What side effects are associated with this type of intervention?

Common treatments for foot fractures include immobilization with casts or splints, surgical intervention, and pain management with medications. Immobilization can lead to side effects such as skin irritation, muscle atrophy, and joint stiffness. Surgical interventions may result in infection, nerve damage, and complications related to anesthesia. Pain management often involves the use of opioids, which carry risks of addiction, constipation, and respiratory depression. Intraoperative electro auricular acupuncture, being studied for its potential to reduce opioid use, may cause mild side effects such as local irritation, dizziness, and minor bleeding at the needle insertion sites.

What prior FDA approvals exist?

The FDA has approved various treatments for managing pain associated with foot fractures. Pharmacologic treatments include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and acetaminophen for pain relief. Opioids may be prescribed for severe pain, though their use is generally limited due to the risk of addiction. Non-pharmacologic treatments that modulate pain pathways include transcutaneous electrical nerve stimulation (TENS) and other forms of neuromodulation. While intraoperative electro auricular acupuncture is still under investigation, these approved treatments share the goal of reducing pain perception through different mechanisms.

What other types of research exist?

Promising novel alternatives for pain management in foot fracture patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown significant pain reduction in migraine patients and could be adapted for postoperative pain. 2) Remote electrical neuromodulation, which uses nonpainful electrical skin stimulation and has demonstrated efficacy in reducing acute migraine pain. 3) Transcranial magnetic stimulation, which has been effective in reducing headache days and could potentially be applied to postoperative pain management. These alternatives offer nonpharmacologic options that modulate pain pathways and reduce pain perception.

← Back to Search

Auricular Acupuncture for Postoperative Pain After Lower Leg Fracture

N/A

Recruiting

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient ages 18-64

American Society of Anesthesiology Physical Status I, II or III

Must not have

Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)

Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Auricular acupuncture may cause minor side effects such as local discomfort, bleeding, infection at the needle sites, dizziness or nausea. However, it's generally considered safe and these events are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 64 years old.

Select...

My overall health is good to moderately impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can communicate clearly without any major issues.

Select...

My kidney function is normal, with a creatinine level at or below 1.2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total opioid analgesic use for 14 days after surgery

Secondary study objectives

Incidence of side effects associated with opioid use

Pain scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Electroauricular acupunctureExperimental Treatment1 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 acupunctureActive Control1 Intervention

No acupuncture treatment given

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Auricular acupuncture

2013

Completed Phase 3

~1090

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for foot fractures include immobilization, surgical intervention, and pain management strategies such as medications and physical therapy. Intraoperative electro auricular acupuncture, a technique being studied for its potential benefits, works by modulating pain pathways and reducing pain perception through electrical stimulation of specific auricular points. This method can help decrease postoperative opioid use, which is crucial for minimizing the risk of addiction and side effects. For foot fracture patients, effective pain management is essential for promoting healing, improving mobility, and enhancing overall quality of life.

Electroacupuncture For Alleviation Of Phantom Limb Pain.[Clinical observation on common peroneal nerve palsy treated with comprehensive therapy].