Recruiting

Acupuncture Analgesia

Sponsor:

University of Cincinnati

Code:

NCT06725550

Conditions

Sickle Cell Disease

Pain

Acupuncture

Quantitative Sensory Testing

Magnetic Resonance Imaging

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Accepted

Interventions

needling acupuncture

laser acupuncture

Study Details

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

Study ID

NCT06725550

Start date

Jul 1, 2026

Status verified date

Aug, 2026

Completion date

Jun 28, 2031

Anticipated

Primary completion date

Jun 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Accepted

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.
  • 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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

needling acupuncture

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

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.

Primary outcome measure

  • Functional brain connectivity characteristics [ Time Frame: changes brain connectivity features from baseline to post-treatment time point (approximately 5 weeks interval) ]
  • Somatosensory function [ Time Frame: changes of quantitative sensory testing scores from baseline to post-treatment time point (approximately 5 weeks interval) ]

Central Contacts and Locations

Central contacts

Locations

University of Cincinnati College of Medicine

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

More Information

Sponsor

University of Cincinnati

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-08-12.