Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study
Phase: NA
Conditions: Sickle Cell Disease
Sponsor: University of Illinois at Chicago

 
 
 
 
Acupuncture for Adults with Sickle Cell Disease (SCD): A Feasibility Study 
                              
                                    Clinical Trials.gov Identifier: NCT04156399 
 
                         Principal Investigator: 
Judith Schlaeger, PhD, CNM, LAc, FAAN 
University of Illinois at Chicago, College of Nursing Department of Women, Children and 
Family Health Science 
 
Co-Investigators: 
Ardith Doorenbos, PhD, RN, University of Illinois at Chicago College of Nursing, 
Department of Biobehavioral Health Science 
Crystal Patil, PhD, University of Illinois at Chicago College of Nursing, Department of 
Women, Children and Family Health Science 
Alana Steffen, PhD, University of Illinois at Chicago College of Nursing, Department of 
Health Systems Science  
Robert Molokie, MD, University of Illinois at Chicago College of Medicine and College of 
Pharmacy 
Hongjin Li, PhD, University of Illinois at Chicago College of Nursing, Department of 
Biobehavioral Health Science 
 
Study Location(s):  
University of Illinois at Chicago College of Nursing  
845 S. Damen Avenue 
Chicago, IL 60612 
 
 
 

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TABLE OF CONTENTS 
Page 
Table of Contents ............................................................................................................ 2 
List of Abbreviations ........................................................................................................ 3 
1.0 Project Summary/Abstract ...................................................................................... 4 
2.0 Background/Scientific Rationale .............................................................................. 5 
3.0 Objectives/Aims .................................................................................................... 5 
4.0 Eligibility ................................................................................................................ 7 
4.1 Inclusion Criteria ............................................................................................. 7 
4.2 Exclusion Criteria ............................................................................................ 7 
 
5.0 Subject Enrollment................................................................................................ 7 
6.0 Study Design and Procedures ............................................................................. 6 
7.0 Expected Risks/Benefits ....................................................................................... 7 
8.0 Data Collection and Management Procedures ................................................... 7 
9.0 Data Analysis ......................................................................................................... 9 
10.0 Quality Control and Quality Assurance ............................................................... 9 
11.0 Data and Safety Monitoring .................................................................................. 9 
12.0 Statistical Considerations .................................................................................... 9 
13.0 Regulatory Requirements ..................................................................................... 9 
13.1 
Informed Consent ......................................................................................... 9 
13.2 
Subject Confidentiality .................................................................................. 9 
13.3 
Unanticipated Problems ............................................................................... 9 
14.0 References ............................................................................................................. 9 
Appendices ................................................................................................................. 132 
 

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LIST OF ABBREVIATIONS  
 
CON                        College of Nursing 
DMC  
 
Data Monitoring Committee 
DSMB  
 
Data and Safety Monitoring Board 
DSMP  
 
Data and Safety Monitoring Plan 
ICD 
 
 
Informed Consent Document 
IRB 
 
 
Institutional Review Board 
LAR  
 
Legally Authorized Representative 
OHRP  
 
Office of Human Research Protections 
OPRS  
 
Office for the Protection of Research Subjects 
PI 
 
 
Principal Investigator 
SAE  
 
Serious Adverse Event 
SCD                         Sickle Cell Disease  
SOP  
 
Standard Operating Procedure 
UIH                          University of Illinois Health 
 
 

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1.0 
Project Summary/Abstract 
Our 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. We 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, pain catastrophizing, and be interviewed about their feelings about 
receiving acupuncture. Subjects will also complete a measure of study acceptability, the 
Protocol Acceptability Scale for Treating SCD with Acupuncture at post-treatment. We will 
describe the procedures and potential challenges to implementing the acupuncture protocol and 
the range in the subjects’ Acceptability Scale scores. We expect to identify and rectify any 
procedural problems subjects will report regarding the 10-session study protocol.  
 

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2.0 
Background/Scientific Rationale  
Every 30 minutes, every day, a person dies from a prescription opioid overdose in the United 
States (US). Further, opioid use is associated with a myriad of adverse outcomes.1 Sickle cell 
disease (SCD) affects millions of people worldwide and is the most common lethal genetic blood 
disorder in the US, affecting about 100,000 people, mostly people of African and Hispanic 
background. Pain is the most common complication of SCD and is also a marker of clinical 
severity.2 People with SCD are a population living with a high burden of chronic pain, high 
prescription opioid use,3 and health care disparities.4 Many with SCD are treated long term with 
oral opioids and when hospitalized for acute pain are treated with parenteral opioids. 
 
Given this level of opioid use, it is crucial to consider complementary and integrative health 
(CIH) therapies as a method to decrease exposure to opioids while maintaining adequate pain 
control. One CIH therapy shown to be acceptable to people with SCD is acupuncture. 
Acupuncture typically involves inserting small needles into specific points on the body.1 It is 
shown to decrease pain and provide an alternative to opioid use.2-4 Importantly, it is now 
covered by Medicare and Medicaid and is thus widely available and no longer tied to 
socioeconomic disadvantage. If successful, our project will drastically improve clinic-based pain 
management and help to reduce reliance on opioids and prevent opioid use disorder.  
Acupuncture 
There are few studies of acupuncture for the treatment of SCD. Two were pediatric studies5 6 
and both reported pain reduction. A third study, which was an uncontrolled retrospective review, 
treated a total of 24 inpatient and outpatient adults during acute vaso-occlusive crisis with 
individualized acupuncture point prescriptions.7 Nine inpatients received a median of 3 
treatments and had a reduction in pain of 2.1 on a 0-10 pain rating scale. Fifteen outpatients 
received a median of 4 treatments and had up to a 75% reduction in pain. The fourth 
uncontrolled study treated 10 adults with a total of 16 acute vaso-occlusive crises; subjects 
reported a decrease in pain in 15 of 16 acute vaso-occlusive crises.8 Because there have been 
only two trials on using acupuncture for adults with SCD, it is important to generate data on 
feasibility, acceptability, and protocol revisions for a future fully powered RCT of a standardized 
acupuncture protocol. 
 
3.0 
Objectives/Aims 
          Aim: To determine the feasibility (recruitment, retention, completion) and acceptability of 
performing acupuncture on 15 adult subjects with SCD.  
 
Hypothesis: Acupuncture therapy will be feasible (80% recruitment, retention, 
completion) and acceptable to adults with SCD. 
 
Impact:  Acupuncture therapy has the potential to significantly reduce the pain and associated 
symptoms of SCD by offering therapy that is complimentary to optimal medical management. 
Symptom management is critical for reducing disability and improving quality of life for people 
with SCD. 
 
 
 
 

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4.0 
Eligibility 
• Adults with SCD who have had a moderate to severe level of pain (>3 on 0-10 
scale) related to SCD within the last 3 months, receiving care at the UI Health 
SCD clinic will be eligible to participate. 
 
4.1 Inclusion Criteria 
• Adults with SCD who have had a moderate to severe level of pain (>3 on 0-10 
scale) related to SCD within the last 3 months, receiving care at the UI Health 
SCD clinic will be eligible to participate. 
 
4.2 Exclusion Criteria 
• Pregnancy 
• Physically or cognitively unable to complete the study procedures 
 
5.0 
Subject Enrollment 
• The primary providers at the UI Health SCD clinic will determine if a patient is 
eligible for the study.  
• Eligibility will be assessed using the Eligibility Checklist. (See Appendix A for 
Eligibility Checklist). 
• The PI or other key research personnel will give out a flyer describing the 
study to each eligible patient during clinic visits, and explain the general 
aspects of the study. The flyer also has a contact number for potential 
subjects to use if interested.   
• Patients who express an interest in the study will meet with the PI or other 
key research personnel, who will explain the study in detail, answer 
questions, and obtain informed consent.  
• Upon consent, patients will be administered baseline study measures. 
 
6.0  Study Design and Procedures 
• This study is an unblinded, uncontrolled feasibility study.  
• All subjects will receive acupuncture. 
• Baseline measures will be taken prior to insertion of the acupuncture needles. 
• The research assistant will confirm the subject’s assigned code number 
before the start of each acupuncture session.  
• The subject will lay face up on the acupuncture exam table. 
• The acupuncturist will swab each of 18 acupuncture points with alcohol. 
• Needle insertion will then be performed with a tapping in technique. The 
needles will be retained for 30 minutes; they will be twirled 3 times throughout 
the treatment. The needles will then be pulled.  
• After the 10th acupuncture treatment the subject will complete data collection 
tools. 
 
