Preoperative Acupuncture for Total Knee or Hip Arthroplasty

Anxiety Clinical Trial

— (Acupuncture)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06099223
• Other study ID #: HHC-2021-0348
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: May 3, 2023

Study information

• Verified date: October 2023
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 3, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Hip Arthropathy
• Joint Diseases
• Knee Arthropathy

Intervention

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.

Locations

Country	Name	City	State
United States	Bone and Joint Institute- Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Prior to acupuncture and 30 minutes after acupuncture
Primary	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.	Upon arrival to the post anesthesia care unit, at 1 postoperative hour, and at 3 postoperative hours
Secondary	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.	Prior to acupuncture and 30 minutes after acupuncture
Secondary	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.	During hospitalization, up to 24 hours post surgery
Secondary	Anxiolytic medications	The frequency of any anxiolytic medication given at any time throughout hospitalization up to 24 postoperative hours.	During hospitalization, up to 24 hours post surgery
Secondary	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.	Within 1 week after hospital discharge
Secondary	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.	Within 1 week after hospital discharge
Secondary	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.	At 1 postoperative hour and at 3 postoperative hours
Secondary	Antiemetic medications	The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours	During hospitalization, up to 24 hours post surgery
Secondary	Hospital length of stay	Using the hospital admission and discharge dates & times; this will be compared between the two groups.	From the date and time of admission to the date and time of discharge, assessed as 24-48 hours