Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156399
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Judith Schlaeger, University of Illinois at Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: Acupuncture Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Official Title: Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture
All subjects will receive active acupuncture.
Other: Acupuncture
All subjects will receive a standardized 18 needle acupuncture protocol.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 on 0-10 scale) within the last 3 months

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156399


Contacts
Layout table for location contacts
Contact: Judith M Schlaeger, PhD 3124134669 jschlaeg@uic.edu
Contact: Ardith Z Doorenbos, PhD 3129962817 ardith@uic.edu

Locations
Layout table for location information
United States, Illinois
University of Illinois at Chicago College of Nursing Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Judith M Schlaeger, PhD    708-334-1097    jschlaeg@uic.edu   
Contact: Ardith Z Doorenbos, PhD    3129962817    ardith@uic.edu   
Principal Investigator: Judith M Schlaeger, PhD         
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Layout table for investigator information
Principal Investigator: Judith M Schlaeger, PhD UIC

Layout table for additonal information
Responsible Party: Judith Schlaeger, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04156399     History of Changes
Other Study ID Numbers: 2019-1077
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judith Schlaeger, University of Illinois at Chicago:
sickle cell disease
pain
chronic pain
acupuncture
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn