Preoperative Acupuncture for Total Knee or Hip Arthroplasty

NCT06099223 | Completed Results FDA Device

• 1 other identifier: HHC-2021-0348
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthropathy; Hip Arthropathy; Anxiety

Keywords

Acupuncture; Total Knee Arthroplasty; Total hip arthroplasty; Anxiety; Pain

Outcome Measures

Primary Outcomes (2)

• Perioperative Anxiety

  Determine the effect of preoperative acupuncture on preoperative anxiety in the acupuncture group using VAS (Visual Analog Scale) which is a 10 centimeters line 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. A higher score means worse as it means high anxiety.

  Prior to acupuncture and 30 minutes after acupuncture

• Postoperative Pain in the First 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 the mean of the total pain in the first 3 postoperative hours between groups.

  Total mean pain in the first 3 postoperative hours

Secondary Outcomes (17)

• Patient Satisfaction With Acupuncture Procedure

  Within 1 week after hospital discharge

• Preoperative Pain

  Prior to acupuncture and 30 minutes after acupuncture

• Opioid Consumption

  During hospitalization, up to 24 hours post surgery

• Midazolam Use as Anxiolytic Medications

  During hospitalization, up to 24 hours post surgery

• Patient Satisfaction Scale With Overall Care

  Within 1 week after hospital discharge

Study Arms (2)

Acupuncture

EXPERIMENTAL

Preoperative acupuncture

Device: Acupuncture needles

Control

NO INTERVENTION

No acupuncture

Interventions

Acupuncture needles 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.

Also known as: DBC™ Detox-5 Acupuncture Needles (SKU: DTX.20X13) and ure needles o 1) SEIRIN J-Type Acupuncture Needles (SKU: SJ.18X30)

Acupuncture

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Bone and Joint Institute- Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (40)

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• 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.

  PMID: 39383026 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The limitation of this study is the open-label aspect could be associated with placebo effects.

Results Point of Contact

• Title: Aseel Walker
• Organization: Hartford Hospital

aseel.walker@hhchealth.org

860-972-1778

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-center, prospective, unblinded, randomized controlled clinical trial

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: March 21, 2022
• Primary Completion: April 3, 2023
• Study Completion: May 3, 2023
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)