Acupuncture for Sickle Cell Disease Pain Management

Overseen By Ying Wang, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Stimulants

Disqualifiers: Covid-19, Autoimmune diseases, Severe psychiatric, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 5 weeks

60 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications, but you must be willing to limit any new medications or treatments for pain control during the study visits.

What data supports the effectiveness of acupuncture as a treatment for sickle cell disease pain management?

Research suggests that acupuncture may help manage pain in sickle cell disease, as it has been effective in other pain conditions and is considered a promising non-opioid therapy. Some studies report positive outcomes in pain relief for sickle cell patients using acupuncture, highlighting its potential as a simple and convenient treatment option. ^{1 2 3 4 5}

Is acupuncture safe for managing pain in sickle cell disease?

Acupuncture is generally considered safe, but it can have minor side effects like dizziness or local reactions, and rare serious events like organ injuries or infections. It's important to ensure the acupuncturist is well-trained to minimize risks. ^{6 7 8 9 10}

How does acupuncture differ from other treatments for sickle cell disease pain management?

Acupuncture is a unique treatment for sickle cell disease pain management because it is a non-drug therapy that involves inserting thin needles into specific points on the body to relieve pain. Unlike opioids, which are commonly used for pain relief but have many side effects, acupuncture offers a non-opioid alternative that has shown promise in improving pain control without the associated risks of medication. ^{1 2 3 5 11}

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for right-handed individuals aged 14-80 with sickle cell disease (SCD), experiencing chronic pain or vaso-occlusive crises. Participants must be fluent in English, able to travel for study visits, and willing to limit new pain treatments during the trial. Pregnant/nursing individuals, those with coagulation issues, recent acupuncture treatment, certain chronic conditions or severe psychiatric illnesses are excluded.

Inclusion Criteria

Right-handed

I can be treated as an outpatient or inpatient.

I can visit the study site regularly for 5 weeks to receive acupuncture.

Exclusion Criteria

I have not started or changed the dose of stimulant medications in the last 30 days.

I do not have severe vision, hearing, or movement problems affecting study activities.

Known non-SCD related Severe psychiatric illnesses

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either needling or laser acupuncture treatment for pain management in sickle cell disease

5 weeks

10 visits (in-person)

Extended Treatment

Participants receive additional acupuncture sessions, either needling or laser, once per week

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Monthly visits (in-person)

Treatment Details

Interventions

• Acupuncture
• Sham

Trial Overview The study tests the effectiveness of acupuncture as a pain management method in SCD patients against a sham procedure (placebo). It involves scheduled visits for questionnaires and various tests like MRI and EEG over five weeks with up to two acupuncture sessions weekly.

Participant Groups

Group I: Needling Acupuncture - 5 weeks Experimental Treatment 1 Intervention

Needling acupuncture treatment will last 30 minutes per session and will be administered two times per week for 5 weeks. Each subject will receive one course of treatment which contains 10 treatment sessions.

Group II: Needling Acupuncture - 12 weeks Experimental Treatment 1 Intervention

Needling acupuncture treatment will last 30 minutes per session and will be administered once per week for 12 weeks. Each subject will receive one course of treatment which contains 12 treatment sessions.

Group III: Laser Acupuncture - 5 weeks Experimental Treatment 1 Intervention

Laser acupuncture treatment will also last 30 minutes per session and will be administered two times per week for 5 weeks. Each subject will receive one course of laser acupuncture treatment which contains 10 treatment sessions.

Group IV: Laser Acupuncture - 12 weeks Experimental Treatment 1 Intervention

Laser acupuncture treatment will also last 30 minutes per session and will be administered once per week for 12 weeks. Each subject will receive one course of laser acupuncture treatment which contains 12 treatment sessions.

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?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

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]

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]

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]

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]

A systematic review of 115 Chinese-language articles identified 479 cases of adverse events related to acupuncture, with 14 reported deaths, highlighting significant safety concerns.

The most common adverse events included pneumothorax and infections, primarily resulting from improper techniques, indicating a need for improved monitoring and risk management in acupuncture practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: a systematic review of the Chinese literature. Zhang, J., Shang, H., Gao, X., et al.[2022]

Acupuncture can lead to adverse events (AEs), including organ or tissue injuries, infections, local reactions, and other complications, with serious AEs being rare but potentially life-threatening, as highlighted by a review of 17 systematic reviews.

The overall methodological quality of the reviews on acupuncture AEs was mediocre, indicating a need for improved research standards and emphasizing the importance of patient safety and acupuncturist training in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. Chan, MWC., Wu, XY., Wu, JCY., et al.[2022]

Acupuncture is gaining popularity among the public and healthcare providers, but it is important to recognize that it can be associated with both mild and serious adverse events, including rare but potentially fatal complications like septicemia and hepatitis C infection.

Clinicians who practice or recommend acupuncture should be aware of these risks to ensure patient safety and informed decision-making regarding treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of acupuncture. Which are clinically significant? Chung, A., Bui, L., Mills, E.[2022]

In a study involving 1968 patients across three multicenter randomized controlled trials, only 3.76% experienced adverse events from acupuncture, indicating a low risk associated with this therapy.

The most common adverse events were minor, such as subcutaneous haematoma and needle site pain, and all but one patient recovered within two weeks, suggesting acupuncture is generally safe when performed by skilled practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Zhao, L., Zhang, FW., Li, Y., et al.[2021]

In a survey of 37,490 acupuncture treatments conducted by 222 Korean Medicine Doctors, adverse events (AEs) were reported at a frequency of 1,205 per 10,000 treatments, with common AEs including bleeding, needle site pain, and bruising.

Most reported AEs were mild and transient, with only two life-threatening cases that resolved without lasting effects, suggesting that acupuncture performed by qualified practitioners is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of acupuncture by Korean Medicine Doctors: a prospective, practice-based survey of 37,490 consultations. Won, J., Lee, JH., Bang, H., et al.[2022]

In a study involving 10 patients with sickle cell anemia during 16 pain crises, acupuncture provided pain relief in 15 out of 16 episodes, regardless of whether actual acupuncture points or sham sites were treated.

The results indicated that needling at acupuncture points did not significantly outperform treatment at sham sites, suggesting that the act of needling itself may be effective for alleviating pain in sickle cell crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture: an evaluation in the painful crises of sickle cell anaemia. Co, LL., Schmitz, TH., Havdala, H., et al.[2021]

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. Scotland pubmed.ncbi.nlm.nih.gov

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

3. Singapore pubmed.ncbi.nlm.nih.gov

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

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. Scotland pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: a systematic review of the Chinese literature. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Adverse effects of acupuncture. Which are clinically significant? [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. [2021]

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

Safety of acupuncture by Korean Medicine Doctors: a prospective, practice-based survey of 37,490 consultations. [2022]

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

Acupuncture: an evaluation in the painful crises of sickle cell anaemia. [2021]