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Acupuncture for Postoperative Pain in Wrist Fractures

N/A

Recruiting

Led By Jaime Ortiz, MD, MBA

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

Patients scheduled to undergo distal radius ORIF under brachial plexus nerve block

American Society of Anesthesiologists Physical Status 1, 2, or 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Study Summary

This trial will test if acupuncture can reduce post-surgery opioid use for wrist fractures.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While acupuncture is generally considered safe, potential side effects may include minor bleeding or bruising at needle sites, dizziness, fainting, and rarely infection.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

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

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I am between 18 and 64 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total opioid analgesic use for 14 days after surgery

Secondary outcome measures

Incidence of side effects associated with opioid use

Pain scores

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

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

Acupuncture

2011

Completed Phase 3

~1240

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,272 Total Patients Enrolled

4 Trials studying Postoperative Pain

336 Patients Enrolled for Postoperative Pain

Jaime Ortiz, MD, MBAPrincipal InvestigatorBaylor College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility requirements for participating in this research?

"This clinical trial is admitting 140 participants who are suffering from postoperative pain, and whose age lies between 18-64."

Answered by AI

Does this medical research accept applicants that are of legal adult age?

"The qualifications for this trial necessitate that applicants are aged 18 to 64. There are 77 studies suitable for minors and 454 trials available to individuals over 65 years of age."

Answered by AI

What is the current capacity for this clinical trial?

"Affirmative. The information posted on clinicaltrials.gov demonstrates that the study, which was first released on October 9th 2023, is actively searching for participants to enrol. Approximately 140 patients must be sourced from a single medical centre."

Answered by AI

How many participants are being observed in this trial?

"Affirmative. Clinicaltrials.gov's records indicate that the trial is actively seeking volunteers; it was initially posted on October 9th, 2023 and updated most recently on the same date. A total of 140 individuals must be recruited from one medical facility for this study to continue."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Auricular Acupuncture As Part Of A Multimodal Regimen After Distal Radius Open Reduction and Internal Fixation

Jaime Ortiz 2023. "Auricular Acupuncture As Part Of A Multimodal Regimen After Distal Radius Open Reduction and Internal Fixation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05974254.