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NCT05045820Active, not recruiting

Integrative Medicine in Pain Management in Sickle Cell Disease

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
106 (actual)
First submitted
25 Aug 2021
Start date
29 Jun 2021
Primary completion date
20 Jun 2025
Lead sponsor
Indiana University
NCT number
NCT05045820

What you commit to

  • Study type: Interventional
  • Participants enrolled: 106
  • From 29 Jun 2021 to the primary completion date, 20 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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).
  • 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.

Other illness

  • Subjects with Covid-19 suspicion or confirmation
  • 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
  • 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.

Lab values

  • 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.

Other

  • Recent/ongoing alternative pain management with acupuncture or acupuncture-related techniques within the last 6-months.
  • Pregnant or nursing.

Who the study is looking for

  • 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.

Age in the registry: 14 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Indiana University School of Medicine
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.