Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study
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|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
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Other: Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|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|
All subjects will receive active acupuncture.
All subjects will receive a standardized 18 needle acupuncture protocol.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Physically or cognitively unable to complete the study procedures
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
|United States, Illinois|
|University of Illinois at Chicago College of Nursing|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Judith M Schlaeger, PhD||UIC|
Documents provided by Judith Schlaeger, University of Illinois at Chicago:
|Responsible Party:||Judith Schlaeger, Assistant Professor, University of Illinois at Chicago|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
sickle cell disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn