Acupuncture for Pain in Sickle Cell Disease

• ClinicalTrials.gov Identifier: NCT04122378
• Recruitment Status: Active, not recruiting
• First Posted: October 10, 2019
• Last Update Posted: July 25, 2022
• Sponsor: Deepika Darbari
• Information provided by (Responsible Party): Deepika Darbari, Children's National Research Institute

Tracking Information

• First Submitted Date: October 2, 2019
• First Posted Date: October 10, 2019
• Last Update Posted Date: July 25, 2022
• Actual Study Start Date: October 23, 2018
• Estimated Primary Completion Date: October 23, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 8, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 8, 2019)

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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 8, 2019)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Acupuncture for Pain in Sickle Cell Disease
• Official Title: A Pilot Study of Acupuncture for the Treatment of Pain in Sickle Cell Disease

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. .

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Sickle Cell Disease

Intervention

Other: acupuncture

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

Study Arms

• 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.
  Intervention: Other: acupuncture
• No Intervention: Control Arm
  Standard of care for SCD patients who are hospitalized for acute pain and typically includes IV opioids, ketorolac and fluids.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 8, 2019): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 23, 2026
• Estimated Primary Completion Date: October 23, 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 22 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04122378
• Other Study ID Numbers: Pro00010719
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: There is no plan to make individual participant data available to other researchers.

• Current Responsible Party: Deepika Darbari, Children's National Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Deepika Darbari
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Deepika Darbari, MD; Children's National Research Institute

• PRS Account: Children's National Research Institute
• Verification Date: July 2022