Sickle Cell DiseaseNCT05045820
Integrative Medicine in Pain Management in Sickle Cell Disease
A study testing needling acupuncture and laser acupuncture in people with Sickle Cell Disease and Pain, run by Indiana University at 1 site in United States.
Trial summary
The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupuncture analgesia in patients with sickle cell disease. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Sickle Cell Disease, Pain, Acupuncture
- What is being tested?
- needling acupuncture and laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 20 Aug 2026
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any gender
- 14-17 (Adolescents) and 18-80 (Adults) years old
- Right-handed
- Either outpatient or inpatient or status changing between each other
- Have been diagnosed with SCD (includes but not limited to SS, SC or other type) and experiencing chronic pain in the past 6 months or vaso-occlusive crisis (VOC) in the past 12 months.
- Analgesic therapy prescribed by primary hematologists (or physicians for emergency or primary care) including pain-relieving medications (e.g. Morphine, coderin, Fentanyl, Oxycodone), Hydroxyurea (e.g. Droxia, Hydrea, Siklos), L-glutamine oral powder (Endari), Crizanlizumab (Adakveo), Voxelotor (Oxbryta), and/or other palliative treatment allowed, not required.
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- Willing to limit the current and the introduction of any new medications or treatment modalities for control of pain symptoms during the study visits.
- Able to travel to the study site for participating scheduled visits (questionnaires, QST, EEG and MRI) and receive acupuncture treatments up to two times weekly for 5 weeks as scheduled.
- We will recruit without regard to ethnicity, however, due to the genetic nature of SCD, subjects will primarily be African-American or of African descent, although there are individuals with SCD who come from Hispanic, southern European, Middle Eastern, or Asian Indian backgrounds. The ethnic distribution in our prior studies is 95% Black/African American with 5% Hispanic or Latino (of any race). As these are minority groups many individuals may be from lower income situations.
- Fluent in English and capable of giving written informed consent.
Who cannot join
- Subjects with Covid-19 suspicion or confirmation
- Recent/ongoing alternative pain management with acupuncture or acupuncture-related techniques within the last 6-months.
- Presence of a known coagulation abnormality: Thrombocytopenia (mild thrombocytopenia with a platelets range of 51,000-100,000/ul will be further evaluated for inclusion consideration), or bleeding diathesis that may preclude the safe use of acupuncture.
- 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
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- peripheral neuropathy of known cause that interferes with activities of daily living
- 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
- Medication:
- Recent (30 days) initiation or dose adjustment of stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/dextroamphetamine [Adderall®], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil).
- Contraindications to MRI scans includes but are not limited to: surgical clips, surgical staples, metal implants, cardiac rhythmic disorders, seizure disorders, and certain metallic dental material will not be scheduled for MRI visits.
- History vascular surgery in lower limbs or current lower limb vascular dysfunction will not receive conditioned pressure pain stimuli in the lower limb.
- Subjects with Worker's Compensation, Workman's Compensation, civil litigation or disability claims pertinent to the subject's sickle disease; current involvement in out-of-court settlements for claims pertinent to the subject's sickle disease; or currently receiving monetary compensation as a result of any of the above.
- Participation of other studies: Concurrent participation in other therapeutic trials with overlapping research purposes.
- Pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46075
About this study
Official title: Integrative Medicine in Pain Management in Sickle Cell Disease: Assessing the Clinical Efficacy and Neurobiological Impact With Acupuncture
The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupuncture analgesia in patients with sickle cell disease.
