Acupuncture for Post-COVID Syndrome

Overseen By Rachel Geyer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Seizure disorder, Pregnancy, Cancer therapy, 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: 12

Duration: 8 weeks

80 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the idea that Acupuncture for Post-COVID Syndrome is an effective treatment?

The available research shows that acupuncture may help improve symptoms related to Post-COVID Syndrome. One case report highlights a patient benefiting from acupuncture as part of a comprehensive treatment plan. Another study suggests acupuncture can improve the side effects of COVID-19 treatments, which often have harmful side effects. Additionally, acupuncture has been reported to help with respiratory distress and other symptoms like fatigue, anxiety, and depression. However, more research is needed to fully understand its effectiveness. ^{1 2 3 4 5}

What data supports the effectiveness of acupuncture as a treatment for post-COVID syndrome?

Acupuncture has been shown to help with various symptoms related to COVID-19, such as improving lung function, reducing fatigue, anxiety, and depression, and alleviating respiratory distress. It is considered a useful addition to supportive care for COVID-19-related symptoms, as seen in case reports and reviews. ^{1 2 3 4 5}

What safety data is available for acupuncture treatments?

Acupuncture is generally considered safe, but it can have adverse events (AEs). Systematic reviews and studies have identified four major categories of AEs: organ or tissue injuries, infections, local reactions, and other complications like dizziness. Serious AEs are rare but can occur, sometimes leading to mortality. The most common complications are infections, often bacterial, due to improper needle use. Ensuring acupuncturists are well-trained and follow safety guidelines, such as the Clean Needle Technique, is crucial for minimizing risks. ^{6 7 8 9 10}

Is acupuncture generally safe for humans?

Acupuncture is generally considered safe, but it can have some risks. Serious issues like organ injuries and infections are rare, but minor problems like dizziness or local reactions can happen. It's important to ensure the acupuncturist is well-trained to minimize these risks. ^{6 7 8 9 10}

Is acupuncture a promising treatment for Post-COVID Syndrome?

Acupuncture is a promising treatment because it has been shown to help with pain relief in various conditions, such as after surgery and chronic pain. It is a common alternative medicine that can effectively manage pain and improve recovery. ^{11 12 13 14 15}

How is acupuncture different from other treatments for post-COVID syndrome?

Acupuncture, including variations like electroacupuncture and hand acupuncture, is unique because it involves inserting thin needles into specific points on the body to relieve symptoms, which is different from conventional drug treatments. It is often used for pain management and may offer benefits for post-COVID syndrome by potentially improving pain and other symptoms without the use of medication. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this preliminary study is to test methods and procedures to be used in a fully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, we will test the feasibility of conducting a 2-arm randomized clinical trial for evaluating the effectiveness of acupuncture for pain in patients with long COVID. Researchers will compare pain intensity and impact on general activities over 5 months in those who receive acupuncture treatment compared to patients who are receiving usual long COVID care. Participants will complete 4 online surveys at weeks 0, 4, 8, and 20. These surveys include validated mental and physical health questionnaires. Participants who are randomly selected to receive the intervention will receive 8 acupuncture treatment sessions.

Research Team

Nikki Gentile, MD, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for individuals experiencing pain due to long COVID. Participants must be willing to complete online health surveys and attend acupuncture sessions if selected. Specific inclusion and exclusion criteria details are not provided, but typically involve factors like age, overall health status, and the severity of symptoms.

Inclusion Criteria

My pain level has been 4 or higher in the past week.

I have had COVID-19 before.

I have had pain, such as joint or headache, for over 12 weeks after a COVID-19 infection.

Exclusion Criteria

I have a high-risk seizure disorder with recent changes or uncontrolled triggers.

I am currently undergoing treatment for cancer.

Is currently Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weekly acupuncture treatment sessions for long COVID-related pain

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

4 online surveys at weeks 0, 4, 8, and 20

Treatment Details

Interventions

• Acupuncture

Trial Overview The study is testing whether acupuncture can help reduce pain in patients with long COVID compared to usual care. It's a preliminary study designed as a randomized clinical trial where some participants will receive acupuncture over five months while others continue their regular treatments.

