Integrative Medicine in Pain Management in Sickle Cell Disease, 2.0

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-80
SponsorUniversity of Cincinnati

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • needling acupuncture

    Device

    Acupuncture 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

    Device

    Laser 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

120 Participants
are divided into 4 treatment groups
Group A: Needling Acupuncture - 5 weeksExperimental treatment 1 intervention
Group B: Laser Acupuncture - 5 weeksExperimental treatment 1 intervention
Group C: Needling Acupuncture - 12 weeksExperimental treatment 1 intervention
Group D: Laser Acupuncture - 12 weeksExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Functional brain connectivity characteristics

Characteristics of functional brain activity will be studied using fMRI.

Time frame
changes brain connectivity features from baseline to post-treatment time point (approximately 5 weeks interval)
2

Somatosensory function

Somatosensory functionality will be examined using a board tests of which is a reliable and reproducible approach in pain research.

Time frame
changes of quantitative sensory testing scores from baseline to post-treatment time point (approximately 5 weeks interval)

Secondary outcomes

1

Brain metabolites characteristics

Characteristics of brain metabolites will be studied using 1H-MRS.

Time frame
changes of brain metabolites levels from baseline to post-treatment time point (approximately 5 weeks interval)
2

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.

Time frame
changes of painDETECT scores from baseline to post-treatment time point (approximately 5 weeks interval)
3

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.

Time frame
changes of BPI scores from baseline to post-treatment time point (approximately 5 weeks interval)
4

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.

Time frame
changes of nociplastic scores from baseline to post-treatment time point (approximately 5 weeks interval)

Other outcomes

1

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.

Time frame
changes of circulating biomarkers levels from baseline to post-treatment time point (approximately 5 weeks interval)
2

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.

Time frame
changes of blood hemoglobin level from baseline to post-treatment time point (approximately 5 weeks interval)
3

Brain hemodynamic activity

Brain hemodynamic activity will be recorded and examined by functional near-infrared spectroscopy.

Time frame
changes of brain hemodynamic activity from baseline to post-treatment time point (approximately 5 weeks interval)
4

Brain structural characteristics

Brain structural features will also be examined using MRI.

Time frame
changes of brain structural characteristics from baseline to post-treatment time point (approximately 5 weeks interval)

Sponsors and contacts

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