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

February 22, 2022 updated by: Judith Schlaeger, University of Illinois at Chicago
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
All subjects will receive active acupuncture.
Other: Acupuncture
All subjects will receive a standardized 18 needle acupuncture protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD.
Time Frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

Feasibility was measured in terms of participant enrollment and retention and participant completion of study measures. The investigators screened 9 potential participants of which 6 were found to be eligible and all 6 consented to participate and started the study (100% recruitment of eligible SCD patients). Of the 6, 2 completed 10 treatments; 3 completed 8 or 9 treatments by the time the coronavirus disease 2019 (COVID-19) started, but had not missed any treatments and would have most likely completed if the study had not been halted, and completed all pre and post measures (83% retention). The 6th person could not complete because she was hospitalized, but probably would have completed otherwise.

Feasibility and acceptability were the only pre-specified outcome measures.
After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture
Time Frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

Protocol Acceptability Scale for Treating SCD with Acupuncture is a 10-item instrument with scores ranging from 0 to 20 used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study/did not like acupuncture/did not enjoy participating", and 2 means "liked the study/liked acupuncture/enjoyed participating". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 10 questions, divided the total score for the 10 questions by the maximum possible points for the measure, and converted the total mean scores to percentage of participants who liked the study/liked acupuncture/enjoyed participating.

Feasibility & acceptability were the specified outcome measures.
After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Judith M Schlaeger, PhD, UIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

March 15, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

November 1, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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