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OpenTrials
Completed

NCT Number: NCT06099223

Preoperative Acupuncture for Total Knee or Hip Arthroplasty

Open-label, randomized controlled trial to determine the effect of preoperative acupuncture on preoperative anxiety and postoperative pain for high-anxiety patients undergoing total hip or knee arthroplasty. The hypothesis is that preoperative acupuncture will reduce preoperative anxiety, reduce postoperative pain, reduce postoperative nausea and vomiting, reduce opioid consumption, and improve patient satisfaction.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bone and Joint Institute- Hartford Hospital

Hartford, Connecticut, 06106, United States

About this study

Acupuncture has been extensively practiced and studied worldwide, particularly as a part of Eastern medicine, but it is a relatively uncommon therapy offered in Western medical institutions, such as those in the United States. Considering the commonly cited benefits of acupuncture, such as reduced anxiety and pain, hospitals throughout the United States have the opportunity to implement acupuncture as a cost-effective and safe technique for improving surgical outcomes.

Acupuncture administered in the preoperative period can be particularly effective for reducing preoperative anxiety, postoperative pain, postoperative opioid consumption, and postoperative nausea and vomiting. Consequently, preoperative acupuncture can improve patient satisfaction and decrease hospital costs. However, due to a lack of implementation and experience, further research is needed to establish the safety and efficacy of preoperative acupuncture in United States medical practices.

At the Bone-and-Joint Institute at Hartford Hospital, where this study is proposed, a quality study on total knee or hip arthroplasty patients found that 21% of its monthly patients were "high-anxiety" according to the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Thus, there is a significant population of patients who would benefit from a procedure to reduce preoperative anxiety at our facility.

This proposal is for a prospective, open-label, randomized controlled trial to determine the effect of preoperative acupuncture on preoperative anxiety and postoperative pain for high-anxiety patients undergoing total hip or knee arthroplasty. The hypothesis is that preoperative acupuncture will reduce preoperative anxiety and postoperative pain as well as reduce postoperative nausea and vomiting and opioid consumption and improve patient satisfaction. The study population is to include adult patients undergoing lower extremity total joint arthroplasty, including hip and knee joints, at the Bone-and-Joint Institute at Hartford Hospital.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female (age 52 to 85) or male (age 18-85) patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty at the Bone-and Joint Institute at Hartford Hospital
  • Patients classified as high-anxiety based on having a score of >10 on the Amsterdam Preoperative Anxiety and Information Scale (APAIS-A-T). The APAIS-A-T is a modified survey that reliably quantifies total preoperative anxiety using summed scores for anesthesia and surgery-related anxiety; a minimum score of 11 is the most accurate cutoff to identify patients with anxiety

Exclusion criteria

  • Unable to give consent
  • Uncontrolled diabetes (HbA1c ≥ 8.0%)
  • Infection at any of the acupuncture points
  • Known allergy to metals
  • Abnormal laboratory blood work values (INR>1.5, if available; platelet count <70,000, if available)
  • Patients with active ongoing coagulopathy based on lab data (INR >1.5) and/or on current anticoagulant use which increases bleeding risk.
  • Non-English speaking
  • Revision TKA or THA
  • Women of reproductive age or under the age of 52 years old, as acupuncture is not recommended during pregnancy. They were excluded due to the potential conflict between our institute's standard timing for pregnancy tests on the day of surgery and the scheduled preoperative acupuncture session for the study, to avoid unwanted delays in the operating room schedule.

Treatment and study plan

Acupuncture needles

Device

The acupuncture intervention includes a combination of auricular and body acupuncture. The auricular points used are Shen men, Zero point, Tranquilizer point, and Master cerebral.

The body points used are the wrist PC6.

Other names: DBC™ Detox-5 Acupuncture Needles (SKU: DTX.20X13) and ure needles o 1) SEIRIN J-Type Acupuncture Needles (SKU: SJ.18X30)

Primary outcomes

  1. Perioperative Anxiety

    Time frame: Prior to acupuncture and 30 minutes after acupuncture

    Determine the effect of preoperative acupuncture on preoperative anxiety in the acupuncture group using VAS (Visual Analog Scale) which is a 10 centimeters line in length, from 0-100, with 0 at the left extreme being "not at all anxious" and 100 at the right extreme being "very anxious". Participants put a cross on the line to indicate how they felt at the time point used. A higher score means worse as it means high anxiety.

  2. Postoperative Pain in the First 3 Postoperative Hours

    Time frame: Total mean pain in the first 3 postoperative hours

    Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is "no pain" and 10 is "severe pain". Using the mean pain score to compare the mean of the total pain in the first 3 postoperative hours between groups.

Secondary outcomes

  1. Patient Satisfaction With Acupuncture Procedure

    Time frame: Within 1 week after hospital discharge

    Patients' satisfaction with acupuncture intervention was assessed in the acupuncture group only using the satisfaction scale of (1-5), where 1 is Extremely satisfied, 2 is Very satisfied, 3 is Somewhat satisfied, 4 is Not very satisfied, and 5 is Not at all satisfied. Each frequency represented the percentage of patients who were satisfied (given a score of 1 or 2 out of 5) with their acupuncture treatment. This assessment was done within a week after discharge, via a phone call.

  2. Preoperative Pain

    Time frame: Prior to acupuncture and 30 minutes after acupuncture

    Determine the effect of preoperative acupuncture on preoperative pain in the acupuncture group using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is "no pain" and 10 is "severe pain". Using the mean pain score to compare pre-acupuncture pain to post-acupuncture pain score in the acupuncture group only.

  3. Opioid Consumption

    Time frame: During hospitalization, up to 24 hours post surgery

    Postoperative opioid consumption to be converted into morphine milliequivalents (MMEs) and compared between the two groups for up to 24 hours post surgery.

  4. Midazolam Use as Anxiolytic Medications

    Time frame: During hospitalization, up to 24 hours post surgery

    The dose of Midazolam as an anxiolytic medication that was given at any time throughout hospitalization up to 24 postoperative hours.

  5. Patient Satisfaction Scale With Overall Care

    Time frame: Within 1 week after hospital discharge

    Patients' satisfaction with overall care management was compared using the patient satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied with overall care. Each frequency represents the percentage of patients in each group who have been either satisfied or extremely satisfied (given a score of 9 or 10 out of 10). This assessment was done within a week after discharge, via a phone call.

  6. Occurrence of Nausea and Vomiting at First Postoperative Hour

    Time frame: At 1 postoperative hour

    Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale was used to report the occurrence of nausea (yes/no), with "yes" defined as any number above 0 in the scale, while "no" defined as 0.

  7. Antiemetic Medications

    Time frame: During hospitalization, up to 24 hours post surgery

    The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours

  8. Hospital Length of Stay

    Time frame: From the date and time of admission to the date and time of discharge, assessed as 24-48 hours

    Using the hospital admission and discharge dates & times; this will be compared between the two groups.

  9. Postoperative Pain Upon Arrival to the PACU

    Time frame: Postoperative pain at time of PACU arrival

    Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is "no pain" and 10 is "severe pain". Using the mean pain score to compare the mean pain scores between groups upon arrival to the PACU.

  10. Postoperative Pain at 1 Postoperative Hour

    Time frame: At the first postoperative hour

    Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is "no pain" and 10 is "severe pain". Using the mean pain score to compare the mean of pain scores at the first postoperative hour between groups.

  11. Postoperative Pain After 3 Postoperative Hours

    Time frame: After three postoperative hours

    Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is "no pain" and 10 is "severe pain". Using the mean pain score to compare the mean pain scores after three postoperative hours between groups.

  12. Number of Participants That Received Midazolam Dose >2mg

    Time frame: During hospitalization up to 24 postoperative hours

    The number of participants who received a dose of midazolam exceeding 2 mg indicated a high level of perioperative anxiety that necessitated pharmacological intervention. The decision to use a dose higher than 2 mg was based on the standard practice of administering 2 mg of midazolam for preoperative regional nerve blocks; any dosage surpassing this amount was specifically intended for anxiety management.

  13. Patient's Satisfaction With Pain Management

    Time frame: Within 1 week after hospital discharge

    Patients' satisfaction with their postoperative pain management was compared between groups using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. Each frequency represented the percentage of patients in each group who were satisfied (given a score of 9 or 10 out of 10)This assessment was done within a week after discharge, via a phone call.

  14. Patient's Satisfaction With Anxiety Management

    Time frame: Within 1 week after hospital discharge

    Patients' satisfaction with their perioperative anxiety management was compared between groups using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. Each frequency represented the percentage of patients in each group who were satisfied (given a score of 9 or 10 out of 10). This assessment was done within a week after discharge, via a phone call.

  15. Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries

    Time frame: Within 1 week after hospital discharge

    Patients with acupuncture intervention were assessed for how likely to consider acupuncture for future surgeries using a scale of (1-4), where 1 is Very likely, 2 is Likely, 3 is Maybe, and 4 is Never. Each frequency represented the percentage of patients who were more likely (given a score of 1 or 2 out of 4) to receive acupuncture treatment in a future surgery. This assessment was done within a week after discharge, via a phone call.

  16. Occurrence of Nausea and Vomiting After 3 Postoperative Hours

    Time frame: After 3 postoperative hours

    Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale was used to report the occurrence of nausea (yes/no), with "yes" defined as any number above 0 in the scale, while "no" defined as 0.

  17. Postoperative Pain in the First 3 Postoperative Hours (Group X Time)

    Time frame: Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour

    Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is "no pain" and 10 is "severe pain". To compare mean pain scores between groups, considering all 3 individual time points (at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour)

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Official study title

Open-Label Randomized Controlled Trial to Assess Preoperative Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty

Acronym: (Acupuncture)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2023
Registry last updated
Mar 26, 2025

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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