Guided Relaxation + Acupuncture for Sickle Cell Disease

(GRACE Trial)

Not currently recruiting at 4 trial locations

Overseen By Victoria deMartelly, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Illinois at Chicago

Disqualifiers: Stem cell transplant, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how acupuncture and guided relaxation can help individuals with Sickle Cell Disease (SCD) manage pain and reduce opioid use. The study will compare these treatments to usual care to assess their effects on pain, sleep, anxiety, and depression. Participants will join one of three groups: usual care, acupuncture, or guided relaxation. The trial seeks individuals diagnosed with SCD who experience chronic pain impacting daily activities. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adding guided relaxation and acupuncture to your care, so you may not need to stop your current treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adding guided relaxation and acupuncture to your care, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that acupuncture is generally safe and effective for relieving pain, even in children. One study found that acupuncture reduced pain in people with sickle cell disease without any safety issues. Another study demonstrated that acupuncture did not cause harmful effects, even in individuals with low platelet counts.

Research indicates that guided relaxation is easy to perform and well-accepted by people with sickle cell disease, as they generally find it simple and experience no negative effects. The American Society of Hematology recommends guided relaxation for treating sudden pain in both adults and children.

Overall, both acupuncture and guided relaxation appear well-tolerated, with no major safety concerns reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for sickle cell disease because they offer non-drug alternatives that could complement or enhance current care options. Acupuncture is unique because it involves stimulating specific points on the body to potentially relieve pain and improve blood flow, which could help manage the chronic pain associated with sickle cell disease. Guided relaxation, on the other hand, uses a daily app to reduce stress and anxiety, which are common in patients and can worsen symptoms. Both treatments focus on holistic well-being and could provide relief without the side effects often seen with medications.

What evidence suggests that this trial's treatments could be effective for Sickle Cell Disease?

Research has shown that acupuncture, one of the treatments studied in this trial, can help reduce pain for people with Sickle Cell Disease (SCD). Studies suggest that acupuncture might decrease inflammation, which is linked to less pain. People with SCD have responded well to acupuncture and reported feeling less pain after treatment.

Guided relaxation, another treatment option in this trial, also shows promise for managing pain in SCD. Some studies indicate it can help lower pain, reduce anxiety, and decrease the need for pain medications like opioids. Both acupuncture and guided relaxation offer non-drug options that could enhance the quality of life for people with SCD. ^{2 3 6 7 8}

Who Is on the Research Team?

Ardith Doorenbos, PhD, RN, FAAN

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My pain affects my daily activities with a score of 3 or more.

Provision of signed and dated informed consent form

I have been diagnosed with sickle cell disease.

Exclusion Criteria

Any other condition that the investigator considers precludes participation in the clinical trial

Current incarceration

I have had a stem cell transplant for sickle cell disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either acupuncture treatments twice a week for five weeks or daily use of a guided relaxation app for 6 weeks

6 weeks

Acupuncture: 10 visits (in-person), Guided Relaxation: Daily use (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture
• Guided Relaxation

Trial Overview 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.

How Is the Trial Designed?

Group I: Guided Relaxation Experimental Treatment 1 Intervention

Daily use of a guided relaxation app for 6 weeks

Group II: Acupuncture Experimental Treatment 1 Intervention

Acupuncture treatments twice a week for five weeks

Group III: Control arm Active Control 1 Intervention

Participants randomized to the control arm will receive usual care

Acupuncture is already approved in United States, European Union, China for the following indications:

Approved in United States as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Approved in European Union as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Acupuncture was successfully used to relieve pain in a patient experiencing a sickle-cell crisis when conventional treatments failed, demonstrating its potential as an effective alternative therapy.

Following the initial success, four additional patients with sickle-cell genotype SS/SC were treated with acupuncture, suggesting that this method could be a simple and cost-effective option for managing pain in similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture and blood studies in sickle-cell anemia. Sodipo, J.[2006]

Acupuncture has been found to be an acceptable and feasible adjuvant therapy for managing pain in children with sickle cell disease (SCD), which is often treated with opioids that have significant side effects.

