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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
Sponsor:
Information provided by (Responsible Party):
Deepika Darbari, Children's National Research Institute

Study Description
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Brief Summary:

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

Detailed Description:

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

  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. .

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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Arm Intervention/treatment
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.
 Other: acupuncture
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects with SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSOArab)
  • Admitted for management of pain at Children's National.
  • Ability to provide informed consent/assent

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, District of Columbia
Children's National Health System
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Deepika Darbari
Investigators
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Principal Investigator: Deepika Darbari, MD Children's National Research Institute
More Information
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Responsible Party: Deepika Darbari, Associate Professor of Pediatrics, Division of Hematology, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT04122378    
Other Study ID Numbers: Pro00010719
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.

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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
Keywords provided by Deepika Darbari, Children's National Research Institute:
Pain, Acupuncture
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn