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Completed

NCT Number: NCT03711734

Acupuncture ACL (Anterior Cruciate Ligament)

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.

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Key information

Conditions

ACL ACL Injury Anesthesia Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture Knee Injuries Leg Injuries Wounds and Injuries

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acupuncture + Standard of Care

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.

Primary outcomes

  1. Bang Blinding Index (BI)

    Time frame: postoperative day 1

    Patients' ability to determine whether or not they received acupuncture. The success of patient blinding in each group will be quantified using Bang Blinding Index (BI) which ranges from min = -1 to max = 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.

Secondary outcomes

  1. Numeric Rating Scale (NRS) Pain at Rest Scores

    Time frame: postoperative day 1

    Numeric Rating Scale (NRS) pain at rest on a scale of 0 (no pain) to 10 (worst pain ever imaginable). A lower score is a better outcome.

  2. Numeric Rating Scale (NRS) Pain With Movement Scores

    Time frame: postoperative day 1

    Numeric Rating Scale (NRS) pain with movement on a scale of 0 (no pain) to 10 (worst pain imaginable). A lower score is a better outcome.

  3. Opioid Consumption

    Time frame: day of surgery through postoperative day 1

    Measured in cumulative oral morphine equivalent. Each patient measured individually and then all patients' measurement was averaged.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2018
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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