Read the detailed description
This study will help the investigators to learn whether acupuncture, which is a non-opioid alternative pain management approach, can help to manage pain in patients with sickle cell disease and the underlying mechanisms. Acupuncture involves inserting very fine needles through the skin at specific points on the body to different depths. Acupuncture may help relieve pain and it is used for a wide range of pain conditions. Participation in this study will include 14 study visits over around 6-8 weeks and 12 months follow-up visits. This is a randomized study, which means subjects are randomly assigned to one of two groups. During the study visits: 1) Subjects will be randomized to 10 sessions with either traditional acupuncture (very fine acupuncture needles will be inserted into the skin) or laser acupuncture without needles (a laser acupuncture device will be used and there will be no physical contact between the device and subject's skin) and each session will last for 30 minutes, 2) Subjects will answer questions about their personal and health related information for assessing health condition during the in-person and follow-up study visits, 3) Investigators will perform quantitative sensory testing (QST) before and after the acupuncture sessions on the surface of selected testing areas in subjects to assess the somatosensory functionality, 4) Investigators will record brain signals before and after acupuncture sessions using magnetic resonance imaging (MRI)-an imaging tool to analyze brain structural and functional features and metabolites profile, functional near-infrared spectroscopy (fNIRS)-an imaging tool to examine the brain hemodynamic activity, and electroencephalography (EEG) -an imaging tool used to detect the brain electrical activity, 5) Subjects will receive evoked pain stimuli on the left gastrocnemius muscle during MRI, fNIRS and EEG, 6) Female subjects will take a urine pregnancy test during the screening visit as well as before each behavioral and MRI visit, 7) Investigators will collect an inner eyelid image collection for examining the hemoglobin level and 8) subjects will have two blood draws before and after the entire acupuncture sessions for regular blood examination and circulating biomarkers' analyses. Some details regarding the interventions are purposefully omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
- Conditions
- Sickle Cell Disease, Pain, Acupuncture, Quantitative Sensory Testing, Magnetic Resonance Imaging, Circulating Biomarkers
- Being tested
- needling acupuncture, laser acupuncture
- Keywords
- Sickle cell disease, Pain, Acupuncture, Quantitative Sensory Testing, Magnetic Resonance Imaging, Circulating Biomarkers, Electroencephalography, Functional Near-infrared Spectroscopy
- 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.
needling acupunctureDevice
Acupuncture treatment will both main and supplementary acupoints. Main points include GB30; ST36; LI11- LI4, GB34-SP6; LR3, SP10, DU24, DU20, Yin Tang, Ear Shen Men which are chosen based on the unique clinical features of sickle pain. The remaining individualized acupoints will be selected and manipulated with manual acupuncture with appropriate needling techniques based on the individual "Syndrome" ("reinforce" or "reduce" or "Non reinforce or reduce") that is determined by TCM diagnosis.
laser acupunctureDevice
Laser acupuncture device VitaLaser 650 (Lhasa OMS, Weymouth, MA or similar) will be positioned 1-2cm over all of the same acupoints used in verum acupuncture treatment above. No palpation is administered prior to positioning the device and there is no physical contact between device and skin.
| Study group | Role | What they receive |
|---|---|---|
| Needling Acupuncture - 5 weeks | Experimental | Needling acupuncture treatment will last 30 minutes per session and will be administered two times per week for 5 weeks. Each subject will receive one course of treatment which contains 10 treatment sessions. Receives: Device: needling acupuncture |
| Laser Acupuncture - 5 weeks | Experimental | Laser acupuncture treatment will also last 30 minutes per session and will be administered two times per week for 5 weeks. Each subject will receive one course of laser acupuncture treatment which contains 10 treatment sessions. Receives: Device: laser acupuncture |
| Needling Acupuncture - 12 weeks | Experimental | Needling acupuncture treatment will last 30 minutes per session and will be administered once per week for 12 weeks. Each subject will receive one course of treatment which contains 12 treatment sessions. Receives: Device: needling acupuncture |
| Laser Acupuncture - 12 weeks | Experimental | Laser acupuncture treatment will also last 30 minutes per session and will be administered once per week for 12 weeks. Each subject will receive one course of laser acupuncture treatment which contains 12 treatment sessions. Receives: Device: laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain connectivity characteristics
Characteristics of functional brain activity will be studied using fMRI.
Measured: changes brain connectivity features from baseline to post-treatment time point (approximately 5 weeks interval)
Somatosensory function
Somatosensory functionality will be examined using a board tests of which is a reliable and reproducible approach in pain research.
Measured: changes of quantitative sensory testing scores from baseline to post-treatment time point (approximately 5 weeks interval)
Secondary outcomes (11)
Brain metabolites characteristics
Characteristics of brain metabolites will be studied using 1H-MRS.
Measured: changes of brain metabolites levels from baseline to post-treatment time point (approximately 5 weeks interval)
painDETECT Questionnaire
This is 4-component questionnaires that address the location, intensity, quality of pain symptoms. painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain.
Measured: changes of painDETECT scores from baseline to post-treatment time point (approximately 5 weeks interval)
Brief Pain Inventory (BPI) Questionnaire
A simplified BPI is used to assess the severity of pain, interference of pain on daily function, location of pain, pain medications and amount of pain relief using the rating from 0= no pain/relief/interference to 10= worst pain imaginable/complete relief/completely interferes in the past 24 hours or the past week.
