Acupuncture ACL (Anterior Cruciate Ligament)

NCT ID: NCT03711734

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-12-13

Brief Summary

Acupuncture research in regards to PONV has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. In 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations including credible placebo or sham intervention, and thus, blinding. The main purpose of this feasibility trial is to determine whether or not adequate blinding is possible in the intraoperative setting with the patient sedated.

Detailed Description

According to the most recent survey conducted by the national center for complementary and integrative health (a branch of the National Institutes of Health) in 2007, the use of complementary alternative medicine (CAM) has increased significantly from 2002 (the previous survey). In the 2007 survey, in the United States alone, 38% percent of adults and 12% of children use some form of CAM. It has been 10 years since that survey report, there is little doubt that these numbers have only increased. According to the National Center for Health Statistics on the expenditures on CAM in 2012 - for just adults utilizing specialists, such as acupuncturists, $14.1 Billion was spent. With this increasing demand of such treatment modalities by patients, conventional practitioners will need to be, at the very least, well versed enough to recommend for or against these modalities. In addition, the current opioid epidemic is on the forefront of the public mind. Recently declared a public health emergency by the President, alternative means of postoperative pain control is a necessity and integrative medicine is a low cost, safe, and effective adjuvant/alternative

Conditions

ACL; ACL Injury; Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture; Anesthesia

Keywords

Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture + Standard of Care

Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen.

Patients will have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally with electrostimulation at Shen men and Hypothalamus at 30 hz.

Group Type: EXPERIMENTAL

Acupuncture + Standard of Care

Intervention Type: OTHER

Acupuncture is a nonpharmacologic pain management modality that has been shown to provide superior analgesia for acute pain. This will be combined with our facility's standard of care anesthesia and pain management plan.

No acupuncture + Standard of Care

Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen.

Patients will not have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture + Standard of Care

Acupuncture is a nonpharmacologic pain management modality that has been shown to provide superior analgesia for acute pain. This will be combined with our facility's standard of care anesthesia and pain management plan.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients undergoing ACL Surgery with a participating surgeon
• English Speaking
• Patients at least 12 years old
• Planned spinal anesthesia without peripheral nerve block (rescue block is okay)

Exclusion Criteria

• Patients under the age of 12
• Non-English speaking patients
• Patients planning on having general anesthesia
• Planned preop peripheral nerve block
• Patients with the inability to understand/follow study protocol
• Patients with pacemaker/AICD
• Non-native Ear/Previous scarring/surgical manipulation of ear
• Patients with contraindications to intra-op protocol
• Chronic pain patients
• Patients who have regularly used opioids for more than 6 weeks prior to surgery
• Patients with guages in their ears
• Patients who refuse to remove earrings/piercings prior to surgery
• Patients with nickel allergies (needles are made of nickel)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgey

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

References

Cheng SI, Norman RM, DeMeo D, Zhong H, Turteltaub LH, McCarthy MM, Marx RG, Strickland SM, Kelly AM. The Feasibility of Blinding Intraoperative Electro-Auricular Acupuncture Under Neuraxial Anesthesia. Med Acupunct. 2021 Aug 1;33(4):286-294. doi: 10.1089/acu.2021.0003. Epub 2021 Aug 17.

Reference Type: DERIVED

PMID: 34471447 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-1478

Identifier Type: -

Identifier Source: org_study_id