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

Primary Purpose

Sickle Cell Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sickle Cell Disease focused on measuring sickle cell disease, pain, chronic pain, acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Chicago College of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture

Arm Description

All subjects will receive active acupuncture.

Outcomes

Primary Outcome Measures

Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD.
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.
Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture
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.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2019
Last Updated
February 22, 2022
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04156399
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to the Coronavirus Disease 2019 (COVID-19) pandemic
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
sickle cell disease, pain, chronic pain, acupuncture

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is an unblinded, uncontrolled trial.
Masking
None (Open Label)
Masking Description
There is no masking. This study is unblinded.
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
All subjects will receive active acupuncture.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
All subjects will receive a standardized 18 needle acupuncture protocol.
Primary Outcome Measure Information:
Title
Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD.
Description
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.
Time Frame
After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Title
Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture
Description
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.
Time Frame
After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith M Schlaeger, PhD
Organizational Affiliation
UIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago College of Nursing
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34080441
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.
Results Reference
derived

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

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