Participant Groups

Group I: Acupuncture Experimental Treatment 1 Intervention

Participants will receive 8 sessions of acupuncture treatment

Group II: Usual Care Active Control 1 Intervention

Participants will continue to receive any current or recommended treatments from their doctors for their long COVID symptoms.

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?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

A 50-year-old woman with post-COVID syndrome experienced significant symptom relief, including resolution of chest pressure and palpitations, after just one acupuncture treatment, followed by complete recovery after a total of seven sessions combined with symptom-titrated physical activity.

The case suggests that acupuncture may be a beneficial component of a multidisciplinary approach to treating post-COVID syndrome, although further research is needed to isolate its effects from concurrent therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture in Multidisciplinary Treatment for Post-COVID-19 Syndrome. Trager, RJ., Brewka, EC., Kaiser, CM., et al.[2022]

This systematic review aims to evaluate the effectiveness and safety of acupuncture therapy for COVID-19 patients by analyzing randomized controlled trials published up to May 2020, focusing on primary outcomes like symptom disappearance and serum cytokine levels.

The study will assess a wide range of secondary outcomes, including the rate of negative COVID-19 results, clinical cure rates, and hospitalization times, to provide comprehensive evidence on the potential benefits of acupuncture in treating COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of acupuncture on the quality of life of patients recovering from COVID-19: A systematic review protocol. Wen, D., Wu, L., Dong, Y., et al.[2022]

This study aims to evaluate the efficacy of acupuncture in alleviating the side effects of western medicine treatments for COVID-19, which can include serious complications like heart and liver issues.

The systematic review will assess various health outcomes, including mortality rates and clinical symptoms, while also monitoring the safety of acupuncture, making it a comprehensive approach to understanding its potential benefits for COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of acupuncture for improving the side effects of COVID-19 western medicine treatments: A protocol for a systematic review and meta-analysis. Huang, KY., Chang, CH., Hsu, CH.[2022]

Acupuncture may help alleviate various symptoms related to COVID-19, such as respiratory, digestive, and mental health issues, by reducing inflammation and regulating the body's stress response, as suggested by a systematic review of existing literature.

The treatment appears to improve lung function and reduce symptoms like fatigue and anxiety, but the exact mechanisms of how acupuncture works in the context of COVID-19 are still not fully understood and require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-effective characteristics and advantages of acupuncture in COVID-19 treatment. Wang, L., Hu, X., Geng, L., et al.[2023]

A case report describes a previously healthy anesthesiologist who contracted COVID-19 and successfully self-treated her pneumonia symptoms using cupping therapy and acupuncture, suggesting these methods may aid recovery.

The findings indicate that acupuncture could be a beneficial adjunct therapy in the supportive care of patients suffering from symptomatic COVID-19 pneumonia, highlighting its potential role in managing respiratory distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Acupuncture as a Treatment for Novel COVID-19-Related Respiratory Distress: Personal Experience from a Frontline Anesthesiologist. Cheng, SI.[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]

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]

Acupuncture has a relatively low risk of adverse events (AEs), with at least one AE occurring in about 9.31% of patients undergoing treatment, and serious adverse events (SAEs) being very rare at approximately 1.01 per 10,000 patients.

The most common minor AEs are mild reactions such as bleeding or pain at the needle site, which are often considered intended effects of acupuncture, highlighting the need for standardized assessment tools to differentiate between adverse reactions and therapeutic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. Bäumler, P., Zhang, W., Stübinger, T., et al.[2021]

A review of adverse events (AEs) from acupuncture, moxibustion, and cupping between 2000 and 2011 identified 308 AEs, with infections being the most common complication, particularly bacterial infections from skin contact at acupoint sites.

