Acupuncture for Acute Pain

(ACUITY Trial)

Recruiting in Cleveland (>99 mi)

+4 other locations

Overseen By Jeffery A Dusek, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Opioids

Disqualifiers: Fever, Pregnancy, Migraine, COVID-19, 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: 1

Duration: 9 months

290 Participants Needed

Trial Summary

What is the purpose of this trial?

Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a \~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (\~10 per site) and acupuncture patients (\~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken oral opioid medication within 4 hours before the trial.

What data supports the effectiveness of acupuncture as a treatment for acute pain?

Research shows that acupuncture can provide immediate pain relief, with studies indicating it is more effective than sham acupuncture and analgesic injections. Additionally, acupuncture has been found to improve patient satisfaction and has a low risk of side effects, making it a promising option for managing acute pain. ^{1 2 3 4 5}

Is acupuncture generally safe for humans?

Acupuncture is generally considered safe when performed by well-trained practitioners, but it can have minor and serious side effects. Serious issues like organ injuries and infections are rare but possible, so it's important to ensure the acupuncturist is properly trained. ^{6 7 8 9 10}

How is acupuncture different from other treatments for acute pain?

Acupuncture is unique because it involves inserting needles into specific body areas to trigger a physical response, which can help manage pain without the need for drugs. It can be used alone or alongside pain medications, and it is based on traditional Chinese medicine principles, offering a different approach compared to conventional pain treatments. ^{11 12 13 14 15}

Research Team

M. Diane McKee, MD

Principal Investigator

University of Massachusetts, Worcester

Jeffery A Dusek, PhD

Principal Investigator

University California-Irvine

Eligibility Criteria

This trial is for adults over 18 with acute non-emergent pain from injuries like muscle or back pain, who rate their pain at least a 4 out of 10. They must speak English and have a triage rate scale level of 3-5. Excluded are those with psychological issues, dislocations, pregnancy, recent opioid use, migraines, ambulance arrivals/skipping triage, suspected COVID-19 or fever.

Inclusion Criteria

I have pain from an injury that's not a cut, scoring 4 or more out of 10.

Level 3, 4, 5 on triage rate scale

Ability to communicate in English.

Exclusion Criteria

I am seeking help for a mental health concern.

I have taken opioid medication by mouth in the last 4 hours.

I arrived at the hospital in an ambulance or skipped the waiting line.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either acupuncture or usual care for pain management in the emergency department

9 months

Multiple visits as per emergency department protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including satisfaction and retention assessments

1 week

1 visit (virtual or in-person)

Implementation Evaluation

Structured qualitative interviews and direct observation to identify barriers and facilitators of successful implementation

Concurrent with treatment phase

Treatment Details

Interventions

• Acupuncture
• Usual care for pain management

Trial Overview The study tests acupuncture against usual care for managing acute pain in the emergency department. It's a two-arm feasibility trial across three sites to prepare for a larger future study. Participants will be randomly assigned to either receive acupuncture or the standard treatment.

Participant Groups

Group I: Acupuncture Experimental Treatment 2 Interventions

This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.

Group II: Usual Care Active Control 1 Intervention

This arm will receive usual care for pain management.

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?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Findings from Research

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 review of 23 observational studies on acupuncture-related adverse events revealed that many did not provide sufficient information to determine the cause of complications, highlighting a gap in reporting quality.

The study emphasizes the need for better involvement of acupuncture experts in reporting adverse events to improve the understanding and safety of acupuncture practices, particularly regarding infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. Kim, TH., Kang, JW., Park, WS.[2022]

A review of 10 randomized controlled trials on acupuncture for pain relief found that only 6 studies reported adverse events, and most did not adequately detail how these events were collected or assessed.

The findings indicate that acupuncture trials have not fully adhered to the updated CONSORT guidelines for reporting adverse events, highlighting the need for improved documentation to ensure patient safety and better understanding of potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in acupuncture clinical trials focusing on pain. Capili, B., Anastasi, JK., Geiger, JN.[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]

Case reports of adverse events related to acupuncture are often published in non-acupuncture journals by authors lacking acupuncture training, which may limit their usefulness for learning and improving practice.

To enhance the value of these case reports, it is important to include detailed information about the patient, therapist, acupuncture points treated, and the needling technique used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for case reports of adverse events related to acupuncture. Peuker, E., Filler, T.[2019]

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]

References

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

The Immediate Analgesic Effect of Acupuncture for Pain: A Systematic Review and Meta-Analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Electro-acupuncture versus conventional analgesia: a comparison of pain levels during oocyte aspiration and patients' experiences of well-being after surgery. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Review article: Does acupuncture have a role in providing analgesia in the emergency setting? A systematic review and meta-analysis. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Auricular acupuncture in the treatment of acute pain syndromes: A pilot study. [2022]

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

Mechanisms of acupuncture analgesia: effective therapy for musculoskeletal pain? [2019]

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

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

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

The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. [2022]

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

Adverse event reporting in acupuncture clinical trials focusing on pain. [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

Guidelines for case reports of adverse events related to acupuncture. [2019]

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

[Professor WU Xu's clinical experiences on acupuncture for acute upper abdominal pain]. [2014]

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

DoD-NCCAM/NIH workshop on acupuncture for treatment of acute pain. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process. [2023]

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

Acupuncture for management of pain. [2019]

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

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