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

Overview

The investigators long-term goal is to demonstrate the effectiveness of acupuncture for the treatment of adults with chronic pain of 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 sickle cell patients. 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. 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 subjects will report regarding the 10-session study protocol.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 15, 2020

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Acupuncture
    • All subjects will receive active acupuncture.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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 on 0-10 scale) within the last 3 months

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Illinois at Chicago
  • Provider of Information About this Clinical Study
    • Principal Investigator: Judith Schlaeger, Assistant Professor – University of Illinois at Chicago
  • Overall Official(s)
    • Judith M Schlaeger, PhD, Principal Investigator, UIC
  • Overall Contact(s)
    • Judith M Schlaeger, PhD, 3124134669, jschlaeg@uic.edu

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