Clinical trial NCT04122378: Acupuncture for Pain in Sickle Cell Disease
Official title: A Pilot Study of Acupuncture for the Treatment of Pain in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Pain, Acupuncture
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 29
Sex: ALL
Minimum age (years): 8
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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. .

Eligibility 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

Primary outcomes:
measure: Recruitment ratio
timeFrame: Duration of the study upto 5 years
Secondary outcomes:
measure: Opioid use in morphine milligram equivalents (MME)
timeFrame: Duration of hospitalization up to 5 days
Other outcomes:
measure: Concentration of circulating cytokines and neuropeptides
timeFrame: Duration of hospitalization up to 5 days
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Deepika Darbari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.