Integrative Medicine in Pain Management in Sickle Cell Disease, 2.0

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06725550
Status
Recruiting
Apply to this trial

Conditions

  • Acupuncture
  • Circulating Biomarkers
  • Electroencephalography
  • Functional Near-infrared Spectroscopy
  • Magnetic Resonance Imaging
  • Pain
  • Quantitative Sensory Testing
  • Sickle Cell Disease

Eligibility Criteria

Sex
ALL
Age
14 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Aug 25, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2029
Completion
Aug 30, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Functional brain connectivity characteristics [ Time Frame: changes brain connectivity features from baseline to post-treatment time point (approximately 5 weeks interval) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of MedicineIndianapolisIndiana46075
Ying Wang
[email protected]
317-278-5045

Find similar trials in Indianapolis, IN

By condition
Sickle cell disease
By research site
Indiana University School of Medicine· Indianapolis, IN

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