Acupuncture for Pain in Sickle Cell Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04122378|
Recruitment Status : Active, not recruiting
First Posted : October 10, 2019
Last Update Posted : July 25, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
Sickle cell disease (SCD) is the most common genetic disorder in the United States affecting approximately 100,000 individuals primarily of African ancestry. Pain is the most common complication of SCD. Currently, the mainstay therapy for pain in SCD is opioids. The CDC recommends using non-opioid, non-pharmacologic therapies for pain. There is a growing body of literature to support the use of various integrative therapies for pain.
Acupuncture therapy is a non-pharmacological Chinese medicine approach which has been used in many non-SCD conditions associated with pain. Proposed study will test acceptability and feasibility of use of acupuncture in SCD patients hospitalized for pain. It is hypothesized that the use of acupuncture as an adjuvant therapy will be acceptable to SCD patients admitted for pain control. Its impact on opioid use and circulating cytokines and neuropeptides will also be determined.
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Other: acupuncture||Not Applicable|
This study will evaluate the acceptability and tolerability of acupuncture in patients with SCD admitted for management of acute pain. SCD patients admitted for pain control will be approached for the study. The participants agreeing to receive acupuncture will receive acupuncture once daily for upto 5 days or the day of discharge.
For the primary endpoint of the study, the investigators will determine the proportions of eligible patients/families that are willing to accept acupuncture with their standard of care management of pain. The investigators anticipate ≥60% of patients will agree to accept acupuncture as part of their inpatient pain management.
The investigators also aim to explore whether the use of acupuncture affects opioid use during hospitalization. This secondary endpoint will evaluate opioid use in morphine milligram equivalent (MME) while hospitalized and other outcomes (side effects, pain control and function) which will be compared between the following two groups of patients
- Treatment group: Participants with SCD hospitalized for acute pain who agree to receive acupuncture (standard of care treatment plus acupuncture)
- Control group: Participants with SCD hospitalized for acute pain who decline to receive acupuncture (standard of care treatment alone) but agree to serve as controls to allow the study team to collect data on pain-related outcomes (secondary end-points above).
This study will also explore if acupuncture modifies the concentration of circulating cytokines and neuropeptides in the study participants. The study team will draw blood at baseline before acupuncture treatment and on the day of discharge or when the decision to discharge to home will be made by the inpatient team. Concentrations of circulating cytokines and neuropeptides will be compared between the groups. .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Proposed study is a feasibility study of acupuncture therapy in patients with SCD admitted for management of acute pain. The primary goal of proposed study is to determine (1) if acupuncture is acceptable modality for management of pain in patients with SCD. The investigators will also explore (2) if acupuncture improves pain outcomes in SCD and (3) if use of acupuncture is associated with modulation of cytokines.|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Acupuncture for the Treatment of Pain in Sickle Cell Disease|
|Actual Study Start Date :||October 23, 2018|
|Estimated Primary Completion Date :||October 23, 2025|
|Estimated Study Completion Date :||October 23, 2026|
Experimental: Treatment Arm
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.
The acupuncture will be provided by the licensed acupuncturist using standard methods.
No Intervention: Control Arm
Standard of care for SCD patients who are hospitalized for acute pain and typically includes IV opioids, ketorolac and fluids.
- Recruitment ratio [ Time Frame: Duration of the study upto 5 years ]Number of participants with SCD hospitalized for acute pain who enroll in the study on the acupuncture arm /total number of SCD patients hospitalized for acute pain who enroll in the study will be assessed. This information will determine if acupuncture is a acceptable treatment modality for patients with SCD hospitalized for pain.
- Opioid use in morphine milligram equivalents (MME) [ Time Frame: Duration of hospitalization up to 5 days ]Opioid use in MME will be calculated in both group of study participants (acupuncture with standard of care arm and standard of care arm) to determine if there are any difference in opioid use between the groups.
- Concentration of circulating cytokines and neuropeptides [ Time Frame: Duration of hospitalization up to 5 days ]Circulating cytokines and neuropeptide will be measured in the participants of both groups (acupuncture with standard of care arm and standard of care arm) at baseline and on discharge or day 5 whatever occurs first to determine if there are any differences in concentration of circulating cytokines and neuropeptides between the groups.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||8 Years to 22 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- subjects with SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSOArab)
- Admitted for management of pain at Children's National.
- Ability to provide informed consent/assent
- Inability to give informed consent/assent as determined by the investigators
- SCD related complications such as acute chest syndrome requiring supplemental oxygen, fever with bacteremia or concern for serious infection ex. osteomyelitis Local -skin infection or condition not feasible for acupuncture
- Pregnancy or lactation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122378
|United States, District of Columbia|
|Children's National Health System|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Deepika Darbari, MD||Children's National Research Institute|
|Responsible Party:||Deepika Darbari, Associate Professor of Pediatrics, Division of Hematology, Children's National Research Institute|
|Other Study ID Numbers:||
|First Posted:||October 10, 2019 Key Record Dates|
|Last Update Posted:||July 25, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||There is no plan to make individual participant data available to other researchers.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn