Acupressure for Sickle Cell Disease

Recruiting at 1 trial location

Overseen By Ying Wang, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Autoimmune, Inflammatory, Psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

240 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires you to limit your current medications for pain control during the study visits, but it doesn't specify if you need to stop them completely. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Acupressure for Sickle Cell Disease?

Research shows that non-drug approaches like deep tissue massage and acupressure can help relieve pain and improve the quality of life for people with sickle cell disease. Additionally, many patients with sickle cell disease use complementary therapies like massage to manage pain, indicating potential benefits. ^{1 2 3 4 5}

Is acupressure safe for humans?

Research shows that acupressure is generally safe and well-tolerated, with no treatment-related adverse events reported in studies involving adults on hemodialysis and children undergoing medical procedures. Reflexology, a form of acupressure, is also considered safe with no side effects, although massage therapies can have rare risks like soft tissue trauma or spinal issues, especially with spinal manipulation. ^{6 7 8 9 10}

How does acupressure treatment differ from other treatments for sickle cell disease?

Acupressure for sickle cell disease is unique because it is a non-drug approach that uses pressure on specific points of the body to relieve pain and improve quality of life, unlike traditional treatments that often rely on medications like opioids. ^{1 3 4 5 11}

What is the purpose of this trial?

The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupressure analgesia in patients with sickle cell disease (SCD).

Eligibility Criteria

This trial is for adolescents and adults aged 14-80 with Sickle Cell Disease who have had chronic pain or a vaso-occlusive crisis in the past year. Participants must speak English, give consent, limit other pain treatments during the study, and commit to bi-daily acupressure sessions for 5 weeks.

Inclusion Criteria

I am between 14 and 80 years old.

I am willing to limit my pain medications during the study.

Fluent in English and capable of giving written informed consent

Exclusion Criteria

I have had a head injury that caused me to lose consciousness significantly.

I do not have severe psychiatric conditions like schizophrenia or major depression with suicidal thoughts.

I have used acupuncture or similar methods for pain management in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote self-administered acupressure treatment every other day

5 weeks

Remote self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain, sleep quality, and quality of life

6 months

Remote follow-up visits

Treatment Details

Interventions

• Acupressure 1
• Acupressure 2

Trial Overview The study tests the effectiveness of acupressure analgesia on patients with Sickle Cell Disease. It involves two types of acupressure techniques to understand how they relieve pain and their underlying neurological mechanisms.

Participant Groups

Group I: Usual Care + Acupressure Experimental Treatment 1 Intervention

Participants will continue ongoing usual care and administer self-acupressure treatment.

Group II: Usual Care Only Active Control 1 Intervention

Acupressure 1 is already approved in China, United States for the following indications:

Approved in China as Acupressure for:

• Pain management
• Osteoarthritis

Approved in United States as Acupressure for:

• Pain management
• Sickle cell disease

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Findings from Research

A non-pharmacologic approach using deep tissue and deep pressure massage therapy, along with neuromuscular trigger point treatment and acupressure, significantly alleviates pain in patients with sickle cell disease (SCD).

This therapy not only helps reduce pain but also improves the overall quality of life for individuals suffering from SCD, which is crucial given the chronic pain and associated issues like depression and disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacologic management of sickle cell pain. Bodhise, PB., Dejoie, M., Brandon, Z., et al.[2011]

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]

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]

Healing Touch therapy showed a greater reduction in present pain for hospitalized adults with sickle cell disease compared to the Attention Control group, particularly on Day 1, although the overall sample size was small and results were not statistically significant across all measures.

Both groups experienced reductions in anxiety and stress, with the Healing Touch group showing significant stress reduction after Days 2 and 4, suggesting potential benefits of Healing Touch for managing stress in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study: the effect of healing touch on anxiety, stress, pain, pain medication usage, and physiological measures in hospitalized sickle cell disease adults experiencing a vaso-occlusive pain episode. Thomas, LS., Stephenson, N., Swanson, M., et al.[2013]

Parents of children undergoing hematopoietic cell transplantation reported that massage and acupressure provided significant relief from pain and nausea, as well as improved relaxation and sleep for their children.

The study highlighted that parents felt more competent and connected to their children through the practice of massage/acupressure, suggesting that this intervention not only benefits the child but also enhances the caregiver's experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage for children undergoing hematopoietic cell transplantation: a qualitative report. Ackerman, SL., Lown, EA., Dvorak, CC., et al.[2023]

A review of 40 reports from 2003 to 2013 identified 138 adverse events (AEs) related to pain-related massage, highlighting that while serious complications like disc herniation and spinal cord injury can occur, the overall incidence of these events is low.

The findings suggest that although massage therapies carry some risks, particularly with spinal manipulation, they are generally considered safe when performed by qualified practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of massage therapy in pain-related conditions: a systematic review. Yin, P., Gao, N., Wu, J., et al.[2022]

The study involved 56 interviews with health professionals in Canada, revealing a significant disagreement about the actual risks associated with spinal manipulation therapy (SMT), indicating a need for clearer communication and understanding of safety issues.

Participants identified barriers to implementing an incident reporting system for SMT, suggesting that collaboration among different health professions is essential to improve patient safety and learn from adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring approaches to patient safety: the case of spinal manipulation therapy. Rozmovits, L., Mior, S., Boon, H.[2022]

In a study involving 42 patients undergoing hemodialysis, real acupressure did not show a significant improvement in sleep quality compared to sham acupressure, indicating uncertain therapeutic efficacy.

Despite the lack of efficacy in improving sleep quality, acupressure was found to be safe, well-tolerated, and favorably accepted by participants, suggesting it could be a complementary therapy for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SIESTA Trial: A Randomized Study Investigating the Efficacy, Safety, and Tolerability of Acupressure versus Sham Therapy for Improving Sleep Quality in Patients with End-Stage Kidney Disease on Hemodialysis. Shen, K., Cho, Y., Pascoe, EM., et al.[2020]

Reflexology is a safe treatment that promotes homeostasis and has no side effects, only experiencing 'healing crises' which are considered steps towards better health.

As an ancient healing method that is regaining popularity, reflexology is now recognized as an established branch of paramedical medicine and should be accessible to NHS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reflexology--its place in modern healthcare. Sahai, IC.[2004]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Non-pharmacologic management of sickle cell pain. [2011]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. United States pubmed.ncbi.nlm.nih.gov

A pilot study: the effect of healing touch on anxiety, stress, pain, pain medication usage, and physiological measures in hospitalized sickle cell disease adults experiencing a vaso-occlusive pain episode. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Massage for children undergoing hematopoietic cell transplantation: a qualitative report. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events of massage therapy in pain-related conditions: a systematic review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Exploring approaches to patient safety: the case of spinal manipulation therapy. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The SIESTA Trial: A Randomized Study Investigating the Efficacy, Safety, and Tolerability of Acupressure versus Sham Therapy for Improving Sleep Quality in Patients with End-Stage Kidney Disease on Hemodialysis. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Reflexology--its place in modern healthcare. [2004]

11. Scotland pubmed.ncbi.nlm.nih.gov

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