Auricular Acupuncture for Postoperative Pain After Lower Leg Fracture

Overseen By Jaime Ortiz, MD, MBA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Renal dysfunction, Allergy, Communication issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding ear acupuncture (also known as auricular acupuncture) during surgery can reduce the need for painkillers like opioids after repairing a broken lower leg. Researchers seek to understand if this acupuncture treatment can enhance pain management when combined with standard pain relief methods. Participants will either receive the acupuncture treatment or not, allowing for a comparison of results. The trial seeks patients scheduled for ankle surgery who do not have kidney issues or allergies to anesthesia. As an unphased trial, it offers patients the opportunity to explore innovative pain management options beyond traditional methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this auricular acupuncture protocol is safe for postoperative pain management?

Research has shown that auricular acupuncture, which involves stimulating specific spots on the ear, is generally safe for pain relief. In various studies, participants who received this treatment experienced less pain after surgery compared to those who did not. Importantly, these studies reported no serious side effects from auricular acupuncture, suggesting that patients tolerate it well. While every treatment carries some risk, current evidence indicates this method is a safe option for easing post-surgical pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auricular acupuncture for postoperative pain after lower leg fractures because it offers a non-pharmacological alternative to traditional pain management methods like opioids and NSAIDs. Unlike most standard treatments, which often come with side effects like nausea or addiction risk, auricular acupuncture targets specific ear points related to pain perception and stress response, potentially reducing pain naturally. Moreover, the use of electrostimulation at precise ear points may enhance the body's natural pain-relief mechanisms, offering targeted relief without systemic drug effects. This method is promising for those looking to manage pain effectively while minimizing medication use and its associated risks.

What evidence suggests that auricular acupuncture is effective for reducing postoperative pain after lower leg fracture surgery?

This trial will compare electroauricular acupuncture with no acupuncture for managing postoperative pain after lower leg fracture surgery. Studies have shown that ear acupuncture can effectively manage pain. In a review of various studies, 12 out of 15 found that this therapy significantly reduced pain and the need for painkillers. Ear acupressure, a similar method, also relieves pain and improves patient satisfaction. Research indicates that ear acupuncture is part of a larger pain management strategy that can reduce pain after surgery, especially after procedures like fixing broken bones. Evidence suggests that ear acupuncture might help reduce the need for opioids after surgery. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 who are in good to moderate health and scheduled for ankle surgery at Ben Taub Hospital. They must be able to communicate clearly with researchers. People with kidney issues, allergies to anesthesia, or communication barriers due to language or mental health conditions cannot participate.

Inclusion Criteria

I am scheduled for ankle surgery at Ben Taub Hospital.

My overall health is good to moderately impaired.

Exclusion Criteria

You are allergic to any of the common anesthesia drugs.

I or my surgeon have refused a specific treatment.

I can communicate clearly without any major issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative electro auricular acupuncture as part of a multimodal analgesic regimen during surgery to repair lower leg fractures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for opioid use and pain scores for 14 days post-surgery

14 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Auricular Acupuncture

Trial Overview

The study is testing if auricular acupuncture can reduce the need for opioid painkillers after lower leg surgery when added to standard pain management practices. Patients will receive this treatment during their operation under spinal anesthesia.

How Is the Trial Designed?

Group I: Electroauricular acupuncture Experimental Treatment 1 Intervention

Immediately after Level 2 sedation is achieved, an enhanced auricular trauma protocol (ATP) will be administered on the ear ipsilateral to the operative side at 8 ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) as described by Cheng (2022). The original ATP was described by Helms (2011). Seirin L 0.2 x 30 mm needles will be placed at Hypothalamus and Shen Men points. Seirin J 0.18 x 15 mm needles will be placed at Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Vagus, and Insula points. Electrostimulation using an ITO ES 130 microstimulator at 30 HZ with Level 4 intensity, will be applied with the positive lead (red) on Hypothalamus and negative lead (black) at Shen Men for 60 minutes. All needles will be removed 1 hour after insertion.

Group II: No acupuncture Active Control 1 Intervention

No acupuncture treatment given

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

A review of 23 studies on auricular acupuncture for postoperative pain found that 9 met the criteria for inclusion, with 8 showing that auricular acupuncture was more effective than control conditions.

