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

NCT04156399 | Terminated Results

• 1 other identifier: 2019-1077
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; pain; chronic pain; acupuncture

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (1)

Acupuncture

EXPERIMENTAL

All subjects will receive active acupuncture.

Other: Acupuncture

Interventions

Acupuncture OTHER

All subjects will receive a standardized 18 needle acupuncture protocol.

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Physically or cognitively unable to complete the study procedures

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago College of Nursing

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Li H, Patil CL, Molokie RE, Njoku F, Steffen AD, Doorenbos AZ, Schlaeger JM. Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study. Acupunct Med. 2021 Dec;39(6):612-618. doi: 10.1177/09645284211017303. Epub 2021 Jun 3.

  PMID: 34080441 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain; Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

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.

Results Point of Contact

• Title: Judith Schlaeger, PhD
• Organization: University of Illinois Chicago

jschlaeg@uic.edu

3124134669

Study Officials

• Judith M Schlaeger, PhD

  UIC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There is no masking. This study is unblinded.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is an unblinded, uncontrolled trial.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 7, 2019
• Study Start: January 15, 2020
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)