Clinical trial NCT04156399: Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study
Official title: Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: sickle cell disease
pain
chronic pain
acupuncture
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is an unblinded, uncontrolled trial.
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators long-term goal is to demonstrate the effectiveness of acupuncture for the treatment of adults with chronic pain due to sickle cell disease (SCD), a debilitating pain syndrome characterized by acute and chronic pain. The objective of this study is to explore the feasibility and acceptability of acupuncture with adult patients with SCD. All participants will receive acupuncture treatments twice per week for 5 weeks. Subjects will complete measures at baseline and post-treatment, and a measure of study acceptability at post-treatment. The investigators will describe the procedures and potential challenges to implementing the acupuncture protocol, and expect to identify and rectify any procedural problems that subjects report regarding the 10-session study protocol.

Detailed description: The investigators will conduct the study with adults with chronic pain from SCD, 18 years old or greater. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will complete measures that include pain, fatigue, anxiety, depressive symptoms, injustice experience, and pain catastrophizing. Subjects will also complete a measure of study acceptability, the Protocol Acceptability Scale for Treating SCD with Acupuncture at post-treatment. The investigators will describe the procedures and potential challenges to implementing the acupuncture protocol and the range in the subjects' Acceptability Scale scores. The investigators will expect to identify and rectify any procedural problems that subjects will report regarding the 10-session study protocol.

Eligibility criteria: Inclusion Criteria:

* Adults with Sickle Cell Disease
* Receiving care at the University of Illinois Sickle Cell Disease clinic
* Moderate to severe level of pain (3 or higher on a 0-10 scale) within the last 3 months

Exclusion Criteria:

* Pregnancy
* Physically or cognitively unable to complete the study procedures

Primary outcomes:
measure: Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD.
timeFrame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
measure: Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture
timeFrame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago College of Nursing
state: Illinois
Study officials:
affiliation: UIC
name: Judith M Schlaeger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li H, Patil CL, Molokie RE, Njoku F, Steffen AD, Doorenbos AZ, Schlaeger JM. Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study. Acupunct Med. 2021 Dec;39(6):612-618. doi: 10.1177/09645284211017303. Epub 2021 Jun 3.