While the evidence suggests that auricular acupuncture can help reduce postoperative pain, the overall findings are not strong enough to be considered definitive, as the studies varied widely in quality and results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials. Usichenko, TI., Lehmann, Ch., Ernst, E.[2018]

Auricular acupuncture (AA) significantly reduced the need for post-operative analgesics, with patients in the AA group consuming a median of 500 mg of ibuprofen compared to 800 mg in the control group, indicating its potential effectiveness in pain management after knee surgery.

While AA did not show a difference in pain intensity or other recovery parameters between the groups, it suggests that AA could be a beneficial adjunct therapy to lower analgesic requirements following ambulatory knee arthroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular Acupuncture for Pain Relief after Ambulatory Knee Arthroscopy-A Pilot Study. Usichenko, TI., Hermsen, M., Witstruck, T., et al.[2020]

In a study involving 120 patients undergoing total hip arthroplasty, those receiving auricular acupuncture (AA) required 15% less fentanyl for pain management during surgery compared to a sham group, indicating a potential analgesic effect of AA.

The study suggests that while AA may provide modest pain relief, further research is needed to fully understand its effectiveness as a complementary analgesic method in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of auricular acupuncture on fentanyl requirement during hip arthroplasty: a randomized controlled trial. Wetzel, B., Pavlovic, D., Kuse, R., et al.[2022]

A systematic review of various studies found that adverse events from auricular therapy (AT) are generally mild and transient, with common issues including tenderness, dizziness, and local discomfort, but no serious adverse events were reported.

The study highlights the need for improved reporting of adverse events in future AT research, suggesting that while AT appears to be a safe treatment option, more comprehensive data collection is necessary to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. Tan, JY., Molassiotis, A., Wang, T., et al.[2022]

Auricular acupuncture significantly reduced postoperative pain levels in patients undergoing total hip arthroplasty, as indicated by lower VAS scores compared to the control group over several days post-surgery.

Patients receiving auricular acupuncture required less analgesic medication and experienced fewer complications, such as nausea and vomiting, while also showing improved hip joint function two weeks after the operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Case-control study on application of auricular acupuncture for the treatment of analgesia during perioperative period in total hip arthroplasty]. Wang, JF., Bao, HX., Cai, YH., et al.[2012]

Auricular acupuncture (AA) significantly reduced the need for postoperative pain medication (piritramide) in patients after total hip arthroplasty, with the AA group requiring an average of 37 mg compared to 54 mg in the control group.

The study involved 54 patients and showed that while AA effectively lowered analgesic requirements, pain intensity and side effects were similar between the AA and sham acupuncture groups, suggesting AA can be a complementary approach for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Usichenko, TI., Dinse, M., Hermsen, M., et al.[2022]

In a study of 120 patients undergoing ambulatory knee surgery, auricular acupuncture significantly reduced the need for ibuprofen for pain relief compared to a control group, with patients in the acupuncture group requiring a median of only 200 mg versus 600 mg in the control group.

Despite similar pain intensity levels reported by both groups, the majority of patients felt they received effective treatment and expressed interest in using acupuncture again in the future, suggesting a positive perception of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for pain relief after ambulatory knee surgery: a randomized trial. Usichenko, TI., Kuchling, S., Witstruck, T., et al.[2018]

Citations

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pubmed.ncbi.nlm.nih.gov

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The efficacy of auricular acupressure combined with ...

Auricular acupressure combined with EFT effectively reduces pain levels, alleviates anxiety, and increases patient satisfaction with nursing care.

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clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT05984433?draw=2&rank=1

Auricular Acupuncture as Part of Multimodal Analgesia ...

The purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7748313/

Effect of auricular point pressing therapy on postoperative ...

This systematic review explored whether auricular point pressing therapy is effective on the intervention of postoperative pain after fracture.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1524904217303806

Effects of Auricular Acupressure on Pain Management

In 12 of the 15 studies we reviewed, AA therapy revealed statistically significant improvements in decreasing pain severity, analgesic consumption, and adverse ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1155/2014/934670

Efficacy of Auricular Therapy for Pain Management: A ...

Auricular acupressure boasts the largest strength of evidence for pain relief, followed by auricular acupuncture.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10151718/

Clinical Effects and Safety of Auricular Acupressure as an ...

Compared with CT alone, the combination of AA and CRT had a significantly greater effect on postoperative pain in HF patients.

7.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1155/2023/5077772

Clinical Effects and Safety of Auricular Acupressure as an ...

Conclusions. Compared with CT alone, the combination of AA and CRT had a significantly greater effect on postoperative pain in HF patients.