Trial Outcomes & Findings for Preoperative Acupuncture for Total Knee or Hip Arthroplasty (NCT NCT06099223)

Last Updated: 2025-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Prior to acupuncture and 30 minutes after acupuncture

Results posted on

2025-03-26

Participant Flow

Participants were recruited based on their high anxiety score (according to the validated Amsterdam Preoperative Anxiety and Information Scale (APAIS-A-T\>10) who are scheduled for elective total knee or hip arthroplasty surgery at Bone and Joint Center from March 2022 to April 2023. The first patient was enrolled in March 21, 2022 and the last patient was enrolled in April 3, 2023.

Of 123 screened patients, 60 met the inclusion criteria and were randomized to treatment. 31 patients declined participation, 26 patients did not meet the eligibility criteria, 5 patients consented but had surgery cancellation, and 1 patient withdrew consent.

Participant milestones

Participant milestones
Measure	Acupuncture Preoperative acupuncture 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.	Control No acupuncture
Overall Study STARTED	30	30
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Acupuncture Preoperative acupuncture 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.	Control No acupuncture
Overall Study Preoperative surveys missed	0	1

Baseline Characteristics

Preoperative Acupuncture for Total Knee or Hip Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupuncture n=30 Participants Preoperative acupuncture 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.	Control n=30 Participants No acupuncture	Total n=60 Participants Total of all reporting groups
Age, Continuous	69.60 Years STANDARD_DEVIATION 9.71 • n=5 Participants	67.63 Years STANDARD_DEVIATION 7.71 • n=7 Participants	68.62 Years STANDARD_DEVIATION 8.75 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Body Mass Index (BMI)	32.16 kg/m2 STANDARD_DEVIATION 5.31 • n=5 Participants	30.44 kg/m2 STANDARD_DEVIATION 5.51 • n=7 Participants	31.30 kg/m2 STANDARD_DEVIATION 5.44 • n=5 Participants
Charlson Comorbidity Index (CCI)	1.0 units on a scale n=5 Participants	0.0 units on a scale n=7 Participants	0.0 units on a scale n=5 Participants
History of mental illness History of mental illnesses	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
History of mental illness Anxiety	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
History of mental illness Bipolar disorder	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
History of mental illness Depression	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
History of acupuncture Yes	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
History of acupuncture No	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Modified Amsterdam Pre-operative Anxiety and Information Scale (APAIS) Score	13.27 units on a scale STANDARD_DEVIATION 2.39 • n=5 Participants	13.90 units on a scale STANDARD_DEVIATION 2.56 • n=7 Participants	13.58 units on a scale STANDARD_DEVIATION 2.48 • n=5 Participants
Preoperative Visual Analogue Scale Score	60.73 units on a scale STANDARD_DEVIATION 21.28 • n=5 Participants	59.66 units on a scale STANDARD_DEVIATION 30.11 • n=7 Participants	60.20 units on a scale STANDARD_DEVIATION 25.77 • n=5 Participants
Surgery type Total Hip Arthroplasty	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Surgery type Total Knee Arthroplasty	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to acupuncture and 30 minutes after acupuncture

Population: Only participants in the acupuncture group (n=30) completed the Visual Analog Scale to reflect the level of anxiety they had before and 30 minutes after receiving the acupuncture procedure.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Perioperative Anxiety	60.73 score on a scale Standard Deviation 21.28	28.90 score on a scale Standard Deviation 21.54

PRIMARY outcome

Timeframe: Total mean pain in the first 3 postoperative hours

Population: Total mean 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.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Postoperative Pain in the First 3 Postoperative Hours	1.93 score on a scale Standard Deviation 1.63	2.79 score on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: Within 1 week after hospital discharge

Patients' satisfaction with acupuncture intervention was assessed in the acupuncture group only using the satisfaction scale of (1-5), where 1 is Extremely satisfied, 2 is Very satisfied, 3 is Somewhat satisfied, 4 is Not very satisfied, and 5 is Not at all satisfied. Each frequency represented the percentage of patients who were satisfied (given a score of 1 or 2 out of 5) with their acupuncture treatment. This assessment was done within a week after discharge, via a phone call.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Patient Satisfaction With Acupuncture Procedure	22 Participants	—

SECONDARY outcome

Timeframe: Prior to acupuncture and 30 minutes after acupuncture

Population: Only participants in the acupuncture group (n=30) completed the Numeric Pain Scale to reflect the level of pain they had before and 30 minutes after receiving the acupuncture procedure.

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.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Preoperative Pain	4.97 score on a scale Standard Deviation 3.01	2.90 score on a scale Standard Deviation 6.62

SECONDARY outcome

Timeframe: During hospitalization, up to 24 hours post surgery

Postoperative opioid consumption to be converted into morphine milliequivalents (MMEs) and compared between the two groups for up to 24 hours post surgery.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Opioid Consumption	45.51 Morphine MilliEquivalent Standard Deviation 30.02	52.46 Morphine MilliEquivalent Standard Deviation 30.92

SECONDARY outcome

Timeframe: During hospitalization, up to 24 hours post surgery

The dose of Midazolam as an anxiolytic medication that was given at any time throughout hospitalization up to 24 postoperative hours.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Midazolam Use as Anxiolytic Medications	3.96 milligrams Standard Deviation 1.73	4.21 milligrams Standard Deviation 1.80

SECONDARY outcome

Timeframe: Within 1 week after hospital discharge

Patients' satisfaction with overall care management was compared using the patient satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied with overall care. Each frequency represents the percentage of patients in each group who have been either satisfied or extremely satisfied (given a score of 9 or 10 out of 10). This assessment was done within a week after discharge, via a phone call.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Patient Satisfaction Scale With Overall Care	21 Participants	24 Participants