 
 

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7.0 
Expected Risks/Benefits 
• Expected Risks: There is a risk of bruising or bleeding after the acupuncture 
needle is withdrawn. There is a risk that they may experience a negative reaction 
from acupuncture and thereby experience worse symptoms from participation in the 
study. If potential subjects are afraid of needles, they may not want to 
participate although the needles are very small. There is risk that some of the 
questions in the questionnaires may make the subject uncomfortable, 
nervous or tired. There is also the risk of loss of privacy or confidentiality, but 
we will avoid this and all other risks as much as possible. 
• Expected Benefits: There may be no benefit to individual subjects, but the 
knowledge gained from this study is expected to help providers better 
manage SCD pain by having a better understanding of whether or not 
acupuncture reduces the pain of SCD.  
 
 
8.0 
Data Collection and Management Procedures 
• All data will be collected on paper. All subjects will be assigned a code 
number and their data will be identified only with that code number. The link 
of the code numbers to the subject identifiers will be kept separate.  
• Data management and preliminary data analysis procedures will be                
supervised by the contact PI (JS). 
• The following measures will be completed by the subjects: 
 
 
Table: Acupuncture for Adults with Sickle Cell Disease Questionnaires 
Construct 
Operational Measure 
1 
2 Source* 
Demographic data 
Age, sex, race, employment status, comorbidities, marital status, number of 
household members, annual income, and educational attainment 
x 
 
S 
PROMIS 13  
Perceptions of pain intensity, global health,14 pain interference, depressive 
symptoms,15 anxiety,9,10 anger,15 sleep disturbance,17 fatigue,18 and self-
efficacy18,19 over the last 7 days, excellent validity across clinical contexts 
and high internal consistency across diverse racial-ethnic groups 
(Cronbach’s α= 0.92 – 0.96)20-23 
x 
x 
S 
McGill Pain Questionnaire 
(MPQ) 
 It also documents pain quality via 78 descriptors, and pain pattern via 9 
descriptors.24  The MPQ has demonstrated good reliability (α=.80).25 
x 
x 
S 
Pain catastrophizing24  
13-item scale; measures dimensions of the cognitive appraisal process of 
pain catastrophizing (magnification, rumination, helplessness); asked to 
indicate how much they experienced each item (thought/feeling).25,26 
x 
x 
S 
Injustice Experiences 
Questionnaire (IEQ-chr)27 
12-items;11 frequency rating for experiencing particular thoughts and 
feelings, such as “It all seems so unfair,” and “Nothing will ever make up for 
all that I have gone through.”28-32  
x 
 
S 
Credibility/Expectancy 
Questionnaire12 
6-items, feelings about acupuncture treatment expectancy and rationale 
credibility, test–retest 0.62-0.78, Cronbach’s α 0.84-0.85.12 
X  
S 
Protocol Acceptability Scale 
for Treating SCD with 
Acupuncture 
Assesses the acceptability of all study measures being completed and the 
study itself being completed. This scale will be measured after the last 
acupuncture session.33 
 
 
x 
S 
Cognitive interview  
9 question interview regarding subject’s feelings about receiving acupuncture 
x 
x 
I 
 
Source:  S = Self-report survey, I= Interview 
 
 
 

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9.0 
Data Analysis 
• 
Descriptive statistics will be conducted. Descriptive statistics (frequency, percentage, 
means, and standard deviations) were summarized at baseline. We reported pain 
intensity, pain interference and other pain related outcomes before and after the 
acupuncture intervention. 
 
10.0 Quality Control and Quality Assurance 
• 
The study is low risk; therefore, we do not anticipate any serious adverse 
events from the acupuncture intervention. The PI will provide oversight for the 
de-identification of the data.  The PI will review all data collection forms on an 
ongoing basis for: data completeness, data accuracy and protocol 
compliance.  
 
11.0 Data and Safety Monitoring 
• 
The study is low risk. However, the research team will monitor the safety 
of subjects during study procedures. In the event of injury related to this 
research, treatment will be available through the UIC Medical Center. 
However, the patient or third party payer, if any, will be responsible for 
payment of this treatment. Patient subjects will remain under the care of 
their usual provider, who will be available to give them usual care if 
needed.  Any unanticipated problems related to the study procedure will 
be immediately reported to the IRB. 
 
• 
Data Security: Each participant will be assigned a code number and 
their data will be identified only with that code number. Only the PI will 
have access to the code/master key. All questionnaires will be collected 
on paper and stored in a locked cabinet in the locked PI’s office. 
 
12.0 Statistical Considerations 
• This is a feasibility study and has not been powered. The data will be 
descriptive in nature.  
13.0 Regulatory Requirements 
13.1 Informed Consent              
• Informed consent will be obtained either by the PI or other key research 
personnel who have obtained IRB and HIPAA certifications. The RA will 
have been trained by the PI on the informed consent procedures. It will be 
obtained on paper. 
• The consent process will be completed in person and in a private area at 
either the UIH SCD Clinic or the acupuncture exam rooms on the 2nd floor 
CON.  

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• Subjects will be informed that they will receive 2 acupuncture treatments 
for 30 minutes each week for 5 weeks, for a total of 10 treatments.  
• Informed consent documents will be stored in a locked file cabinet in the 
locked PI’s office. The study team will have access to the informed 
consent documents. 
13.2 Subject Confidentiality  
• All measures will be completed in a private exam room with soundproof 
walls on the 2nd floor of the UIC CON. 
• The link between the research data and code number will be destroyed 
after all manuscripts are published. 
13.3 Unanticipated Problems 
• Any unanticipated problems related to the study procedure will be 
immediately reported to the IRB. 
 
14.0 References 
 
1.           Seth P, Rudd RA, Noonan RK, Haegerich TM. Quantifying the Epidemic of 
Prescription Opioid Overdose Deaths. Am J Public Health. 2018;108(4):500-502. 
2. 
Smith WR, Penberthy LT, Bovbjerg VE, et al. Daily assessment of pain in adults 
with sickle cell disease. Ann Intern Med. 2008;148(2):94-101. 
3. 
Smith WR, McClish DK, Dahman BA, et al. Daily home opioid use in adults with 
sickle cell disease: The PiSCES project. J Opioid Manag. 2015;11(3):243-253. 
4. 
Mathur VA, Kiley KB, Haywood C, Jr., et al. Multiple Levels of Suffering: 
Discrimination in Health-Care Settings is Associated With Enhanced Laboratory 
Pain Sensitivity in Sickle Cell Disease. The Clinical journal of pain. 
2016;32(12):1076-1085. 
5. 
Eshkevari L, Heath J. Use of acupuncture for chronic pain: optimizing clinical 
practice. Holist Nurs Pract. 2005;19(5):217-221. 
6. 
Zgierska AE, Burzinski CA, Cox J, et al. Mindfulness Meditation and Cognitive 
Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-
Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled 
Trial. Pain Med. 2016;17(10):1865-1881. 
7. 
Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture for Chronic Pain: Update 
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Zeidan F, Vago DR. Mindfulness meditation-based pain relief: a mechanistic 
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Bhushan D, Conner K, Ellen JM, Sibinga EM. Adjuvant acupuncture for youth 
with sickle cell pain: a proof of concept study. Med Acupunct. 2015;27(6):461-
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Tsai S-L, McDaniel D, Taromina K, Lee MT. Acupuncture for Sickle Cell Pain 
Management in a Pediatric Emergency Department, Hematology Clinic, and 
Inpatient Unit. Med Acupunct. 2015;27(6):510-514. 

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11. 
Lu K, Cheng MJ, Ge X, et al. A retrospective review of acupuncture use for the 
treatment of pain in sickle cell disease patients: descriptive analysis from a single 
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Co LL, Schmitz TH, Havdala H, Reyes A, Westerman MP. Acupuncture: an 
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13. 
Cook KF, Jensen SE, Schalet BD, et al. PROMIS measures of pain, fatigue, 
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14. 
Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical 
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Pilkonis PA, Choi SW, Reise SP, et al. Item banks for measuring emotional 
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Kroenke K, Yu Z, Wu J, Kean J, Monahan PO. Operating characteristics of 
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Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the 
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Amtmann D, Cook KF, Jensen MP, et al. Development of a PROMIS item bank 
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24.         Melzack R. The McGill Pain Questionnaire: major properties and scoring 
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Fishbain DA, Gao J, Lewis JE, Zhang L. At Completion of a Multidisciplinary 
Treatment Program, Are Psychophysical Variables Associated with a VAS 

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Improvement of 30% or More, a Minimal Clinically Important Difference, or an 
Absolute VAS Score Improvement of 1.5 cm or More? Pain Med. 
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Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development 
and validation. Psychol Assessment. 1995;7(4):524-532. 
27. 
Keefe FJ, Lipkus I, Lefebvre JC, et al. The social context of gastrointestinal 
cancer pain: a preliminary study examining the relation of patient pain 
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28. 
Badr H, Shen MJ. Pain catastrophizing, pain intensity, and dyadic adjustment 
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2014;30(11):923-933. 
29. 
Sullivan MJ, Adams H, Horan S, Maher D, Boland D, Gross R. The role of 
perceived injustice in the experience of chronic pain and disability: scale 
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30. 
Yakobov E, Scott W, Stanish W, Dunbar M, Richardson G, Sullivan M. The role 
of perceived injustice in the prediction of pain and function after total knee 
arthroplasty. Pain. 2014;155(10):2040-2046. 
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Sullivan MJ, Scott W, Trost Z. Perceived injustice: a risk factor for problematic 
pain outcomes. Clin J Pain. 2012;28(6):484-488. 
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McParland JL, Eccleston C. “It’s Not Fair” Social Justice Appraisals in the 
Context of Chronic Pain. Curr Dir Psychol Sci. 2013;22(6):484-489. 
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Sullivan MJ, Davidson N, Garfinkel B, Siriapaipant N, Scott W. Perceived 
injustice is associated with heightened pain behavior and disability in individuals 
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Sullivan MJ, Thibault P, Simmonds MJ, Milioto M, Cantin A-P, Velly AM. Pain, 
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APPENDICES  
 
 
APPENDIX A:  
Acupuncture for Adults with Sickle Cell Disease (SCD): A Feasibility Study  
Eligibility Checklist 
 
                                                                                                                       
                                                                                                                                                        Yes              No 
Inclusion criteria: 
• ≥18 years-old with a diagnosis of SCD    
                   
 
• Had a moderate to severe level of pain (>3 on 0-10 scale) related to SCD 
within the last 3 months  
                  
• Speaks/reads English   
 
• Receiving care at the UI Health SCD clinic 
 
Exclusion criteria: 
• Pregnant 
 
 
• Physically or cognitively unable to complete the study procedures 
 
 
 
 
 
 
 
 

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APPENDIX B, MEASURES: 
 
Demographic Measures 
 
 
 
 
 
 
 
 
 
 
 
 

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Qualitative Interview Guide Regarding Subject’s Feelings about Receiving 
Acupuncture 
 
1. What made you decide to join this study on acupuncture? 
a. Tell me about any past experiences you had with acupuncture  
b. Do others in your life use acupuncture?  
c. Not satisfied with your level of pain? 
                d. Heard acupuncture is used to treat pain. 
 
2. What were your expectations for getting acupuncture prior to participating in this study?  
 
3. Think about your overall acupuncture experience, how would you describe your 
experience?  
a. What do you think was happening in your body?  
b. Did you learn anything from the process of getting acupuncture? What did you 
learn? 
 
4. Describe how acupuncture affected your pain 
a. Did anything change about how you think about or relate to your pain after going 
through acupuncture treatments? 
 
5. Did anything about getting acupuncture surprise you?  
 
6. How is the acupuncture healthcare experience different from other healthcare 
experiences you have had?  
 
7. How did you feel about the acupuncturist?  
a. Did the acupuncturist treat any medical issues other than pain? What was that 
like?  
 
8. Tell me the reasons you would or would not continue to get acupuncture in the future.   
 
9. Is there anything else you would like us to know about how acupuncture affected you 
and your overall experience? 
 
 
 
 
 
 
 
 

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