Integrative Medicine in Pain Management in Sickle Cell Disease: Assessing the Clinical Efficacy and Neurobiological Impact With Acupuncture, 2.0

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Contact Information
Primary
Ying Wang, MD, PhD
ywa12@iu.edu
317-278-5045
Backup
Ying Wang, MD, PhD
ywanglab@iupui.edu
317-406-5047
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2030-08-30
Participants
Target number of participants: 120
Treatments
Experimental: Needling Acupuncture - 5 weeks
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.
Experimental: Laser Acupuncture - 5 weeks
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.
Experimental: Needling Acupuncture - 12 weeks
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.
Experimental: Laser Acupuncture - 12 weeks
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.
Sponsors
Leads: Indiana University

This content was sourced from clinicaltrials.gov

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