SECONDARY outcome

Timeframe: At 1 postoperative hour

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. This scale was used to report the occurrence of nausea (yes/no), with "yes" defined as any number above 0 in the scale, while "no" defined as 0.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Occurrence of Nausea and Vomiting at First Postoperative Hour Yes	0 Participants	4 Participants
Occurrence of Nausea and Vomiting at First Postoperative Hour No	30 Participants	26 Participants

SECONDARY outcome

Timeframe: During hospitalization, up to 24 hours post surgery

The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Antiemetic Medications	0.0 number of doses Interval 0.0 to 1.0	0.0 number of doses Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: From the date and time of admission to the date and time of discharge, assessed as 24-48 hours

Using the hospital admission and discharge dates \& times; this will be compared between the two groups.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Hospital Length of Stay	29.5 hours Interval 27.8 to 31.3	29.0 hours Interval 27.0 to 30.0

SECONDARY outcome

Timeframe: Postoperative pain at time of PACU arrival

Population: Mean pain scores upon arrival to the PACU between the groups

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 pain scores between groups upon arrival to the PACU.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Postoperative Pain Upon Arrival to the PACU	0.47 score on a scale Standard Deviation 1.36	1.38 score on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: At the first postoperative hour

Population: Using the mean of pain scores reported by participants at the first postoperative hour

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 pain scores at the first postoperative hour between groups.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Postoperative Pain at 1 Postoperative Hour	1.67 score on a scale Standard Deviation 2.22	2.45 score on a scale Standard Deviation 3.15

SECONDARY outcome

Timeframe: After three postoperative hours

Population: Using the mean pain scores after three postoperative hours between groups

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 pain scores after three postoperative hours between groups.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Postoperative Pain After 3 Postoperative Hours	3.67 score on a scale Standard Deviation 3.03	4.55 score on a scale Standard Deviation 3.29

SECONDARY outcome

Timeframe: During hospitalization up to 24 postoperative hours

The number of participants who received a dose of midazolam exceeding 2 mg indicated a high level of perioperative anxiety that necessitated pharmacological intervention. The decision to use a dose higher than 2 mg was based on the standard practice of administering 2 mg of midazolam for preoperative regional nerve blocks; any dosage surpassing this amount was specifically intended for anxiety management.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Number of Participants That Received Midazolam Dose >2mg	19 Participants	22 Participants

SECONDARY outcome

Timeframe: Within 1 week after hospital discharge

Population: Each frequency represented the percentage of patients in the group who were satisfied (given a score of 9 or 10 out of 10)

Patients' satisfaction with their postoperative pain management was compared between groups using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. Each frequency represented the percentage of patients in each group who were satisfied (given a score of 9 or 10 out of 10)This assessment was done within a week after discharge, via a phone call.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Patient's Satisfaction With Pain Management	19 Participants	20 Participants

SECONDARY outcome

Timeframe: Within 1 week after hospital discharge

Patients' satisfaction with their perioperative anxiety management was compared between groups using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. Each frequency represented the percentage of patients in each group who were satisfied (given a score of 9 or 10 out of 10). This assessment was done within a week after discharge, via a phone call.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Patient's Satisfaction With Anxiety Management	21 Participants	19 Participants

SECONDARY outcome

Timeframe: Within 1 week after hospital discharge

Patients with acupuncture intervention were assessed for how likely to consider acupuncture for future surgeries using a scale of (1-4), where 1 is Very likely, 2 is Likely, 3 is Maybe, and 4 is Never. Each frequency represented the percentage of patients who were more likely (given a score of 1 or 2 out of 4) to receive acupuncture treatment in a future surgery. This assessment was done within a week after discharge, via a phone call.

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries	25 Participants	—

SECONDARY outcome

Timeframe: After 3 postoperative hours

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Occurrence of Nausea and Vomiting After 3 Postoperative Hours Yes	5 Participants	5 Participants
Occurrence of Nausea and Vomiting After 3 Postoperative Hours No	25 Participants	25 Participants

SECONDARY outcome

Timeframe: Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour

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". To compare mean pain scores between groups, considering all 3 individual time points (at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour)

Outcome measures

Outcome measures
Measure	Preoperative Pre-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety immediately prior to having the acupuncture procedure	Preoperative Post-acupuncture n=30 Participants Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure
Postoperative Pain in the First 3 Postoperative Hours (Group X Time) at arrival to PACU	0.47 score on a scale Standard Deviation 1.36	1.38 score on a scale Standard Deviation 2.83
Postoperative Pain in the First 3 Postoperative Hours (Group X Time) 1hr post-operation	1.67 score on a scale Standard Deviation 2.22	2.45 score on a scale Standard Deviation 3.15
Postoperative Pain in the First 3 Postoperative Hours (Group X Time) 3hr post-operation	3.67 score on a scale Standard Deviation 3.03	4.55 score on a scale Standard Deviation 3.29

Adverse Events

Acupuncture Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acupuncture Group n=30 participants at risk Patients who received the preoperative acupuncture procedure.	Control Group n=30 participants at risk Patients who did not receive the preoperative acupuncture procedure.
Surgical and medical procedures Local bleeding	30.0% 9/30 • Number of events 9 • Adverse events were collected up to 30 postoperative days	0.00% 0/30 • Adverse events were collected up to 30 postoperative days
Surgical and medical procedures Discomfort	3.3% 1/30 • Number of events 1 • Adverse events were collected up to 30 postoperative days	0.00% 0/30 • Adverse events were collected up to 30 postoperative days
Surgical and medical procedures Residual pain	10.0% 3/30 • Number of events 3 • Adverse events were collected up to 30 postoperative days	0.00% 0/30 • Adverse events were collected up to 30 postoperative days

Additional Information

Aseel Walker

Hartford Hospital

Phone: 860-972-1778

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place