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Acupuncture for Sickle Cell Pain

N/A

Waitlist Available

Led By Deepika Darbari, MD

Research Sponsored by Deepika Darbari

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSOArab)

Be younger than 65 years old

Must not have

Inability to give informed consent/assent as determined by the investigators

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of the study upto 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether acupuncture is an acceptable and feasible treatment for sickle cell disease patients who are hospitalized for pain, and whether it reduces their use of opioids and has an impact on their circulating cytokines and neuropeptides.

Who is the study for?

This trial is for individuals with Sickle Cell Disease (SCD) who are hospitalized for pain management and can give informed consent. It's not suitable for pregnant or lactating women, those with serious infections like osteomyelitis, acute chest syndrome needing oxygen, or skin conditions preventing acupuncture.

What is being tested?

The study is exploring the use of acupuncture as an additional treatment to reduce pain in patients with SCD. The goal is to see if it's a feasible option that patients accept and whether it affects opioid usage and certain blood markers related to pain.

What are the potential side effects?

Acupuncture may cause minor side effects such as soreness, bleeding or bruising at needle sites, dizziness, fainting, and rarely infection. However, many find it less invasive than other medical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have sickle cell disease (SCD) such as HbSS, HbSC, HbSβ0 thalassemia, or HbSOArab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am able to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of the study upto 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of the study upto 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the study upto 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recruitment ratio

Secondary study objectives

Opioid use in morphine milligram equivalents (MME)

Other study objectives

Concentration of circulating cytokines and neuropeptides

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

Acupuncture will be provided up to once daily for one or more days till the day of discharge or 5 days, whichever occurs first. Patients will continue to receive their standard pain management regime including IV opioids, ketorolac and fluids. Minimum number of sessions received by the acupuncture group will be one.

Group II: Control ArmActive Control1 Intervention

Standard of care for SCD patients who are hospitalized for acute pain and typically includes IV opioids, ketorolac and fluids.

0 / 2Eligibility criteria met