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

Trial Summary

What is the purpose of this trial?

This trial is testing whether using electrical acupuncture on the ear can help reduce the need for strong painkillers for patients having surgery for lower leg fractures with spinal anesthesia. The idea is that this method might help manage pain better, so fewer opioids are needed. Electroacupuncture has been shown to reduce pain and the need for pain relief in various surgical settings.

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 data supports the effectiveness of the treatment Auricular Acupuncture for postoperative pain after lower leg fracture?

Research shows that auricular acupuncture can reduce the need for pain medication after surgeries like hip and knee operations, suggesting it might help with pain after lower leg fracture surgery too. ^{1 2 3 4 5}

Is auricular acupuncture safe for humans?

Auricular acupuncture is generally considered safe for humans, with most reported side effects being mild and temporary, such as tenderness, dizziness, and minor bleeding. No serious adverse events have been identified in the studies reviewed. ^{1 3 4 5 6}

How does auricular acupuncture differ from other treatments for postoperative pain after lower leg fracture?

Auricular acupuncture is unique because it involves stimulating specific points on the ear to help manage pain, which is different from traditional pain medications that are taken orally or injected. This method may reduce the need for painkillers, potentially lowering the risk of side effects associated with those drugs. ^{1 3 4 5 7}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials. [2018]

2. China 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]. [2012]

3. Canada pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for pain relief after ambulatory knee surgery: a randomized trial. [2018]

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

Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. [2022]

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

Auricular Acupuncture for Pain Relief after Ambulatory Knee Arthroscopy-A Pilot Study. [2020]

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

Adverse events of auricular therapy: a systematic review. [2022]

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

The effect of auricular acupuncture on fentanyl requirement during hip arthroplasty: a randomized controlled trial. [2022]