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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Sickle Cell Disease
Intervention Other: Acupuncture
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acupuncture
Hide Arm/Group Description

All subjects will receive active acupuncture.

Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol.
Period Title: Overall Study
Started 6
Completed 2 [1]
Not Completed 4
Reason Not Completed
hospitalization unrelated to acupuncture             1
study suspension due to COVID pandemic             3
[1]
Of the six participants who started the study, two completed all 10 acupuncture sessions, two completed 9 sessions, and one completed 8 sessions. The three who completed 8 or 9 sessions were unable to complete due to the COVID-19 lockdowns, however, we were able to collect post-test measures for them. Finally, one participant was hospitalized (unrelated to acupuncture) and could not complete the study nor provide post-test measures.
Arm/Group Title Acupuncture
Hide Arm/Group Description

All subjects will receive active acupuncture.

Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
6
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD.
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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)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acupuncture
Hide Arm/Group Description:

All subjects will receive active acupuncture.

Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Potential participants eligible 6
Participants consented/started study 6
Participants completed 5
Participants not completed 1
2.Primary Outcome
Title Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture
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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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acupuncture
Hide Arm/Group Description:

All subjects will receive active acupuncture.

Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
16.4  (2.8)
Time Frame 5 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acupuncture
Hide Arm/Group Description

All subjects will receive active acupuncture.

Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol.
All-Cause Mortality
Acupuncture
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Serious Adverse Events
Acupuncture
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acupuncture
Affected / at Risk (%)
Total   0/6 (0.00%) 
A limitation of the study is that it had to be terminated early due to COVID-19 lockdowns, resulting in only 6 recruited and 5 participants analyzed. Another limitation is the inability to complete all acupuncture sessions on 3 participants due to the pandemic. In addition, the one-armed design reduced the ability to test significant changes in measures (pain intensity, pain interference, fatigue, sleep disturbance, depression, anxiety, and anger) before and after the acupuncture intervention.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Judith Schlaeger, PhD
Organization: University of Illinois Chicago
Phone: 3124134669
EMail: jschlaeg@uic.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Judith Schlaeger, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04156399    
Other Study ID Numbers: 2019-1077
First Submitted: November 1, 2019
First Posted: November 7, 2019
Results First Submitted: March 9, 2021
Results First Posted: April 12, 2022
Last Update Posted: April 12, 2022