Measured: changes of BPI scores from baseline to post-treatment time point (approximately 5 weeks interval)
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 and Symptom Severity will be scored from 0 to 10. Higher score connotes higher severity of nociplastic pain.
Measured: changes of nociplastic scores from baseline to post-treatment time point (approximately 5 weeks interval)
Hospital Anxiety and Depression Scale (HADS) Questionnaire
HADS is used to determine the levels of anxiety and depression that a person is experiencing in the past one week. The HADS is a fourteen-item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Measured: changes of HADS scores from baseline to post-treatment time point (approximately 5 weeks interval)
Psychological Screening Questionnaires (PHQ-9)
PHQ-9 is used to assess the mental health conditions in the past two weeks. Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe, and severe depression, respectively.
Measured: changes of PHQ-9 scores from baseline to post-treatment time point (approximately 5 weeks interval)
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire
The PROMIS-29 has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) with customized 29-item questions and a single 4-20 numeric rating for each question.
Measured: changes of PROMIS-29 scores from baseline to post-treatment time point (approximately 5 weeks interval)
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: changes of MFI scores from baseline to post-treatment time point (approximately 5 weeks interval)
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: changes of PSQI scores from baseline to post-treatment time point (approximately 5 weeks interval)
Adult Sickle Cell Quality Measure (ASCQ-ME) Questionnaire
ASCQ-Me contains both questionnaires of pain episodes frequency, severity, and the pain impact that can comprehensively examine the disease severity and impact in pain, stiffness, sleep, social function in patients with SCD. Scores for ASCQ-Me impact scales range from 0 to 100, with a standardized SCD population mean of 50 (SD, 10), where lower scores connote worse disease impact.
Measured: changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit.
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: changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start29 Jun 2021
- Primary completion20 Jun 2025
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ying Wang, Indiana University
- Investigators
- Ying Wang, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045820
- Sponsor's protocol ID
- 10056a
- Other IDs
- 5R00AT010012
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2021
- 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
Wang Y, Hardy SJ, Ichesco E, Zhang P, Harris RE, Darbari DS. Alteration of grey matter volume is associated with pain and quality of life in children with sickle cell disease. Transl Res. 2022 Feb;240:17-25. doi: 10.1016/j.trsl.2021.08.004. Epub 2021 Aug 19.
PubMed 34418575W Li, AQ Pucka, L Houran, XQ Huang, C Debats, B Reyes, AR O'Brien, QG Yu*, Y Wang* . Soluble immune checkpoint landscape in sickle cell disease links systemic inflammation, autoimmunity, and pain. Frontiers of Hematology (2025). Doi: 10.3389/fihem.2025.1580009.
Kish B, Yao JF, Frels AJ, Budde J, Vijayakrishnan Nair V, Pucka AQ, Liu Z, O'Brien AR, Tong Y, Wang Y. Novel identifications of cerebral hemodynamics using BOLD fMRI in patients with sickle cell disease. Imaging Neurosci (Camb). 2025 May 16;3:IMAG.a.1. doi: 10.1162/IMAG.a.1. eCollection 2025.
PubMed 40800810Wang Y, Wang DD, Pucka AQ, O'Brien ARW, Harte SE, Harris RE. Differential clinical characteristics across traditional Chinese medicine (TCM) Syndromes in patients with sickle cell disease. Front Pain Res (Lausanne). 2024 Jan 5;4:1233293. doi: 10.3389/fpain.2023.1233293. eCollection 2023.
PubMed 38249565Li W, Pucka AQ, Debats C, Reyes BA, Syed F, O'Brien ARW, Mehta R, Manchanda N, Jacob SA, Hardesty BM, Greist A, Harte SE, Harris RE, Yu Q, Wang Y. Inflammation and autoimmunity are interrelated in patients with sickle cell disease at a steady-state condition: implications for vaso-occlusive crisis, pain, and sensory sensitivity. Front Immunol. 2024 Feb 1;15:1288187. doi: 10.3389/fimmu.2024.1288187. eCollection 2024.
PubMed 38361924Zhou X, Ichesco E, Pucka AQ, Liu Z, O'Brien AR, Harte SE, Harris RE, Wang Y. Elevated posterior insula glutamate in patients with sickle cell disease. J Pain. 2025 Feb;27:104743. doi: 10.1016/j.jpain.2024.104743. Epub 2024 Nov 28.
