Trial Outcomes & Findings for Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study (NCT NCT04156399)

Last Updated: 2022-04-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

Results posted on

2022-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Acupuncture All subjects will receive active acupuncture. Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol.
Overall Study STARTED	6
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Acupuncture All subjects will receive active acupuncture. Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol.
Overall Study hospitalization unrelated to acupuncture	1
Overall Study study suspension due to COVID pandemic	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupuncture n=6 Participants All subjects will receive active acupuncture. Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

Outcome measures

Outcome measures
Measure	Acupuncture n=5 Participants All subjects will receive active acupuncture. 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. Potential participants eligible	6 participants
Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD. Participants consented/started study	6 participants
Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD. Participants completed	5 participants
Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD. Participants not completed	1 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acupuncture n=5 Participants All subjects will receive active acupuncture. Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol.
Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture	16.4 score on a scale Standard Deviation 2.8

Adverse Events

Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Judith Schlaeger, PhD

University of Illinois Chicago

Phone: 3124134669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place