(Acupuncture): Preoperative Acupuncture for Total Knee or Hip Arthroplasty

Sponsor

Hartford Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06099223

Collaborator

(none)

Enrollment

Location

Arms

13.4

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthropathy Hip Arthropathy Anxiety	Device: Acupuncture needles	N/A

Detailed Description

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. We hypothesize 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-center, prospective, unblinded, randomized controlled clinical trialSingle-center, prospective, unblinded, randomized controlled clinical trial

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 21, 2022

Actual Primary Completion Date :

Apr 3, 2023

Actual Study Completion Date :

May 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acupuncture Preoperative acupuncture	Device: Acupuncture needles 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)
No Intervention: Control No acupuncture

Arm

Intervention/Treatment

Experimental: Acupuncture

Preoperative acupuncture

Device: Acupuncture needles

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)

No Intervention: Control

No acupuncture

Outcome Measures

Primary Outcome Measures

Preoperative Anxiety [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 line 10 centimetres 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.
Postoperative Pain [Upon arrival to the post anesthesia care unit, at 1 postoperative hour, and at 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 postoperative pain between groups.

Secondary Outcome Measures

Preoperative Pain [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.
Opioid consumption [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.
Anxiolytic medications [During hospitalization, up to 24 hours post surgery]
The frequency of any anxiolytic medication given at any time throughout hospitalization up to 24 postoperative hours.
Patient satisfaction with overall pain and anxiety management [Within 1 week after hospital discharge]
Patients' satisfaction with overall pain and anxiety management was compared between groups using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. This assessment was done within a week after discharge, via a phone call.
Patient satisfaction with acupuncture procedure [Within 1 week after hospital discharge]
Patients' satisfaction with acupuncture intervention is to be assessed in the acupuncture group only using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. This assessment was done within a week after discharge, via a phone call.
Incidence of nausea and vomiting [At 1 postoperative hour and at 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.
Antiemetic medications [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
Hospital length of stay [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.