Guided Relaxation + Acupuncture for Sickle Cell Disease
(GRACE Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: University of Illinois at Chicago
Disqualifiers: Stem cell transplant, Incarceration, others
No Placebo Group
Prior Safety Data
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.
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.
12345Is 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.
12356How 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.
12347Eligibility 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.
+2 more
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.
+1 more
Participant Groups
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.
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
Acupuncture is already approved in United States, European Union, China, Australia 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
🇦🇺 Approved in Australia as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins UniversityBaltimore, MD
Emory UniversityAtlanta, GA
University of FloridaGainesville, FL
University of Illinois at ChicagoChicago, IL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
University of FloridaCollaborator
Duke UniversityCollaborator
References
Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol. [2023]People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems.
Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain. [2023]Objective: This study aimed to explore perspectives of people living with sickle cell disease (SCD) and SCD clinic providers and staff about the use of acupuncture and guided relaxation for treating chronic SCD pain. Data obtained were to inform an implementation blueprint for an effectiveness implementation clinical trial (GRACE Trial) testing whether acupuncture or guided relaxation reduces chronic pain when compared with usual care. Design: Qualitative research design. Methods: We conducted 33 semistructured interviews with people with SCD and SCD clinic providers and staff. Interviews were transcribed and coded. A deductive content analysis process was used to identify themes. Results: Four themes were identified: Receptivity to Acupuncture and Guided Relaxation, Limited Awareness, Complementary and Integrative Health (CIH) Therapy Preference, and Access Barriers. Both patients and clinic providers and staff were open to the use of acupuncture and guided relaxation for chronic pain treatment. After learning about these CIH therapies, some patients expressed a preference for one therapy over the other. They also discussed their ability to successfully engage with each therapy. There is a need to dispel misconceptions about the therapies by increasing understanding of how each therapy is implemented and functions to reduce pain. We identified several potential barriers that might affect the success of the trial and future health system integration, including time, transportation, and technology. Conclusion: This study is one of the first to present perspectives of both patients with SCD and clinic providers and staff on the use of acupuncture and guided relaxation for chronic SCD pain. Stakeholders' early input and perspectives highlighted that they welcome nonpharmacological CIH therapies. Implementation of a clinical trial and future health system integration will require the addressing misinformation and identifying strategies to overcome access barriers. Clinical trial registration number: NCT04906447.
Acupuncture for pediatric sickle cell pain management: A promising non-opioid therapy. [2020]To describe the use of acupuncture for pain management in children with sickle cell disease.
Acupuncture and blood studies in sickle-cell anemia. [2006]The author recently treated a case of sickle-cell crisis as an emergency for pain relief using acupuncture because all other conventional therapies failed. The result was so effective, dramatic and encouraging that four other cases of genotype SS/SC were also treated. These cases are reported, (though small in number) to bring attention to this easy, simple, cheap and convenient therapy and to stimulate research among practicing acupuncturists and clinicians.
The use and effectiveness of complementary and alternative medicine for pain in sickle cell anemia. [2022]Pain is the clinical hallmark for sickle cell disease (SCD). The objective of this study was to survey the extent and effectiveness of complementary and alternative medicine (CAM) use for pain control among adults with SCD. Of a total of 227 African-American adults with SCD, 208 (92%) admitted to using at least one type of CAM. The three most common types of CAM were prayer (61%), relaxation technique (44%), and massage (35%). Multiple logistic regression showed that marital status was associated with use of relaxation techniques (p = 0.044), and age between 18 and 24 years and at least a high school level of education were associated with use of prayer (p = 0.008 and p = 0.004 respectively). Our study showed that CAM use is common among adult patients with SCD. Further well designed prospective studies are needed to help develop best practices that emphasize an optimized balance of conventional and evidence based CAM therapies.
Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study. [2023]Chronic pain is a common symptom experienced among patients with sickle cell disease (SCD). Our aims were to assess the feasibility and acceptability of performing acupuncture for the treatment of chronic pain in adults with SCD.
Acupuncture for pain management in children with sickle cell disease. [2020]Pain associated with sickle cell disease (SCD) is frequently treated with opioids which have many side effects. There is a need for adjuvant non-opioid therapies that can improve pain control. Acupuncture, an integrative approach, has been shown to be useful in non-SCD pain conditions but has been used to a very limited extent in SCD. In this report we present a single academic pediatric center experience showing acceptability, feasibility and improved pain experience with adjuvant acupuncture therapy in children with SCD and suggest that acupuncture should be explored as a treatment option for managing pain in SCD.