Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study

NCT ID: NCT04156399

Last Updated: 2022-04-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2020-03-15

Brief Summary

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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

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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.

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study is an unblinded, uncontrolled trial.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

There is no masking. This study is unblinded.

Study Groups

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Acupuncture

All subjects will receive active acupuncture.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

All subjects will receive a standardized 18 needle acupuncture protocol.

Interventions

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Acupuncture

All subjects will receive a standardized 18 needle acupuncture protocol.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Judith Schlaeger

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith M Schlaeger, PhD

Role: PRINCIPAL_INVESTIGATOR

UIC

Locations

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University of Illinois at Chicago College of Nursing

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34080441 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019-1077

Identifier Type: -

Identifier Source: org_study_id

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