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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 24 weeks

Awards & highlights

GRACE Trial 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.Check my eligibility

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.See study design

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.

GRACE Trial 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.

GRACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 24 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PROMIS Pain Interference

PROMIS Physical Function

Pain, Enjoyment of Life and General Activity scale (PEG)

Secondary outcome measures

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

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

GRACE 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH

832 Previous Clinical Trials

668,567 Total Patients Enrolled

University of Illinois at ChicagoLead Sponsor

608 Previous Clinical Trials

1,559,139 Total Patients Enrolled

University of FloridaOTHER

1,340 Previous Clinical Trials

715,339 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the Food and Drug Administration sanction Acupuncture as a viable treatment option?

"A risk assessment performed by Power gave acupuncture a score of two, reflecting the presence of some safety data but an absence of evidence for its efficacy."

Answered by AI

What is the purport of this project?

"The principal target of this trial, to be measured over 24 weeks from the baseline phase, is PROMIS Pain Interference. Supplementary outcomes include PROMIS Sleep Disturbance 8a (8-40 rating with higher scores signifying more severe sleep impairment), TAPS1 (Tobacco, Alcohol, Prescription medication and other Substance use; 1-20 scale with larger numbers suggesting frequent substance consumption in the last 12 months) and Sleep Duration (quantity of hours slept)."

Answered by AI

How many participants are involved in the current clinical trial?

"Correct. According to the clinicaltrials.gov, this trial is still enrolling patients as of September 23rd 2022, with a total of 366 participants sought from 3 different medical centres since its initial launch on November 24th 2021."

Answered by AI

Is recruitment still open for this experiment?

"Affirmative. Information on clinicaltrials.gov affirms that this experiment began recruiting participants on November 24th 2021, and is still actively searching for volunteers as of September 23rd 2022. A total of 366 patients are needed across 3 medical study locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain

Ardith Doorenbos 2021. "Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04906447.

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