PubMed 39615812TJ Barrett, A Pucka, B Reyes, SA Jacob, ARW O'Brien, RE Harris, SE Harte, Y Wang*. Acupuncture Alleviates Pain and Improves Quality of Life in Patients with Sickle Cell Disease. Blood. (2022);140 (Supplement 1):5444-5445. (https://doi.org/10.1182/blood-2022-169013)
JX Yao, ARW O'Brien, YJ Tong*, Y Wang*. A Novel Finding in Cerebral Blood Flow in Patients with Sickle Cell Disease Using Bold Functional MRI. Blood (2022) 140 (Supplement 1): 5433-5434. (https://doi.org/10.1182/blood-2022-167594)
SM Park, YY Ji, S Kwon, ARW O'Brien, Y Wang*, YL Kim*. Association of Noninvasive Peripheral Blood Hemoglobin Assessments with Venous Blood Draws Among Sickle Cell Patients. Blood (2022) 140 (Supplement 1): 7832-7833. (https://doi.org/10.1182/blood-2022-165132)
Joo P, Kim M, Kish B, Nair VV, Tong Y, Liu Z, O'Brien ARW, Harte SE, Harris RE, Lee U, Wang Y. Brain network hypersensitivity underlies pain crises in sickle cell disease. Sci Rep. 2024 Mar 27;14(1):7315. doi: 10.1038/s41598-024-57473-5.
PubMed 38538687
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
- Integrative Medicine in Pain Management in Sickle Cell Disease: Assessing the Clinical Efficacy and Neurobiological Impact With Acupuncture
- ClinicalTrials.gov ID
- NCT05045820
- Acronym / sponsor ID
- 10056a
- Conditions
- Sickle Cell Disease, Pain, Acupuncture, Quantitative Sensory Testing, Magnetic Resonance Imaging, Circulating Biomarkers
- Keywords
- Sickle cell disease, Pain, Acupuncture, Quantitative Sensory Testing, Magnetic Resonance Imaging, Circulating Biomarkers, Electroencephalography, Functional Near-infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 16 Sep 2021 (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 acupuncture analgesia in patients with sickle cell disease.
Detailed description
This study will help the investigators to learn whether acupuncture, which is a non-opioid alternative pain management approach, can help to manage pain in patients with sickle cell disease and the underlying mechanisms. Acupuncture involves inserting very fine needles through the skin at specific points on the body to different depths. Acupuncture may help relieve pain and it is used for a wide range of pain conditions. Participation in this study will include 14 study visits over around 6-8 weeks and 12 months follow-up visits. This is a randomized study, which means subjects are randomly assigned to one of two groups. During the study visits: 1) Subjects will be randomized to 10 sessions with either traditional acupuncture (very fine acupuncture needles will be inserted into the skin) or laser acupuncture without needles (a laser acupuncture device will be used and there will be no physical contact between the device and subject's skin) and each session will last for 30 minutes, 2) Subjects will answer questions about their personal and health related information for assessing health condition during the in-person and follow-up study visits, 3) Investigators will perform quantitative sensory testing (QST) before and after the acupuncture sessions on the surface of selected testing areas in subjects to assess the somatosensory functionality, 4) Investigators will record brain signals before and after acupuncture sessions using magnetic resonance imaging (MRI)-an imaging tool to analyze brain structural and functional features and metabolites profile, functional near-infrared spectroscopy (fNIRS)-an imaging tool to examine the brain hemodynamic activity, and electroencephalography (EEG) -an imaging tool used to detect the brain electrical activity, 5) Subjects will receive evoked pain stimuli on the left gastrocnemius muscle during MRI, fNIRS and EEG, 6) Female subjects will take a urine pregnancy test during the screening visit as well as before each behavioral and MRI visit, 7) Investigators will collect an inner eyelid image collection for examining the hemoglobin level and 8) subjects will have two blood draws before and after the entire acupuncture sessions for regular blood examination and circulating biomarkers' analyses. Some details regarding the interventions are purposefully omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Needling Acupuncture - 5 weeks | Experimental | Device: needling acupunctureNeedling acupuncture treatment will last 30 minutes per session and will be administered two times per week for 5 weeks. Each subject will receive one course of treatment which contains 10 treatment sessions. |
| Laser Acupuncture - 5 weeks | Experimental | Device: laser acupunctureLaser acupuncture treatment will also last 30 minutes per session and will be administered two times per week for 5 weeks. Each subject will receive one course of laser acupuncture treatment which contains 10 treatment sessions. |
| Needling Acupuncture - 12 weeks | Experimental | Device: needling acupunctureNeedling acupuncture treatment will last 30 minutes per session and will be administered once per week for 12 weeks. Each subject will receive one course of treatment which contains 12 treatment sessions. |
| Laser Acupuncture - 12 weeks | Experimental | Device: laser acupunctureLaser acupuncture treatment will also last 30 minutes per session and will be administered once per week for 12 weeks. Each subject will receive one course of laser acupuncture treatment which contains 12 treatment sessions. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Any gender
- 14-17 (Adolescents) and 18-80 (Adults) years old
- Right-handed
- Either outpatient or inpatient or status changing between each other
- Have been diagnosed with SCD (includes but not limited to SS, SC or other type) and experiencing chronic pain in the past 6 months or vaso-occlusive crisis (VOC) in the past 12 months.
Key exclusion criteria (16 listed)
- Subjects with Covid-19 suspicion or confirmation
- Recent/ongoing alternative pain management with acupuncture or acupuncture-related techniques within the last 6-months.
- Presence of a known coagulation abnormality: Thrombocytopenia (mild thrombocytopenia with a platelets range of 51,000-100,000/ul will be further evaluated for inclusion consideration), or bleeding diathesis that may preclude the safe use of acupuncture.
- 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:
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 |
|---|---|---|
| needling acupunctureAcupuncture treatment will both main and supplementary acupoints. Main points include GB30; ST36; LI11- LI4, GB34-SP6; LR3, SP10, DU24, DU20, Yin Tang, Ear Shen Men which are chosen based on the unique clinical features of sickle pain. The remaining individualized acupoints will be selected and manipulated with manual acupuncture with appropriate needling techniques based on the individual "Syndrome" ("reinforce" or "reduce" or "Non reinforce or reduce") that is determined by TCM diagnosis. | Device | Needling Acupuncture - 12 weeks, Needling Acupuncture - 5 weeks |
| laser acupunctureLaser acupuncture device VitaLaser 650 (Lhasa OMS, Weymouth, MA or similar) will be positioned 1-2cm over all of the same acupoints used in verum acupuncture treatment above. No palpation is administered prior to positioning the device and there is no physical contact between device and skin. | Device | Laser Acupuncture - 12 weeks, Laser Acupuncture - 5 weeks |
Primary outcome
Functional brain connectivity characteristics
Time frame: changes brain connectivity features from baseline to post-treatment time point (approximately 5 weeks interval)
Characteristics of functional brain activity will be studied using fMRI.
Somatosensory function
Time frame: changes of quantitative sensory testing scores from baseline to post-treatment time point (approximately 5 weeks interval)
Somatosensory functionality will be examined using a board tests of which is a reliable and reproducible approach in pain research.
11 secondary outcomes
Brain metabolites characteristics
Time frame: changes of brain metabolites levels from baseline to post-treatment time point (approximately 5 weeks interval)
painDETECT Questionnaire
Time frame: changes of painDETECT scores from baseline to post-treatment time point (approximately 5 weeks interval)
Brief Pain Inventory (BPI) Questionnaire
Time frame: changes of BPI scores from baseline to post-treatment time point (approximately 5 weeks interval)
Nociplastic Pain Questionnaire
Time frame: changes of nociplastic scores from baseline to post-treatment time point (approximately 5 weeks interval)
Hospital Anxiety and Depression Scale (HADS) Questionnaire
Time frame: changes of HADS scores from baseline to post-treatment time point (approximately 5 weeks interval)
Psychological Screening Questionnaires (PHQ-9)
Time frame: changes of PHQ-9 scores from baseline to post-treatment time point (approximately 5 weeks interval)
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire
Time frame: changes of PROMIS-29 scores from baseline to post-treatment time point (approximately 5 weeks interval)
Multidimensional Fatigue Inventory (MFI) Questionnaire
Time frame: changes of MFI scores from baseline to post-treatment time point (approximately 5 weeks interval)
Pittsburgh Sleep Quality Index (PSQI) Questionnaire
Time frame: changes of PSQI scores from baseline to post-treatment time point (approximately 5 weeks interval)
Adult Sickle Cell Quality Measure (ASCQ-ME) Questionnaire
Time frame: changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit.
Pediatric Quality of Life Inventory (PedsQL, both pediatric and adult versions) Questionnaire
Time frame: changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit.
