Guided Relaxation + Acupuncture for Sickle Cell Disease

(GRACE Trial)

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

379 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will conduct a hybrid type 1 effectiveness implementation trial to assess the effectiveness of acupuncture and guided relaxation on 360 people with Sickle Cell Disease (SCD), while observing and gathering information on implementation in three health systems: University of Illinois Hospital \& Health Sciences System, University of Florida Health, and Duke University Health Systems. Each serves a large population with SCD, uses EPIC as their electronic health record, and has a Clinical and Translational Science Award (CTSA), which will help speed the translation of discovery into improved patient care. During the UH3 Implementation Phase, the 3-arm, 3-site randomized controlled trial will follow a quantitative modified SMART design, a pragmatic trial that evaluates adaptive interventions where the guided relaxation and acupuncture interventions respond to patients' characteristics and evolving pain status. The investigators rely on the Consolidated Framework for Implementation Research (CFIR) to plan, execute, and evaluate associated implementation processes. The use of complementary and integrative health (CIH) therapies by those with SCD to reduce pain and opioid use, to help enable them to better cope with their pain, is well known, but there are few studies that evaluate the effectiveness of these therapies, and none that also evaluates the implementation across multiple health care systems and patient populations as this study will. Aim 1: Determine the effectiveness of guided relaxation and acupuncture as compared to usual care in decreasing pain and opioid use for SCD patients. Hypothesis: At 6-weeks, SCD patients randomized to either CIH intervention will have a greater decrease in pain, opioid use, sleep, anxiety, depressive symptoms, and pain catastrophizing compared to SCD patients randomized to usual care. Aim 2: Identify the best adaptive intervention for improved outcomes by documenting outcomes among adaptive intervention sequences: (1) initiate guided relaxation and switch to acupuncture for non-responders at midpoint; (2) initiate guided relaxation and continue with guided relaxation for non-responders at midpoint; (3) initiate acupuncture and switch to guided relaxation for non-responders at midpoint or (4) initiate acupuncture and continue with acupuncture for non-responders at midpoint. Aim 3: Explore differences in response to the adaptive interventions by age and sex. Aim 4: Identify implementation facilitators, challenges, and solutions for structures and processes that contribute to the seamless integration of CIH therapies into the 3 health systems by conducting individual interviews with participants in the intervention group who responded to the intervention and those who did not. The investigators will also conduct focus groups with hospital personnel at 4 timepoints.

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.

What data supports the effectiveness of the treatment Guided Relaxation + Acupuncture for Sickle Cell Disease?

Research shows that acupuncture and guided relaxation are promising treatments for managing chronic pain in sickle cell disease. Patients and healthcare providers are open to these therapies, and acupuncture has been effective in some cases where other treatments failed. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Guided Relaxation + Acupuncture for Sickle Cell Disease?

Research shows that people with sickle cell disease are open to using acupuncture and guided relaxation for pain management, and some have found these therapies helpful. Additionally, acupuncture has been used effectively in some cases to relieve pain during sickle cell crises when other treatments failed. ^{1 2 3 4 5}

Is guided relaxation and acupuncture safe for humans?

Guided relaxation and acupuncture are generally considered safe for humans, with many people using them to manage pain, including those with sickle cell disease. However, it's important to consult with healthcare providers to ensure these therapies are appropriate for individual health needs. ^{1 2 3 5 6}

Is guided relaxation and acupuncture safe for humans?

Guided relaxation and acupuncture are generally considered safe for humans, with many people using them to manage pain, including those with sickle cell disease. However, it's important to consult with healthcare providers to ensure these therapies are appropriate for individual health conditions. ^{1 2 3 5 6}

How does the treatment of guided relaxation and acupuncture differ from other treatments for sickle cell disease?

This treatment is unique because it combines guided relaxation and acupuncture, which are non-drug therapies, to manage chronic pain in sickle cell disease. Unlike traditional pain management that often relies on opioids, this approach uses techniques that have shown promise in other pain conditions and are welcomed by patients and providers as complementary options. ^{1 2 3 4 7}

How does the treatment of guided relaxation and acupuncture differ from other treatments for sickle cell disease?

This treatment is unique because it combines guided relaxation and acupuncture, which are non-drug therapies, to manage chronic pain in sickle cell disease. Unlike traditional pain management that often relies on opioids, this approach uses techniques that focus on relaxation and specific points on the body to potentially reduce pain without the side effects associated with medications. ^{1 2 3 4 7}

Research Team

Ardith Doorenbos, PhD, RN, FAAN

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol. [2023]

2. United States 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. [2023]

3. Scotland pubmed.ncbi.nlm.nih.gov

Acupuncture for pediatric sickle cell pain management: A promising non-opioid therapy. [2020]

4. Singapore pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

The use and effectiveness of complementary and alternative medicine for pain in sickle cell anemia. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study. [2023]

7. Scotland pubmed.ncbi.nlm.nih.gov

Acupuncture for pain management in children with sickle cell disease. [2020]