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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156399
Recruitment Status : Terminated (Due to the Coronavirus Disease 2019 (COVID-19) pandemic)
First Posted : November 7, 2019
Results First Posted : April 12, 2022
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Judith Schlaeger, University of Illinois at Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: Acupuncture Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study is an unblinded, uncontrolled trial.
Masking: None (Open Label)
Masking Description: There is no masking. This study is unblinded.
Primary Purpose: Basic Science
Official Title: Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study
Actual Study Start Date : January 15, 2020
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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Arm Intervention/treatment
Experimental: Acupuncture
All subjects will receive active acupuncture.
 Other: Acupuncture
All subjects will receive a standardized 18 needle acupuncture protocol.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156399


Locations
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United States, Illinois
University of Illinois at Chicago College of Nursing
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Judith M Schlaeger, PhD UIC
  Study Documents (Full-Text)

Documents provided by Judith Schlaeger, University of Illinois at Chicago:
Study Protocol and Statistical Analysis Plan  [PDF] November 12, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Judith Schlaeger, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04156399    
Other Study ID Numbers: 2019-1077
First Posted: November 7, 2019    Key Record Dates
Results First Posted: April 12, 2022
Last Update Posted: April 12, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judith Schlaeger, University of Illinois at Chicago:
sickle cell disease
pain
chronic pain
acupuncture
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn