Integrative Medicine in Pain Management in Sickle Cell Disease, 2.0

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
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
Accepted

Interventions

  • needling acupuncture — DEVICE
    Acupuncture treatment will use 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

First listed
Dec 10, 2024
Start date
Jul 1, 2026
Status verified
Aug 2026
Primary completion
Jun 28, 2030
Completion
Jun 28, 2031

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
University of Cincinnati College of MedicineCincinnatiOhio45229
Ying Wang, MD, PhD
[email protected]
513-653-0746
Ying Wang, MD, PhD
[email protected]
513-556-9364

Find similar trials in Cincinnati, OH

Nationwide
Sickle cell disease trials
By condition
Sickle cell disease
By research site
University of Cincinnati College of Medicine· Cincinnati, OH

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