search
Back to results

Integrative Medicine in Pain Management in Sickle Cell Disease

Primary Purpose

Sickle Cell Disease, Pain, Acupuncture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupuncture
Sham
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle cell disease, Pain, Acupuncture, Quantitative Sensory Testing, Magnetic Resonance Imaging, Circulating Biomarkers, Electroencephalography, Functional Near-infrared Spectroscopy

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • Subjects with ongoing VOC (or hospitalization during enrollment will not be scheduled for QST and MRI sessions, other scheduled sessions will remain.
  • 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.
  • 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.

Exclusion Criteria:

  • 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
    • 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.

Sites / Locations

  • Indiana University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treatment

Sham

Arm Description

Outcomes

Primary Outcome Measures

Functional brain connectivity characteristics
Characteristics of functional brain activity will be studied using fMRI.
Somatosensory function
Somatosensory functionality will be examined using a board tests of which is a reliable and reproducible approach in pain research.
Brain metabolites characteristics
Characteristics of brain metabolites will be studied using 1H-MRS.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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 0-10 numeric rating for each question.
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.
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.
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.
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.

Full Information

First Posted
August 25, 2021
Last Updated
February 21, 2023
Sponsor
Indiana University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT05045820
Brief Title
Integrative Medicine in Pain Management in Sickle Cell Disease
Official Title
Integrative Medicine in Pain Management in Sickle Cell Disease: Assessing the Clinical Efficacy and Neurobiological Impact With Acupuncture
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 brin 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Pain, Acupuncture, Quantitative Sensory Testing, Magnetic Resonance Imaging, Circulating Biomarkers, Electroencephalography, Functional Near-infrared Spectroscopy
Keywords
Sickle cell disease, Pain, Acupuncture, Quantitative Sensory Testing, Magnetic Resonance Imaging, Circulating Biomarkers, Electroencephalography, Functional Near-infrared Spectroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
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. 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.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
"Non-Tradition Acupuncture" or a "Placebo Comparator" will be used as sham acupuncture which uses "mock laser" acupuncture approach. 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. The laser will not be turned on during the treatment. Sham 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 sham treatment which contains 10 treatment sessions.
Primary Outcome Measure Information:
Title
Functional brain connectivity characteristics
Description
Characteristics of functional brain activity will be studied using fMRI.
Time Frame
changes brain connectivity features from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Somatosensory function
Description
Somatosensory functionality will be examined using a board tests of which is a reliable and reproducible approach in pain research.
Time Frame
changes of quantitative sensory testing scores from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Brain metabolites characteristics
Description
Characteristics of brain metabolites will be studied using 1H-MRS.
Time Frame
changes of brain metabolites levels from baseline to post-treatment time point (approximately 5 weeks interval)
Secondary Outcome Measure Information:
Title
painDETECT Questionnaire
Description
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.
Time Frame
changes of painDETECT scores from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Brief Pain Inventory (BPI) Questionnaire
Description
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.
Time Frame
changes of BPI scores from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Nociplastic Pain Questionnaire
Description
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.
Time Frame
changes of nociplastic scores from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Hospital Anxiety and Depression Scale (HADS) Questionnaire
Description
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.
Time Frame
changes of HADS scores from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Psychological Screening Questionnaires (PHQ-9)
Description
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.
Time Frame
changes of PHQ-9 scores from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Questionnaire
Description
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 0-10 numeric rating for each question.
Time Frame
changes of PROMIS-29 scores from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Multidimensional Fatigue Inventory (MFI) Questionnaire
Description
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.
Time Frame
changes of MFI scores from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Pittsburgh Sleep Quality Index (PSQI) Questionnaire
Description
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.
Time Frame
changes of PSQI scores from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Adult Sickle Cell Quality Measure (ASCQ-ME) Questionnaire
Description
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.
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.
Title
Pediatric Quality of Life Inventory (PedsQL, both pediatric and adult versions) Questionnaire
Description
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.
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.
Other Pre-specified Outcome Measures:
Title
Circulating biomarkers' profile and levels
Description
Circulating biomarkers' expression profile and quantitative level of each targeted biomarker in blood samples will be examined using proteomics, multiplex assays, ELISA and etc.
Time Frame
changes of circulating biomarkers levels from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Blood hemoglobin level
Description
Blood hemoglobin level will be assessed by both regular blood sample analysis and a patented algorithm of spectral super-resolution spectroscopy technique using a software installed smartphone through the participants' inner eyelid.
Time Frame
changes of blood hemoglobin level from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Brain hemodynamic activity
Description
Brain hemodynamic activity will be recorded and examined by functional near-infrared spectroscopy.
Time Frame
changes of brain hemodynamic activity from baseline to post-treatment time point (approximately 5 weeks interval)
Title
Brain structural characteristics
Description
Brain structural features will also be examined using MRI.
Time Frame
changes of brain structural characteristics from baseline to post-treatment time point (approximately 5 weeks interval)
Title
brain electrophysiological characteristics: EEG power in alpha band
Description
Brain electrophysiological signals will be recorded and examined by EEG. EEG power in alpha band will be analyzed using Matlab, EEGLab or other computer software designed for EEG data.
Time Frame
changes of alpha band from baseline to post-treatment time point (approximately 5 weeks interval)
Title
brain electrophysiological characteristics: EEG power in theta band
Description
Brain electrophysiological signals will be recorded and examined by EEG. EEG power in theta band will be analyzed using Matlab, EEGLab or other computer software designed for EEG data.
Time Frame
changes of theta band from baseline to post-treatment time point (approximately 5 weeks interval)
Title
brain electrophysiological characteristics: EEG power in beta band
Description
Brain electrophysiological signals will be recorded and examined by EEG. EEG power in beta band will be analyzed using Matlab, EEGLab or other computer software designed for EEG data.
Time Frame
changes of beta band from baseline to post-treatment time point (approximately 5 weeks interval)
Title
brain electrophysiological characteristics: EEG power in delta band
Description
Brain electrophysiological signals will be recorded and examined by EEG. EEG power in delta band will be analyzed using Matlab, EEGLab or other computer software designed for EEG data.
Time Frame
changes of delta band from baseline to post-treatment time point (approximately 5 weeks interval)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Subjects with ongoing VOC (or hospitalization during enrollment will not be scheduled for QST and MRI sessions, other scheduled sessions will remain. 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. 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. Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang, MD, PhD
Phone
317-278-5045
Email
ywa12@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang, MD, PhD
Phone
317-406-5047
Email
ywanglab@iupui.edu
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Wang
Phone
317-278-5045
Email
ywa12@iu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34418575
Citation
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.
Results Reference
background
Citation
TJ 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 Reference
result
Citation
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)
Results Reference
result
Citation
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)
Results Reference
result
Links:
URL
https://research-studies.allinforhealth.info/us/en/listing/11381/adultadultsteenteensteenagerteenagersadolescentadolescentssickle-cellsickle-cell-diseasepain-integrative-medicine-in-pain-management-in-sickle-cell-disease-assessing-the-clinical-efficacy-and-neurobiological-impact-with-acupuncture/
Description
Indiana CTSI Study Listing

Learn more about this trial

Integrative Medicine in Pain Management in Sickle Cell Disease

We'll reach out to this number within 24 hrs