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

Primary Purpose

Knee Arthropathy, Hip Arthropathy, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture needles
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Arthropathy focused on measuring Acupuncture, Total Knee Arthroplasty, Total hip arthroplasty, Anxiety, Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Bone and Joint Institute- Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Control

Arm Description

Preoperative acupuncture

No acupuncture

Outcomes

Primary Outcome Measures

Preoperative Anxiety
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
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
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
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
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
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
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
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
The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours
Hospital length of stay
Using the hospital admission and discharge dates & times; this will be compared between the two groups.

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06099223
Brief Title
Preoperative Acupuncture for Total Knee or Hip Arthroplasty
Acronym
(Acupuncture)
Official Title
Open-Label Randomized Controlled Trial to Assess Preoperative Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
May 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy, Hip Arthropathy, Anxiety
Keywords
Acupuncture, Total Knee Arthroplasty, Total hip arthroplasty, Anxiety, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, prospective, unblinded, randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Preoperative acupuncture
Arm Title
Control
Arm Type
No Intervention
Arm Description
No acupuncture
Intervention Type
Device
Intervention Name(s)
Acupuncture needles
Other Intervention Name(s)
DBC™ Detox-5 Acupuncture Needles (SKU: DTX.20X13) and ure needles o 1) SEIRIN J-Type Acupuncture Needles (SKU: SJ.18X30)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preoperative Anxiety
Description
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.
Time Frame
Prior to acupuncture and 30 minutes after acupuncture
Title
Postoperative Pain
Description
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.
Time Frame
Upon arrival to the post anesthesia care unit, at 1 postoperative hour, and at 3 postoperative hours
Secondary Outcome Measure Information:
Title
Preoperative Pain
Description
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.
Time Frame
Prior to acupuncture and 30 minutes after acupuncture
Title
Opioid consumption
Description
Postoperative opioid consumption to be converted into morphine milliequivalents (MMEs) and compared between the two groups for up to 24 hours post surgery.
Time Frame
During hospitalization, up to 24 hours post surgery
Title
Anxiolytic medications
Description
The frequency of any anxiolytic medication given at any time throughout hospitalization up to 24 postoperative hours.
Time Frame
During hospitalization, up to 24 hours post surgery
Title
Patient satisfaction with overall pain and anxiety management
Description
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.
Time Frame
Within 1 week after hospital discharge
Title
Patient satisfaction with acupuncture procedure
Description
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.
Time Frame
Within 1 week after hospital discharge
Title
Incidence of nausea and vomiting
Description
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.
Time Frame
At 1 postoperative hour and at 3 postoperative hours
Title
Antiemetic medications
Description
The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours
Time Frame
During hospitalization, up to 24 hours post surgery
Title
Hospital length of stay
Description
Using the hospital admission and discharge dates & times; this will be compared between the two groups.
Time Frame
From the date and time of admission to the date and time of discharge, assessed as 24-48 hours

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Women aged 52-85 were included. women under 52 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.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Bone and Joint Institute- Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Preoperative Acupuncture for Total Knee or Hip Arthroplasty

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