Acupuncture for Pain in Sickle Cell Disease

NCT04122378 | Completed DMC

• 1 other identifier: Pro00010719
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Pain, Acupuncture

Outcome Measures

Primary Outcomes (1)

• Recruitment ratio

  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.

  Duration of the study upto 5 years

Secondary Outcomes (1)

• Opioid use in morphine milligram equivalents (MME)

  Duration of hospitalization up to 5 days

Other Outcomes (1)

• Concentration of circulating cytokines and neuropeptides

  Duration of hospitalization up to 5 days

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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

Interventions

acupuncture OTHER

The acupuncture will be provided by the licensed acupuncturist using standard methods.

Treatment Arm

Eligibility Criteria

• Age: 8 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deepika Darbari: lead

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• 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.

  PMID: 34118373 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Deepika Darbari, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Division of Hematology

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 10, 2019
• Study Start: October 23, 2018
• Primary Completion: August 1, 2020
• Study Completion: October 13, 2022
• Last Updated: December 4, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)