The study highlights the importance of following safety guidelines, like the Clean Needle Technique, to minimize the risk of infections during acupuncture, as previous concerns about hepatitis from reusable needles were not found in this review.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of acupuncture: a systematic review of case reports. Xu, S., Wang, L., Cooper, E., et al.[2022]

A review of 8 hand acupuncture schools revealed inconsistencies in positioning methods and needling techniques, as well as a lack of clarity on the specific diseases treated, highlighting the need for standardization.

Future research should focus on optimizing hand acupuncture practices, developing quantitative standards, and promoting integration among different acupuncture schools to enhance the effectiveness and application of hand acupuncture therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of different schools of hand acupuncture therapies]. Wang, RQ., Zhang, ZD., Liu, JX., et al.[2021]

This systematic review aims to evaluate the effectiveness and safety of acupuncture for managing postoperative pain in patients after laparoscopic surgery, analyzing data from various international databases.

The review will include randomized controlled trials and assess the risk of bias, potentially providing valuable insights for clinicians and patients regarding the use of acupuncture in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for postoperative pain in laparoscopic surgery: a systematic review protocol. Lee, S., Park, J., Kim, J., et al.[2019]

A study involving 106 patients with chronic post-traumatic pain syndrome found that acupuncture analgesia is effective in treating pain, but the infrared thermography (IRT) method was more effective overall compared to traditional methods.

Electroanalgesia provided quicker pain relief and better restoration of vegetative and trophic functions than acupuncture, suggesting it may be a faster option for managing pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of acupuncture analgesia in the treatment of chronic post-traumatic pain syndromes]. Tkachuk, VN., Medvedev, IP., Bachurin, EP.[2011]

A case report describes a 47-year-old immunosuppressed woman who developed a rare but serious intracranial abscess after receiving acupuncture for headaches, highlighting a potential risk associated with this alternative treatment.

The patient was successfully treated with targeted antibiotics following surgical evacuation of the abscess, emphasizing the importance of recognizing and managing complications from acupuncture, especially in immunocompromised individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-Induced Cranial Epidural Abscess: Case Report and Review of the Literature. Priola, SM., Moghaddamjou, A., Ku, JC., et al.[2020]

In a study of 72 patients undergoing laparotomy for gynecological diseases, combined electroacupuncture and auricular acupuncture significantly reduced pain at rest compared to a sham control, particularly at 22 hours post-surgery.

While the acupuncture group reported lower pain scores, the overall efficacy of acupuncture for postoperative pain management remains inconclusive, as no significant differences were found in other outcomes and no serious adverse events occurred.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combination of electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynaecological diseases: A randomized controlled trial. Lam, WL., Wang, J., Yeung, WF., et al.[2022]

References

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

Acupuncture in Multidisciplinary Treatment for Post-COVID-19 Syndrome. [2022]

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

The effect of acupuncture on the quality of life of patients recovering from COVID-19: A systematic review protocol. [2022]

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

The efficacy of acupuncture for improving the side effects of COVID-19 western medicine treatments: A protocol for a systematic review and meta-analysis. [2022]

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

Multi-effective characteristics and advantages of acupuncture in COVID-19 treatment. [2023]

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

Medical Acupuncture as a Treatment for Novel COVID-19-Related Respiratory Distress: Personal Experience from a Frontline Anesthesiologist. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

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

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. [2021]

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

Adverse events of acupuncture: a systematic review of case reports. [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Comparison of different schools of hand acupuncture therapies]. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Acupuncture for postoperative pain in laparoscopic surgery: a systematic review protocol. [2019]

13. Ukraine pubmed.ncbi.nlm.nih.gov

[Effectiveness of acupuncture analgesia in the treatment of chronic post-traumatic pain syndromes]. [2011]

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

Acupuncture-Induced Cranial Epidural Abscess: Case Report and Review of the Literature. [2020]

15. Germany pubmed.ncbi.nlm.nih.gov

A combination of electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynaecological diseases: A randomized controlled trial. [2022]