No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
14 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
University of Cincinnati · Other
Who this trial is looking for
This trial is looking for patients with sickle cell disease who experience chronic pain. Participants will receive acupuncture treatments and complete various tests over five weeks.
Are You a Good Fit for This Trial?
Must be takingHydroxyureaL-glutamineCrizanlizumabVoxelotor
Must not be takingStimulant medications
Rules you outThrombocytopeniaWorker's Compensation claims
You may be able to join if
I am 14 to 80 years old
I have been diagnosed with sickle cell disease
I have chronic pain or have had a pain crisis in the last year
I can travel to the study site for scheduled visits
I am willing to limit new medications for pain during the study
I am right-handed
I can speak and understand English
I am not pregnant or nursing
You may not be able to join if
I have Covid-19 or suspected Covid-19
I have used acupuncture for pain management in the last 6 months
I have a bleeding disorder that affects safe acupuncture use
I have a severe autoimmune or inflammatory disease causing pain
I have a recent head injury with loss of consciousness
I have severe psychiatric illness
I have any condition that would make MRI unsafe for me
I am involved in legal claims related to my sickle cell disease
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupuncture analgesia in patients with sickle cell disease.
Trial Locations
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City
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Status
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 mon…
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.
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