Acupuncture for Postoperative Pain in Wrist Fractures

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: 1

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 auricular acupuncture (a type of acupuncture targeting the ear) during wrist fracture surgery can reduce the need for painkillers afterward. Patients will be divided into two groups: one will receive ear acupuncture, while the other will not. The trial focuses on individuals planning wrist surgery with a specific type of anesthesia, the brachial plexus nerve block. Good candidates are generally healthy individuals planning wrist fracture surgery at a trauma center. As an unphased trial, this study offers patients the opportunity to explore innovative pain management techniques.

Do I need to stop my current medications for this trial?

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 shows that ear acupuncture is generally safe. Most side effects are minor and temporary, such as tenderness or dizziness, and they typically resolve on their own. Studies have found that acupuncture can aid in healing fractures and reducing post-surgical pain, making it a promising option for managing discomfort after operations. Overall, the treatment is well-tolerated, with few reports of serious issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores auricular acupuncture as a unique approach to managing postoperative pain after wrist fracture surgeries. Unlike standard pain relief methods, which often involve medications like NSAIDs or opioids, this technique uses targeted electroacupuncture on the ear, stimulating specific points associated with pain perception and the nervous system. This method could offer a non-drug alternative with potentially fewer side effects, and it taps into a novel mechanism by enhancing the body's natural pain control pathways.

What evidence suggests that auricular acupuncture is effective for reducing postoperative pain in wrist fractures?

Research has shown that ear acupuncture can help manage pain after surgery. In this trial, participants will be assigned to different treatment arms to evaluate its effectiveness. One arm will receive electroauricular acupuncture, which involves an enhanced auricular trauma protocol administered on the ear ipsilateral to the operative side. Previous studies found that patients who had ear acupuncture after wrist surgery needed much less pain medication, like ibuprofen, than those who didn't receive the treatment. Another study found that ear acupuncture significantly lowered pain levels 48 and 72 hours after surgery. This suggests that ear acupuncture might reduce the need for painkillers after surgery. Additionally, acupuncture may help fractures heal faster. Overall, these findings suggest that ear acupuncture could be useful for managing pain and aiding recovery after wrist surgeries. ^{3 4 5 6 7}

Who Is on the Research Team?

Jaime Ortiz, MD, MBA

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 who are in good to moderate health (ASA Physical Status 1, 2, or 3) and scheduled for surgery to fix a broken bone near the wrist under nerve block anesthesia. It's not for those with kidney issues, allergies to anesthetic agents, or communication difficulties.

Inclusion Criteria

I am scheduled for wrist surgery with a specific type of anesthesia.

My health is good to moderately impaired according to anesthesia guidelines.

Exclusion Criteria

My kidney function is normal.

I cannot effectively communicate with my healthcare team.

I or my surgeon have decided against a specific treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative auricular acupuncture or no acupuncture during surgery for distal radius fractures

1 day

1 visit (in-person)

Postoperative Monitoring

Participants' opioid analgesic use and side effects are monitored for 14 days after surgery

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auricular Acupuncture

Trial Overview The study is testing if ear acupuncture during surgery can reduce the need for painkillers after wrist fracture repair. Participants will be randomly assigned to receive either acupuncture or no acupuncture as part of their pain management plan.

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

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]

In a study of 72 patients undergoing laparotomy for gynecological diseases, combined electroacupuncture and auricular acupuncture significantly reduced pain at rest compared to a sham control, particularly at 22 hours post-surgery.

While the acupuncture group reported lower pain scores, the overall efficacy of acupuncture for postoperative pain management remains inconclusive, as no significant differences were found in other outcomes and no serious adverse events occurred.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combination of electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynaecological diseases: A randomized controlled trial. Lam, WL., Wang, J., Yeung, WF., et al.[2022]

Auricular acupuncture (AA) is generally safe, but this case report highlights a rare occurrence where an Aiguille Semi-Permanente® (ASP®) needle was found retained in a patient's external auditory canal after treatment for complex regional pain syndrome.

Acupuncturists should be vigilant for potential complications, such as a foreign-body sensation in the ear, and conduct examinations if patients report unusual symptoms following AA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. Kazal, LA.[2023]

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]

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 (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 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]

Citations

1. 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.

2. withpower.com withpower.com/trial/phase-pain-postoperative-7-2023-8e4c9

Acupuncture for Postoperative Pain in Wrist Fractures 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9713955/

Efficacy of electroacupuncture in assisting postoperative ... Researches suggest that acupuncture is helpful for fracture healing and may accelerate the recovery from postoperative complications [16, 17] ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0965229924001006

The analgesic effectiveness of auriculotherapy for acute ... Notably, at 48 and 72 hours post-surgery, auricular acupressure also showed significantly reduced pain scores compared to the control group. When comparing ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01030029?term=AREA%5BConditionSearch%5D(acupuncture)&rank=6

NCT01030029 | Auricular Acupuncture in Postoperative Pain Auricular acupuncture is also known to be effective in treatment of acute postoperative pain. The aim of our study is to investigate in a ...

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

Clinical Effects and Safety of Auricular Acupressure as an ... To evaluate the short-term outcome of treatment by auricular acupressure (AA) on postoperative pain among hip fracture (HF) patients.

7. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-022-03415-8

Efficacy of electroacupuncture in assisting postoperative ... Researches suggest that acupuncture is helpful for fracture healing and may accelerate the recovery from postoperative complications [16, 17] ...