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.
- Background: PubMed 34418575Wang Y, Hardy SJ, Ichesco E, Zhang P, Harris RE, Darbari DS. Alteration of grey matter volume is associated with pain and quality of life in children with sickle cell disease. Transl Res. 2022 Feb;240:17-25. doi: 10.1016/j.trsl.2021.08.004. Epub 2021 Aug 19.
- Results publicationW Li, AQ Pucka, L Houran, XQ Huang, C Debats, B Reyes, AR O'Brien, QG Yu*, Y Wang* . Soluble immune checkpoint landscape in sickle cell disease links systemic inflammation, autoimmunity, and pain. Frontiers of Hematology (2025). Doi: 10.3389/fihem.2025.1580009.
- Results publication: PubMed 40800810Kish B, Yao JF, Frels AJ, Budde J, Vijayakrishnan Nair V, Pucka AQ, Liu Z, O'Brien AR, Tong Y, Wang Y. Novel identifications of cerebral hemodynamics using BOLD fMRI in patients with sickle cell disease. Imaging Neurosci (Camb). 2025 May 16;3:IMAG.a.1. doi: 10.1162/IMAG.a.1. eCollection 2025.
- Results publication: PubMed 38249565Wang Y, Wang DD, Pucka AQ, O'Brien ARW, Harte SE, Harris RE. Differential clinical characteristics across traditional Chinese medicine (TCM) Syndromes in patients with sickle cell disease. Front Pain Res (Lausanne). 2024 Jan 5;4:1233293. doi: 10.3389/fpain.2023.1233293. eCollection 2023.
- Results publication: PubMed 38361924Li W, Pucka AQ, Debats C, Reyes BA, Syed F, O'Brien ARW, Mehta R, Manchanda N, Jacob SA, Hardesty BM, Greist A, Harte SE, Harris RE, Yu Q, Wang Y. Inflammation and autoimmunity are interrelated in patients with sickle cell disease at a steady-state condition: implications for vaso-occlusive crisis, pain, and sensory sensitivity. Front Immunol. 2024 Feb 1;15:1288187. doi: 10.3389/fimmu.2024.1288187. eCollection 2024.
- Results publication: PubMed 39615812Zhou X, Ichesco E, Pucka AQ, Liu Z, O'Brien AR, Harte SE, Harris RE, Wang Y. Elevated posterior insula glutamate in patients with sickle cell disease. J Pain. 2025 Feb;27:104743. doi: 10.1016/j.jpain.2024.104743. Epub 2024 Nov 28.
- Results publicationTJ Barrett, A Pucka, B Reyes, SA Jacob, ARW O'Brien, RE Harris, SE Harte, Y Wang*. Acupuncture Alleviates Pain and Improves Quality of Life in Patients with Sickle Cell Disease. Blood. (2022);140 (Supplement 1):5444-5445. (https://doi.org/10.1182/blood-2022-169013)
- Results publicationJX Yao, ARW O'Brien, YJ Tong*, Y Wang*. A Novel Finding in Cerebral Blood Flow in Patients with Sickle Cell Disease Using Bold Functional MRI. Blood (2022) 140 (Supplement 1): 5433-5434. (https://doi.org/10.1182/blood-2022-167594)
- Results publicationSM Park, YY Ji, S Kwon, ARW O'Brien, Y Wang*, YL Kim*. Association of Noninvasive Peripheral Blood Hemoglobin Assessments with Venous Blood Draws Among Sickle Cell Patients. Blood (2022) 140 (Supplement 1): 7832-7833. (https://doi.org/10.1182/blood-2022-165132)
- Results publication: PubMed 38538687Joo P, Kim M, Kish B, Nair VV, Tong Y, Liu Z, O'Brien ARW, Harte SE, Harris RE, Lee U, Wang Y. Brain network hypersensitivity underlies pain crises in sickle cell disease. Sci Rep. 2024 Mar 27;14(1):7315. doi: 10.1038/s41598-024-57473-5.
- 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.
Ying Wang, MD, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing needling acupuncture and laser acupuncture in people with Sickle Cell Disease and Pain, run by Indiana University at 1 site 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 10 inclusion and 16 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 1 site 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. 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?
Functional brain connectivity characteristics (time frame: changes brain connectivity features from baseline to post-treatment time point (approximately 5 weeks interval)). 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 NCT05045820, which also lists 10 linked publications.
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.