Acupuncture for Pain in Sickle Cell Disease

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: 11

Duration: 5-12 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 during the study.

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

Research suggests that acupuncture may help manage pain in sickle cell disease, as it has been shown to improve pain experiences in children with sickle cell disease and is considered a promising non-opioid therapy. Additionally, acupuncture has been effective in other pain conditions, indicating potential benefits for sickle cell pain management. ^{1 2 3 4 5}

Is acupuncture safe for humans?

Research shows that acupuncture is generally safe for humans, but like any treatment, it can have some side effects. A review of studies in China found that adverse events (unwanted effects) can occur, but they are usually mild, such as minor pain or bruising at the needle site. ^{1 3 5 6 7}

How is acupuncture different from other treatments for sickle cell disease pain?

Acupuncture is a non-drug treatment that offers a promising alternative to opioids for managing pain in sickle cell disease, with fewer side effects. It involves inserting thin needles into specific points on the body to relieve pain, and it has been shown to be effective even when other conventional therapies fail. ^{1 3 4 5 8}

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 individuals with sickle cell disease experiencing pain. Specific details about who can join are not provided, but typically participants must meet certain health criteria and may need to agree to undergo various tests like MRI or EEG as part of the study.

Inclusion Criteria

My gender does not affect my eligibility.

I am between 14 and 80 years old.

Right-handed

Exclusion Criteria

I am suspected of or confirmed to have Covid-19.

I have a chronic pain condition worse than sickle cell pain.

I have received acupuncture for pain management in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

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

5-12 weeks

10-12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Monthly visits (in-person)

Treatment Details

Interventions

• Acupuncture

Trial Overview The study is testing the effectiveness of two types of acupuncture—needling and laser—in managing pain in patients with sickle cell disease. It also aims to understand how acupuncture affects brain activity related to pain.

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+

Findings from Research

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]

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]

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]

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]

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]

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 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. Scotland pubmed.ncbi.nlm.nih.gov

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

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. Scotland pubmed.ncbi.nlm.nih.gov

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

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

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

5. 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]

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

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

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

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