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New treatment option for Sickle Cell Disease
Official title Integrative Medicine in Pain Management in Sickle Cell Disease, 2.0
ClinicalTrials.gov ID: NCT06725550
What this study is testing
- What it's testing
- The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupuncture analgesia in patients with sickle cell disease.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 80
You may be able to join if
- 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...
You likely can't join if
- people 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...
- Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease...
- Diseases/conditions history includes but not limited to:
- head injury with substantial loss of consciousness
See the full eligibility 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...
- 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, people will primarily be African-American or of African descent, although there are individuals with SCD who come from Hispanic...
- Fluent in English and capable of giving written informed consent.
- people 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...
- 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...
- 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...
- 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...
- History vascular surgery in lower limbs or current lower limb vascular dysfunction will not receive conditioned pressure pain stimuli in the lower limb.
- people 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...
- Participation of other studies: Concurrent participation in other therapeutic trials with overlapping research purposes.
- Pregnant or nursing.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.