NCT06099223

Preoperative Acupuncture for Total Knee or Hip Arthroplasty

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Knee Arthropathy
• Hip Arthropathy
• Anxiety

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-21
• Primary completion: 2023-04-03
• Completion: 2023-05-03
• First posted: 2023-10-25
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study