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

• ClinicalTrials.gov Identifier: NCT04156399
• Recruitment Status: Terminated
• First Posted: November 7, 2019
• Results First Posted: April 12, 2022
• Last Update Posted: April 12, 2022
• Sponsor: University of Illinois at Chicago
• Information provided by (Responsible Party): Judith Schlaeger, University of Illinois at Chicago

Tracking Information

• First Submitted Date: November 1, 2019
• First Posted Date: November 7, 2019
• Results First Submitted Date: March 9, 2021
• Results First Posted Date: April 12, 2022
• Last Update Posted Date: April 12, 2022
• Actual Study Start Date: January 15, 2020
• Actual Primary Completion Date: March 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 22, 2022)

• 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.

Original Primary Outcome Measures (submitted: November 6, 2019)

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale [ Time Frame: through study completion, an average of 5 weeks ]

Measures change in pain intensity from 0, no pain to 5, very severe. Higher scores indicate worse outcome.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: November 6, 2019)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in overall health from 5, excellent to 1, poor. Higher scores indicate worse outcomes.
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in the amount that pain interferes with life from 1, not at all to 5, very bad. Higher scores indicate worse outcomes.
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in depression from 1, never to 5, always. Higher scores indicate worse outcomes.
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in anxiety from 1, never to 5, always. Higher scores indicate worse outcomes.
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anger [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in anger from 1, never to 5, always. Higher scores indicate worse outcomes.
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in sleep disturbance from 5, not at all to 1, very much. Higher scores indicate worse outcomes.
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Form [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in fatigue from 1, not at all to 5, always. Higher scores represent worse outcomes.
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy-Short Form [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in the level of confidence in managing various situations, problems, and events from 1, not at to 5, always. Higher scores represent worse outcomes.
• Change in Injustice Experience Questionnaire [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in thoughts and feelings you may experience when you think about your pain from 0, never to 4, all the time. Higher scores represent worse outcomes.
• Change in Pain Catastrophization Questionnaire [ Time Frame: through study completion, an average of 5 weeks ]
  Measures change in the type of thoughts and feelings that you experience when you are in pain from 0, not at all to 4, all the time. Higher scores represent worse outcomes.
• Qualitative Interview Guide Regarding Subject's Feelings about Receiving Acupuncture [ Time Frame: through study completion, an average of 5 weeks ]
  Open-ended responses regarding receiving acupuncture
• Protocol Acceptability Scale for Treating Sickle Cell Disease with Acupuncture [ Time Frame: through study completion, an average of 5 weeks ]
  Measures acceptability of the acupuncture protocol with 1, not hard, easy, not rushed, enjoyed, I liked it, not painful, I would get it again, others will enjoy, too short; to 3, too hard, did not enjoy, I didn't like, it was painful, I would not get again, others did not enjoy, too long. Higher scores indicate worse outcomes.

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: November 6, 2019)

Change in McGill Pain Questionnaire [ Time Frame: through study completion, an average of 5 weeks ]

Measures change in pain intensity from 0, no pain to 10, pain as bad as it could be.

Descriptive Information

• Brief Title: Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study
• Official Title: Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study
• 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
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

• Condition: Sickle Cell Disease

Intervention

Other: Acupuncture

All subjects will receive a standardized 18 needle acupuncture protocol.

Study Arms

Experimental: Acupuncture

All subjects will receive active acupuncture.

Intervention: Other: Acupuncture

• Publications *: 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 12, 2020): 6
• Original Estimated Enrollment (submitted: November 6, 2019): 15
• Actual Study Completion Date: March 15, 2020
• Actual Primary Completion Date: March 15, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04156399
• Other Study ID Numbers: 2019-1077
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Judith Schlaeger, University of Illinois at Chicago
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Illinois at Chicago
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Judith M Schlaeger, PhD; UIC

• PRS Account: University of Illinois at Chicago
• Verification Date: February 2022