Preoperative Acupuncture for Total Knee or Hip Arthroplasty
NCT ID: NCT06099223
Last Updated: 2025-03-26
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-03-21
Study Completion Date
2023-05-03
Brief Summary
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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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Detailed Description
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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.
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
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Knee Arthropathy
Hip Arthropathy
Anxiety
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Single-center, prospective, unblinded, randomized controlled clinical trial
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Acupuncture
Preoperative acupuncture
Group Type
EXPERIMENTAL
Acupuncture needles
Intervention Type
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.
Control
No acupuncture
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
DEVICE
Other Intervention Names
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DBC™ Detox-5 Acupuncture Needles (SKU: DTX.20X13) and ure needles o 1) SEIRIN J-Type Acupuncture Needles (SKU: SJ.18X30)
Eligibility Criteria
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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
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hartford Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Pranjali P Kainkaryam, MD
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Bone and Joint Institute- Hartford Hospital
Hartford, Connecticut, United States
Site Status
Countries
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United States
References
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RESULT
Karst M, Winterhalter M, Munte S, Francki B, Hondronikos A, Eckardt A, Hoy L, Buhck H, Bernateck M, Fink M. Auricular acupuncture for dental anxiety: a randomized controlled trial. Anesth Analg. 2007 Feb;104(2):295-300. doi: 10.1213/01.ane.0000242531.12722.fd.
Reference Type
RESULT
Kainkaryam P, Vincze S, Takata E, Secor E, Panza G, Walker A, Gallagher G, Bergner A, Finkel J, Kumar M, Witmer D, Shekhman M, Nagarkatti D. Open-Label Randomized Clinical Trial to Assess the Effects of Preoperative Acupuncture in High Anxiety Patients Undergoing Total Knee or Hip Arthroplasty. J Integr Complement Med. 2025 Feb;31(2):174-182. doi: 10.1089/jicm.2024.0314. Epub 2024 Oct 9.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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HHC-2021-0348
Identifier Type: -
Identifier Source: org_study_id
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