The use of acupuncture showed an improved pain experience for these children, suggesting it could be a valuable non-opioid treatment option for SCD pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for pain management in children with sickle cell disease. Mahmood, LA., Reece-Stremtan, S., Idiokitas, R., et al.[2020]

Patients with sickle cell disease (SCD) and clinic providers are generally receptive to using acupuncture and guided relaxation as treatments for chronic pain, indicating a potential interest in nonpharmacological therapies.

Barriers such as limited awareness, misconceptions about the therapies, and access issues (like time and transportation) need to be addressed to successfully implement these therapies in clinical practice and future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain. Knisely, MR., Rivera, E., deMartelly, VA., et al.[2023]

The GRACE study is evaluating the effectiveness of guided relaxation and acupuncture for managing chronic pain in sickle cell disease, involving 366 participants randomized into two intervention groups or usual care over a 24-week period.

The primary focus is on measuring changes in pain impact scores, along with secondary outcomes like opioid use and mental health factors, to determine the best treatment approach tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol. Doorenbos, AZ., Schlaeger, JM., deMartelly, VA., et al.[2023]

A significant 92% of 227 surveyed African-American adults with sickle cell disease reported using complementary and alternative medicine (CAM) for pain management, with prayer, relaxation techniques, and massage being the most common methods.

The study highlights the need for further research to establish best practices that integrate conventional treatments with evidence-based CAM therapies for better pain control in sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use and effectiveness of complementary and alternative medicine for pain in sickle cell anemia. Majumdar, S., Thompson, W., Ahmad, N., et al.[2022]

A retrospective review of 90 acupuncture treatments in 24 pediatric patients with sickle cell disease showed that acupuncture effectively reduced pain in 65.5% of cases, with significant reductions in pain scores on a 0-4 scale (p < 0.0001).

The study found no adverse events associated with acupuncture, highlighting it as a safe non-opioid option for pain management in children with sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for pediatric sickle cell pain management: A promising non-opioid therapy. Tsai, SL., Bombacie, M., Licursi, M., et al.[2020]

A pilot study involving six adults with sickle cell disease showed that acupuncture is feasible and acceptable for treating chronic pain, with high completion rates and no reported adverse events.

Participants experienced reduced pain intensity and interference after the acupuncture sessions, and the protocol received a high acceptability score of 82%, suggesting it could be a promising option for pain management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study. Li, H., Patil, CL., Molokie, RE., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37905075/

Differential clinical characteristics across traditional ... According to the literature, acupuncture has shown certain therapeutic effects for pain management in SCD. However, these clinical studies lack ...

2. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/2519/532868/Acupuncture-Ameliorates-Heightened-Inflammatory

Acupuncture Ameliorates Heightened Inflammatory/Immune ... Our preliminary results suggest that acupuncture treatment is effective in reducing proinflammatory/immuneresponses that is associated with improved pain and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0965229919306727

Acupuncture for pain management in children with sickle ... Acupuncture therapy was well tolerated and was associated with reduction in pain scores. •. Acupuncture may be useful as an adjuvant modality for pain control ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04122378

NCT04122378 | Acupuncture for Pain in Sickle Cell Disease Acupuncture therapy is a non-pharmacological Chinese medicine approach which has been used in many non-SCD conditions associated with pain. Proposed study ...

5. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2023.1233293/full

Differential clinical characteristics across traditional ... According to the literature, acupuncture has shown certain therapeutic effects for pain management in SCD. However, these clinical studies lack the guidance of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9324601/

Acupuncture for Pain Management in Pediatric Patients with ... Acupuncture is recognized by the NIH as generally safe and effective for pain, and acupuncture appears to be a promising therapy for pediatric ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0965229919308386

Acupuncture for pediatric sickle cell pain management Conclusion. Acupuncture therapy decreased pain for our patients with sickle cell disease, providing a safe non-opioid therapeutic option.

8. publications.aap.org publications.aap.org/pediatrics/article/147/3_MeetingAbstract/290/5137/Safety-And-Acceptance-Of-Acupuncture-And

Safety And Acceptance Of Acupuncture And Acupressure ... There were no adverse effects or safety concerns noted, despite the presence of thrombocytopenia that is typical immediately following HSCT.