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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04156399
• Other study ID #: 2019-1077
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: March 15, 2020

Study information

• Verified date: February 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• Acupuncture
All subjects will receive a standardized 18 needle acupuncture protocol.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago College of Nursing	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Primary	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.	After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)