Sickle Cell DiseaseNCT06511453
Acupressure in Patients With Sickle Cell Disease
A study testing Verum Acupressure (using AcuWand) in people with Sickle Cell Disease, run by Indiana University at 2 sites in United States.
Trial summary
The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupressure analgesia in patients with sickle cell disease (SCD). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Verum Acupressure (using AcuWand)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2024to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University School of Medicine
Indianapolis, Indiana, 46075
University of California, Irvine
Irvine, California, 92868
About this study
Official title: Remote Self-Administered Acupressure for Pain Management in Patients With Sickle Cell Disease
The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupressure analgesia in patients with sickle cell disease (SCD).
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Verum Acupressure (using AcuWand), Sham Acupressure (using AcuWand)
- Keywords
- Sickle Cell Disease, Pain, Acupressure, Inner Eyelid Imaging
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum Acupressure (using AcuWand)Device
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.
Sham Acupressure (using AcuWand)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care + Verum Acupressure | Experimental | Participants will continue ongoing usual care and administer self-acupressure treatment. Receives: Device: Verum Acupressure (using AcuWand) |
| Usual Care + Sham Acupressure | Sham comparator | Participants will continue ongoing usual care and administer self-acupressure treatment. Receives: Device: Sham Acupressure (using AcuWand) |
| Usual Care Only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Intensity of pain will be assessed by Patient-Reported Outcomes Measurement using the rating from 0= no pain to 10= worst pain imaginable.
Measured: Baseline and post-week 5 treatment
Change in Pain Interference
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.)
Measured: Baseline and post-week 5 treatment
Secondary outcomes (7)
Change in Nociplastic Pain Questionnaire
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.
Measured: Baseline and post-week 5 treatment
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire
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.
Measured: Baseline and post-week 5 treatment
Change in Multidimensional Fatigue Inventory (MFI) Questionnaire
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.
Measured: Baseline and post-week 5 treatment
Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire
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.
Measured: Baseline and post-week 5 treatment
Change in Pediatric Quality of Life Inventory (PedsQL, both pediatric and adult versions) Questionnaire
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.
Measured: Baseline and post-week 5 treatment
Change in opioid requirements
Opioid requirements will be assessed by morphine milligram equivalents.
Measured: Baseline to 3 months post-treatment
Changes in vaso-occlusive crises (VOCs) frequency
The total number of VOCs within 12 months before and after the 5-week treatment will be documented.
Measured: Baseline and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start7 Mar 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Principal investigator, Ying Wang, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511453
- Sponsor's protocol ID
- 10056b
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Houran L, Pucka AQ, Jiang M, Liu Z, O'Brien AR, Harte SE, Harris RE, Pakbaz Z, Wang Y. Acupressure alleviates pain and clinical symptoms in patients with sickle cell disease. medRxiv [Preprint]. 2025 May 1:2025.04.29.25326671. doi: 10.1101/2025.04.29.25326671.
PubMed 40343035
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Self-Administered Acupressure for Pain Management in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06511453
- Acronym / sponsor ID
- 10056b
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Pain, Acupressure, Inner Eyelid Imaging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care + Verum Acupressure | Experimental | Device: Verum Acupressure (using AcuWand)Participants will continue ongoing usual care and administer self-acupressure treatment. |
| Usual Care + Sham Acupressure | Sham comparator | Device: Sham Acupressure (using AcuWand)Participants will continue ongoing usual care and administer self-acupressure treatment. |
| Usual Care Only | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum 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. | Device | Usual Care + Verum Acupressure |
| Sham 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. | Device | Usual Care + Sham Acupressure |
Primary outcome
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.
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.)
7 secondary outcomes
Change in Nociplastic Pain Questionnaire
Time frame: Baseline and post-week 5 treatment
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire
Time frame: Baseline and post-week 5 treatment
Change in Multidimensional Fatigue Inventory (MFI) Questionnaire
Time frame: Baseline and post-week 5 treatment
Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire
Time frame: Baseline and post-week 5 treatment
Change in Pediatric Quality of Life Inventory (PedsQL, both pediatric and adult versions) Questionnaire
Time frame: Baseline and post-week 5 treatment
Change in opioid requirements
Time frame: Baseline to 3 months post-treatment
Changes in vaso-occlusive crises (VOCs) frequency
Time frame: Baseline and 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 40343035Houran L, Pucka AQ, Jiang M, Liu Z, O'Brien AR, Harte SE, Harris RE, Pakbaz Z, Wang Y. Acupressure alleviates pain and clinical symptoms in patients with sickle cell disease. medRxiv [Preprint]. 2025 May 1:2025.04.29.25326671. doi: 10.1101/2025.04.29.25326671.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum Acupressure (using AcuWand) in people with Sickle Cell Disease, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline and post-week 5 treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06511453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.