Integrative Medicine in Pain Management in Sickle Cell Disease

Launched by INDIANA UNIVERSITY · Sep 14, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring how effective acupuncture can be in managing pain for people with sickle cell disease (SCD). Researchers want to understand not only if acupuncture helps reduce pain but also how it works in the brain. They are looking for participants aged 14 to 80 who have been diagnosed with SCD and are experiencing ongoing pain. Eligible participants should be willing to limit new pain medications during the study and be able to travel to the study site for treatments and assessments.

Participants in the trial can expect to receive acupuncture treatments up to two times a week for five weeks. They will also take part in various tests to help researchers gather information about their pain and the effects of acupuncture. It's important to note that individuals with certain health conditions or those currently involved in other studies may not qualify for this trial. This research aims to provide better pain management options for those living with sickle cell disease.

Gender

ALL

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.