Acupuncture for Acute Pain

(ACUITY Trial)

Not currently recruiting at 5 trial 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether acupuncture can effectively treat acute pain compared to the usual care in an emergency department. The study aims to determine how well acupuncture reduces pain, lessens anxiety, and decreases the need for pain medication. Participants will either receive acupuncture or continue with their usual pain treatment. Ideal participants have non-severe pain, such as muscle or back pain from a non-serious injury, and can communicate in English. As an unphased trial, this study allows participants to explore alternative pain management options and contribute to valuable research.

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.

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

Research has shown that acupuncture is generally safe for managing pain. A 2018 review examined data from 12 studies involving over 8,000 people and found that acupuncture was more effective at relieving pain than no treatment. Importantly, serious side effects were rare when proper guidelines were followed.

Other studies have found similar results, indicating that acupuncture can significantly relieve pain without major side effects. In Australia, research confirmed that acupuncture is usually a safe option, with serious complications being uncommon.

Overall, acupuncture is well-tolerated and has a strong safety record, making it a promising option for those considering joining a trial for pain management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about acupuncture for acute pain because it offers a non-pharmaceutical approach to pain management. Unlike standard treatments, which often rely on medications like opioids or NSAIDs, acupuncture involves the strategic insertion of needles to potentially stimulate the body's natural pain-relief processes. This method could reduce reliance on medications, minimizing the risk of side effects and addiction. Plus, acupuncture may provide rapid relief, appealing to those seeking immediate help for acute pain.

What evidence suggests that this trial's treatments could be effective for acute pain?

Studies have shown that acupuncture, which participants in this trial may receive, effectively manages sudden pain. Many reviews have found it to be a promising option for pain relief without relying on painkillers like opioids. Research indicates that acupuncture can lower pain by targeting specific points on the body to release natural pain relievers. Additionally, it is considered safe when performed by trained professionals. Overall, acupuncture is regarded as a helpful non-drug therapy for managing pain. Meanwhile, another group in this trial will receive usual care for pain management. ^{3 6 7 8 9}

Who Is on the Research Team?

M. Diane McKee, MD

Principal Investigator

University of Massachusetts, Worcester

Jeffery A Dusek, PhD

Principal Investigator

University California-Irvine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11404884/

Recent advances in acupuncture for pain relief - PMC Acupuncture therapy has achieved global expansion and shown promise for health promotion and treatment of acute/chronic pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9434305/

Acupuncture Therapy as an Evidence-Based ... The majority of reviews found acupuncture therapy to be an efficacious strategy for acute pain, with potential to avoid or reduce opioid reliance.

3. esmed.org esmed.org/MRA/mra/article/view/6871

Efficacy, Safety and Mechanisms of Acupuncture and ... The secondary aim of this review is to explore animal and human studies on the mechanisms of acupuncture and electroacupuncture in pain relief.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0965229924000980

Machine learning-based bibliometric analysis This study aimed to analyze the themes and topics of the scientific publications related to acupuncture therapy in the past two decades by machine learning.

5. iasp-pain.org iasp-pain.org/resources/fact-sheets/acupuncture-for-pain-relief/

Acupuncture for Pain Relief - International Association ... Acupuncture, a non-pharmacological therapy and a component of Traditional East Asian Medicine, has been shown to be beneficial for pain ...

6. nccih.nih.gov nccih.nih.gov/health/acupuncture-effectiveness-and-safety

Acupuncture: Effectiveness and Safety - nccIH.nih.gov In a 2018 review, data from 12 studies (8,003 participants) showed acupuncture was more effective than no treatment for back or neck pain, and data from 10 ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532287/

Acupuncture - StatPearls - NCBI Bookshelf - NIH Many studies show not only acupuncture leading to superior pain relief for various ailments but also sham acupuncture. However, given the overall positive ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876382018309946

Safety and side effects of acupuncture therapy in Australia Acupuncture is generally a safe modality and serious adverse events after treatment are uncommon when supported with well-established guidelines.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2798899

Use of Acupuncture for Adult Health Conditions, 2013 to ... “Acupuncture was associated with a greater immediate pain relief effect compared to sham acupuncture.” Manheimer et al, 2018, Osteoarthritis ( ...