Integrative Medicine in Pain Management in Sickle Cell Disease, 2.0

NCT06725550 | Recruiting DMC FDA Device

• 1 other identifier: 25633
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupuncture analgesia in patients with sickle cell disease.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Functional brain connectivity characteristics

  Characteristics of functional brain activity will be studied using fMRI.

  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.

  changes of quantitative sensory testing scores from baseline to post-treatment time point (approximately 5 weeks interval)

Secondary Outcomes (11)

• Brain metabolites characteristics

  changes of brain metabolites levels from baseline to post-treatment time point (approximately 5 weeks interval)

• painDETECT Questionnaire

  changes of painDETECT scores from baseline to post-treatment time point (approximately 5 weeks interval)

• Brief Pain Inventory (BPI) Questionnaire

  changes of BPI scores from baseline to post-treatment time point (approximately 5 weeks interval)

• Nociplastic Pain Questionnaire

  changes of nociplastic scores from baseline to post-treatment time point (approximately 5 weeks interval)

• Hospital Anxiety and Depression Scale (HADS) Questionnaire

  changes of HADS scores from baseline to post-treatment time point (approximately 5 weeks interval)

Other Outcomes (8)

• Circulating biomarkers' profile and levels

  changes of circulating biomarkers levels from baseline to post-treatment time point (approximately 5 weeks interval)

• Blood hemoglobin level

  changes of blood hemoglobin level from baseline to post-treatment time point (approximately 5 weeks interval)

• Brain hemodynamic activity

  changes of brain hemodynamic activity from baseline to post-treatment time point (approximately 5 weeks interval)

Study Arms (4)

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.

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.

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.

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.

Device: laser acupuncture

Interventions

needling acupuncture DEVICE

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.

Needling Acupuncture - 12 weeks; Needling Acupuncture - 5 weeks

laser acupuncture DEVICE

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.

Laser Acupuncture - 12 weeks; Laser Acupuncture - 5 weeks

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender
• (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.
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46075, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 34418575 BACKGROUND

• 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)

  RESULT

• 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)

  RESULT

• 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)

  RESULT

Related Links

• Indiana CTSI Study Listing

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ying Wang, MD, PhD

CONTACT

317-278-5045; ywa12@iu.edu

Ying Wang, MD, PhD

CONTACT

317-406-5047; ywanglab@iupui.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 30, 2030
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)