About this trial
The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupuncture analgesia in patients with sickle cell disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Any gender
14-17 (Adolescents) and 18-80 (Adults) years old
Right-handed
Either outpatient or inpatient or status changing between each other
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
needling acupuncture
DeviceAcupuncture treatment will use both main and supplementary acupoints. Main points include GB30, ST36, LI11, LI4, GB34, SP6, LR3, SP10, DU24, DU20, Yin Tang, Ear Shen Men, which are chosen based on the unique clinical features of sickle pain. The remaining individualized acupoints will be selected and manipulated with manual acupuncture with appropriate needling techniques based on the individual "Syndrome" ("reinforce" or "reduce" or "non-reinforce or reduce") that is determined by TCM diagnosis.
laser acupuncture
DeviceLaser acupuncture device VitaLaser 650 (Lhasa OMS, Weymouth, MA or similar) will be positioned 1-2cm over all of the same acupoints used in verum acupuncture treatment above. No palpation is administered prior to positioning the device and there is no physical contact between device and skin.
Treatment groups
Trial outcomes
Primary outcomes
Functional brain connectivity characteristics
Characteristics of functional brain activity will be studied using fMRI.
Somatosensory function
Somatosensory functionality will be examined using a board tests of which is a reliable and reproducible approach in pain research.
Secondary outcomes
Brain metabolites characteristics
Characteristics of brain metabolites will be studied using 1H-MRS.
painDETECT Questionnaire
This is 4-component questionnaires that address the location, intensity, quality of pain symptoms. painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain.
Brief Pain Inventory (BPI) Questionnaire
A simplified BPI is used to assess the severity of pain, interference of pain on daily function, location of pain, pain medications and amount of pain relief using the rating from 0= no pain/relief/interference to 10= worst pain imaginable/complete relief/completely interferes in the past 24 hours or the past week.
Nociplastic Pain Questionnaire
A customized questionnaire that is used to examine the locations (Yes/No) and severity of the pain interference (no problem-slight-moderate--severe) for understanding the level of nociplastic pain in the past 7 days. Widespread Pain Index and Symptom Severity will be scored from 0 to 10. Higher score connotes higher severity of nociplastic pain.
Other outcomes
Circulating biomarkers' profile and levels
Circulating biomarkers' expression profile and quantitative level of each targeted biomarker in blood samples will be examined using proteomics, multiplex assays, ELISA and etc.
Blood hemoglobin level
Blood hemoglobin level will be assessed by both regular blood sample analysis and a patented algorithm of spectral super-resolution spectroscopy technique using a software installed smartphone through the participants' inner eyelid.
Brain hemodynamic activity
Brain hemodynamic activity will be recorded and examined by functional near-infrared spectroscopy.
Brain structural characteristics
Brain structural features will also be examined using MRI.
Sponsors and contacts
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