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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of acupuncture in easing pain for individuals with sickle cell disease. Researchers aim to understand both the efficacy of acupuncture and the underlying mechanisms of its benefits. The trial includes various approaches, such as traditional needling and laser acupuncture, over different time periods. It suits individuals with sickle cell disease who experience ongoing pain or painful episodes and are currently taking or willing to manage pain medications. Participants should be able to attend sessions and should not have received recent acupuncture treatment for pain. As an unphased trial, this study offers an opportunity to contribute to groundbreaking research that could enhance pain management strategies for sickle cell disease.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that acupuncture is generally safe when performed by trained professionals. Studies have found that traditional acupuncture, which involves inserting thin needles into the skin, is safe and well-tolerated by both adults and children. These studies reported no major side effects, making it a viable option for managing pain.

Similarly, laser acupuncture, which uses light instead of needles, has also demonstrated safety. One study found no side effects from laser acupuncture, suggesting it is a safe, non-drug option for managing pain in people with sickle cell disease. Both types of acupuncture appear safe and may help reduce pain without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about acupuncture for pain in sickle cell disease because it offers a unique, non-pharmaceutical approach to managing pain. Unlike standard care options like opioids and NSAIDs that can have significant side effects, acupuncture provides a holistic alternative that may reduce pain without medication. The study is exploring two forms of acupuncture: needling and laser. Needling acupuncture involves inserting thin needles into specific points on the body, while laser acupuncture uses focused light instead of needles. These methods could potentially offer safer, effective pain relief, enhancing quality of life for those with sickle cell disease.

What evidence suggests that this trial's acupuncture treatments could be effective for pain in sickle cell disease?

Research has shown that acupuncture can help reduce pain in people with sickle cell disease. In this trial, participants will receive either needling acupuncture or laser acupuncture. Studies have found that needling acupuncture led to a noticeable drop in pain immediately after treatment. In another review, 65.5% of children experienced pain relief with acupuncture. Laser acupuncture also appears promising, with 75% of patients reporting less pain after sessions. These findings suggest that both needle and laser acupuncture might be effective options for managing pain in sickle cell disease. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Right-handed

I am between 14 and 80 years old.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4159140/

A retrospective review of acupuncture use for the treatment of ... Excluding the 2 patients with highest number of sessions, 75% of patients described their pain as improved compared to prior session. In 10.4% of the treatment ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06725550

Integrative Medicine in Pain Management in Sickle Cell ... The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupuncture analgesia in patients with sickle cell disease.

3. withpower.com withpower.com/trial/phase-anemia-sickle-cell-5-2021-dd2f6

Acupuncture for Sickle Cell Disease Pain Management A retrospective review of 90 acupuncture treatments in 24 pediatric patients with sickle cell disease showed that acupuncture effectively reduced pain in 65.5% ...

4. researchgate.net researchgate.net/publication/311163628_Laser_acupuncture_to_manage_pain_in_child_with_sickle_cell_disease_Case_report

Laser acupuncture to manage pain in child with sickle cell ... CONCLUSION: Initial symptoms were significantly decreased with laser acupuncture and we decided to continue with the treated designed to further ...

5. ashpublications.org ashpublications.org/bloodadvances/article/3/23/3982/429244/End-points-for-sickle-cell-disease-clinical-trials

End points for sickle cell disease clinical trials There are no published data in which QST has been used as an end point in a clinical trial targeted at pain treatment. Studies have correlated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8530874/

Acupuncture for chronic pain in adults with sickle cell disease It was feasible and acceptable to implement acupuncture in adults with SCD. This study can be used to guide a larger randomized controlled trial to evaluate the ...

7. ctv.veeva.com ctv.veeva.com/study/integrative-medicine-in-pain-management-in-sickle-cell-disease-1

Integrative Medicine in Pain Management in Sickle Cell ... 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 ...