Acupuncture for Pain in Sickle Cell Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sickle Cell Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 8 years and 22 years
- Gender
- Both males and females
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 upt...
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. .
Tracking Information
- NCT #
- NCT04122378
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Deepika Darbari, MD Children's National Research Institute
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