N/A
N=60
Preoperative Acupuncture for Total Knee or Hip Arthroplasty
Knee Arthropathy · Hip Arthropathy · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT06099223 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Perioperative Anxiety — 60.73; 28.90 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture needles (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hartford Hospital
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perioperative Anxiety |
60.73; 28.90 | <0.001 sig |
| PRIMARY Postoperative Pain in the First 3 Postoperative Hours |
1.93; 2.79 | 0.029 sig |
| SECONDARY Patient Satisfaction With Acupuncture Procedure |
22 | — |
| SECONDARY Preoperative Pain |
4.97; 2.90 | <0.001 sig |
| SECONDARY Opioid Consumption |
45.51; 52.46 | 0.38 |
| SECONDARY Midazolam Use as Anxiolytic Medications |
3.96; 4.21 | 0.61 |
| SECONDARY Patient Satisfaction Scale With Overall Care |
21; 24 | 0.37 |
| SECONDARY Occurrence of Nausea and Vomiting at First Postoperative Hour |
0; 4; 30; 26 | 0.11 |
| SECONDARY Antiemetic Medications |
0.0; 0.0 | 0.37 |
| SECONDARY Hospital Length of Stay |
29.5; 29.0 | 0.38 |
| SECONDARY Postoperative Pain Upon Arrival to the PACU |
0.47; 1.38 | 0.087 |
| SECONDARY Postoperative Pain at 1 Postoperative Hour |
1.67; 2.45 | 0.147 |
| SECONDARY Postoperative Pain After 3 Postoperative Hours |
3.67; 4.55 | 0.098 |
| SECONDARY Number of Participants That Received Midazolam Dose >2mg |
19; 22 | 0.41 |
| SECONDARY Patient's Satisfaction With Pain Management |
19; 20 | 0.79 |
| SECONDARY Patient's Satisfaction With Anxiety Management |
21; 19 | 0.58 |
| SECONDARY Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries |
25 | — |
| SECONDARY Occurrence of Nausea and Vomiting After 3 Postoperative Hours |
5; 5; 25; 25 | 1.00 |
| SECONDARY Postoperative Pain in the First 3 Postoperative Hours (Group X Time) |
0.47; 1.38; 1.67; 2.45; 3.67; 4.55 | 0.919 |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT06099223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.