RecruitingNot applicable

Integrative Medicine in Pain Management in Sickle Cell Disease, 2.0

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 14 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participation in this study will include 14 study visits over around 6-8 weeks and 12 months follow-up visits."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether acupuncture, a treatment using thin needles, helps relieve sickle cell pain. It also looks at how acupuncture affects the brain and nerves. It is for people ages 14–80 with sickle cell disease and recent long-term pain or a pain crisis.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be ages 14–80 and right-handed. People of any gender or ethnic background may join.
  • Have sickle cell disease and long-term pain in the past 6 months or a pain crisis from blocked blood flow in the past 12 months.
  • You may be staying in a hospital, receiving care outside a hospital, or moving between the two.
  • Prescribed pain medicines and other sickle cell treatments are allowed but not required.
  • Be willing to limit current and new medicines or other pain treatments during study visits.
  • Be able to travel for scheduled surveys, pain-sensitivity tests, brain-wave tests (EEG), and brain scans (MRI).
  • Be able to receive acupuncture up to twice a week for 5 weeks.
  • Speak English fluently and be able to give written consent to join.

Who can't join

  • Have suspected or confirmed COVID-19, or be pregnant or breastfeeding.
  • Have used acupuncture or related pain treatments in the past 6 months, or be in another treatment study with overlapping goals.
  • Have a bleeding problem or low platelets, the blood cells that help stop bleeding, that could make acupuncture unsafe. Some people with mildly low platelets may be considered.
  • Have an immune-system or swelling-related disease that causes pain, or another long-term pain condition that hurts more than sickle cell pain.
  • Have a past head injury with a major loss of consciousness; nerve damage with a known cause that limits daily tasks; a severe mental illness not related to sickle cell disease; or sight, movement, or hearing problems that limit study tasks.
  • Have started or changed the dose of a stimulant medicine in the past 30 days, including medicines for attention problems or certain sleep-related tiredness.
  • Have sickle cell–related workers’ compensation, legal, or disability claims, be involved in a settlement, or currently receive money from these claims.
  • Some conditions limit only certain tests: people with MRI safety risks, such as certain metal implants, heart rhythm problems, or seizures, will not have MRI visits. People with past leg blood-vessel surgery or current leg blood-flow problems will not receive pressure-pain testing in the leg.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

OH