Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2018-10-23
2022-10-13
Brief Summary
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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.
Detailed Description
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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
1. Treatment group: Participants with SCD hospitalized for acute pain who agree to receive acupuncture (standard of care treatment plus acupuncture)
2. 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. .
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
acupuncture
The acupuncture will be provided by the licensed acupuncturist using standard methods.
Control Arm
Standard of care for SCD patients who are hospitalized for acute pain and typically includes IV opioids, ketorolac and fluids.
No interventions assigned to this group
Interventions
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acupuncture
The acupuncture will be provided by the licensed acupuncturist using standard methods.
Eligibility Criteria
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Inclusion Criteria
* Admitted for management of pain at Children's National.
* Ability to provide informed consent/assent
Exclusion Criteria
* 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
8 Years
22 Years
ALL
No
Sponsors
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Deepika Darbari
OTHER
Responsible Party
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Deepika Darbari
Associate Professor of Pediatrics, Division of Hematology
Principal Investigators
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Deepika Darbari, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
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Children's National Health System
Washington D.C., District of Columbia, United States
Countries
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References
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Reece-Stremtan S, Mahmood L, Margulies S, Martin B, Rohatgi R, Idiokitas R, Cohen IT, Zhang A, Thaniel L, Hardy SJ, Darbari DS. Acupuncture as an Adjunctive Treatment for Pain in Hospitalized Children With Sickle Cell Disease. J Pain Symptom Manage. 2021 Dec;62(6):1239-1244. doi: 10.1016/j.jpainsymman.2021.06.003. Epub 2021 Jun 9.
Other Identifiers
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Pro00010719
Identifier Type: -
Identifier Source: org_study_id