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Behavioural Intervention
Acupressure for Sickle Cell Disease
N/A
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 14-17 (Adolescents) and 18-80 (Adults)
Diagnosed with SCD and experiencing chronic pain in the past 6 months or vaso-occlusive crisis/crises in the past 12 months
Must not have
History of head injury with substantial loss of consciousness
Known non-SCD-related severe psychiatric illnesses (e.g. current schizophrenia, major depression with suicidal ideation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weekly through week 5, and daily during vocs up to 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how effective acupressure is in reducing pain in patients with sickle cell disease, and to understand the biological reasons behind its effectiveness.
Who is the study for?
This trial is for adolescents and adults aged 14-80 with Sickle Cell Disease who have had chronic pain or a vaso-occlusive crisis in the past year. Participants must speak English, give consent, limit other pain treatments during the study, and commit to bi-daily acupressure sessions for 5 weeks.
What is being tested?
The study tests the effectiveness of acupressure analgesia on patients with Sickle Cell Disease. It involves two types of acupressure techniques to understand how they relieve pain and their underlying neurological mechanisms.
What are the potential side effects?
Acupressure is generally considered safe but may cause temporary soreness at pressure points, minor bruising, or light-headedness. Since it's non-invasive, serious side effects are rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 14 and 80 years old.
Select...
I have sickle cell disease and have had chronic pain or a pain crisis in the last year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a head injury that caused me to lose consciousness significantly.
Select...
I do not have severe psychiatric conditions like schizophrenia or major depression with suicidal thoughts.
Select...
I do not have severe vision, hearing, or movement problems that would stop me from participating in study activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weekly through week 5, and daily during vocs up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weekly through week 5, and daily during vocs up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pain Interference
Change in Pain Severity
Secondary study objectives
Change in Multidimensional Fatigue Inventory (MFI) Questionnaire
Change in Nociplastic Pain Questionnaire
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire
+4 moreOther study objectives
Blood Hemoglobin Level
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care + AcupressureExperimental Treatment1 Intervention
Participants will continue ongoing usual care and administer self-acupressure treatment.
Group II: Usual Care OnlyActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of California, IrvineOTHER
566 Previous Clinical Trials
1,932,808 Total Patients Enrolled
Indiana UniversityLead Sponsor
1,044 Previous Clinical Trials
1,316,629 Total Patients Enrolled