedsQL, both pediatric and adult versions) Questionnaire
timeFrame: Baseline and post-week 5 treatment
measure: Change in opioid requirements
timeFrame: Baseline to 3 months post-treatment
measure: Changes in vaso-occlusive crises (VOCs) frequency
timeFrame: Baseline and 6 months post-treatment
Other outcomes:
measure: Blood Hemoglobin Level
timeFrame: Baseline, weekly through Week 5, and daily during VOCs up to 6 months
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
References: