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Guided Relaxation + Acupuncture for Sickle Cell Disease (GRACE Trial)

Phase 2
Recruiting
Led By Ardith Doorenbos, PhD, RN, FAAN
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current pain interference using the general activity question from PEG, score ≥3 on 0-10 scale
Diagnosis of sickle cell disease based on hemoglobin electrophoresis
Must not have
Has had a stem cell transplant for sickle cell disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effectiveness of acupuncture and guided relaxation on 360 people with Sickle Cell Disease, while also observing implementation in three health systems.

Who is the study for?
This trial is for people with Sickle Cell Disease who experience chronic pain most days or every day. Participants must have a confirmed diagnosis, speak English, and consent to join the study. They should also feel that pain affects their daily activities (score ≥3 on a scale of 0-10). People who've had stem cell transplants, severe opioid disorders, are incarcerated, or on chronic transfusion programs cannot join.
What is being tested?
The trial tests if guided relaxation and acupuncture can reduce pain and opioid use in SCD patients compared to usual care. It's an adaptive study across three health systems where treatments may switch based on patient response at the midpoint. The effectiveness and how well these therapies integrate into healthcare will be studied.
What are the potential side effects?
While not explicitly stated in the provided information, common side effects of acupuncture could include soreness, minor bleeding or bruising at needle sites; guided relaxation typically has minimal risk but may include discomfort with new techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pain affects my daily activities with a score of 3 or more.
Select...
I have been diagnosed with sickle cell disease.
Select...
I have experienced pain on some, most, or every day in the past 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a stem cell transplant for sickle cell disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PROMIS Pain Interference
PROMIS Physical Function
Pain, Enjoyment of Life and General Activity scale (PEG)
Secondary study objectives
Gastrointestinal Constipation 9a
Generalised Anxiety Disorder Questionnaire (GAD-7)
PROMIS sleep disturbance 8a
+5 more

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811
2%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Guided RelaxationExperimental Treatment1 Intervention
Daily use of a guided relaxation app for 6 weeks
Group II: AcupunctureExperimental Treatment1 Intervention
Acupuncture treatments twice a week for five weeks
Group III: Control armActive Control1 Intervention
Participants randomized to the control arm will receive usual care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guided Relaxation
2008
N/A
~20

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
866 Previous Clinical Trials
674,470 Total Patients Enrolled
University of Illinois at ChicagoLead Sponsor
640 Previous Clinical Trials
1,568,423 Total Patients Enrolled
University of FloridaOTHER
1,409 Previous Clinical Trials
767,187 Total Patients Enrolled
Duke UniversityOTHER
2,462 Previous Clinical Trials
2,968,554 Total Patients Enrolled
Ardith Doorenbos, PhD, RN, FAANPrincipal InvestigatorUniversity of Illinois at Chicago

Media Library

Acupuncture Clinical Trial Eligibility Overview. Trial Name: NCT04906447 — Phase 2
Sickle Cell Disease Research Study Groups: Control arm, Acupuncture, Guided Relaxation
Sickle Cell Disease Clinical Trial 2023: Acupuncture Highlights & Side Effects. Trial Name: NCT04906447 — Phase 2
Acupuncture 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906447 — Phase 2
~44 spots leftby Jun 2025
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