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NCT Number: NCT04122378

Acupuncture for Pain in Sickle Cell Disease

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.

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Key information

Conditions

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

Age range

8 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Health System

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

About this study

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. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Deepika Darbari

Other

Registry information

Official study title

A Pilot Study of Acupuncture for the Treatment of Pain in Sickle Cell Disease

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Oct 10, 2019
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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