Knee Arthropathy(Acupuncture)NCT06099223
Preoperative Acupuncture for Total Knee or Hip Arthroplasty
A study testing Acupuncture needles in people with Knee Arthropathy and Hip Arthropathy, run by Hartford Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Arthropathy, Hip Arthropathy, Anxiety
- What is being tested?
- Acupuncture needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 3 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bone and Joint Institute- Hartford Hospital
Hartford, Connecticut, 06106
About this study
Official title: Open-Label Randomized Controlled Trial to Assess Preoperative Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty
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.
Read the 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
- Being tested
- Acupuncture needles
- Keywords
- Acupuncture, Total Knee Arthroplasty, Total hip arthroplasty, Anxiety, Pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture needlesDevice
Also called DBC™ Detox-5 Acupuncture Needles (SKU: DTX.20X13) and ure needles o 1) SEIRIN J-Type Acupuncture Needles (SKU: SJ.18X30)
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Preoperative acupuncture Receives: Device: Acupuncture needles |
| Control | No intervention | No acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Total mean pain in the first 3 postoperative hours
Secondary outcomes (17)
Patient Satisfaction With Acupuncture Procedure
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.
Measured: Within 1 week after hospital discharge
Preoperative Pain
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.
Measured: Prior to acupuncture and 30 minutes after acupuncture
Opioid Consumption
Postoperative opioid consumption to be converted into morphine milliequivalents (MMEs) and compared between the two groups for up to 24 hours post surgery.
Measured: During hospitalization, up to 24 hours post surgery
Midazolam Use as Anxiolytic Medications
The dose of Midazolam as an anxiolytic medication that was given at any time throughout hospitalization up to 24 postoperative hours.
Measured: During hospitalization, up to 24 hours post surgery
Patient Satisfaction Scale With Overall Care
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.
Measured: Within 1 week after hospital discharge
Occurrence of Nausea and Vomiting at First 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.
Measured: At 1 postoperative hour
Antiemetic Medications
The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours
Measured: During hospitalization, up to 24 hours post surgery
Hospital Length of Stay
Using the hospital admission and discharge dates \& times; this will be compared between the two groups.
Measured: From the date and time of admission to the date and time of discharge, assessed as 24-48 hours
Postoperative Pain Upon Arrival to the PACU
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.
Measured: Postoperative pain at time of PACU arrival
Postoperative Pain at 1 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.
Measured: At the first postoperative hour
Postoperative Pain After 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 pain scores after three postoperative hours between groups.
Measured: After three postoperative hours
Number of Participants That Received Midazolam Dose >2mg
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.
Measured: During hospitalization up to 24 postoperative hours
Patient's Satisfaction With Pain Management
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.
Measured: Within 1 week after hospital discharge
Patient's Satisfaction With Anxiety Management
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.
Measured: Within 1 week after hospital discharge
Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries
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.
Measured: Within 1 week after hospital discharge
Occurrence of Nausea and Vomiting After 3 Postoperative Hours
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.
Measured: After 3 postoperative hours
Postoperative Pain in the First 3 Postoperative Hours (Group X Time)
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)
Measured: Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start21 Mar 2022
- Primary completion3 Apr 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, unblinded, randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pranjali P Kainkaryam, MD, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099223
- Sponsor's protocol ID
- HHC-2021-0348
- Acronym
- (Acupuncture)
- Status last verified
- Mar 2025
- First submitted
- 19 Oct 2023
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chernyak GV, Sessler DI. Perioperative acupuncture and related techniques. Anesthesiology. 2005 May;102(5):1031-49; quiz 1077-8. doi: 10.1097/00000542-200505000-00024.
PubMed 15851892Lu DP, Lu GP. An Historical Review and Perspective on the Impact of Acupuncture on U.S. Medicine and Society. Med Acupunct. 2013 Oct;25(5):311-316. doi: 10.1089/acu.2012.0921.
PubMed 24761180Crespin DJ, Griffin KH, Johnson JR, Miller C, Finch MD, Rivard RL, Anseth S, Dusek JA. Acupuncture provides short-term pain relief for patients in a total joint replacement program. Pain Med. 2015 Jun;16(6):1195-203. doi: 10.1111/pme.12685. Epub 2015 Jan 13.
PubMed 25586769Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015.
PubMed 11506105Lao L, Bergman S, Hamilton GR, Langenberg P, Berman B. Evaluation of acupuncture for pain control after oral surgery: a placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 1999 May;125(5):567-72. doi: 10.1001/archotol.125.5.567.
PubMed 10326816Mejuto-Vazquez MJ, Salom-Moreno J, Ortega-Santiago R, Truyols-Dominguez S, Fernandez-de-Las-Penas C. Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):252-60. doi: 10.2519/jospt.2014.5108. Epub 2014 Feb 25.
PubMed 24568260Mikashima Y, Takagi T, Tomatsu T, Horikoshi M, Ikari K, Momohara S. Efficacy of acupuncture during post-acute phase of rehabilitation after total knee arthroplasty. J Tradit Chin Med. 2012 Dec;32(4):545-8. doi: 10.1016/s0254-6272(13)60068-0.
PubMed 23427386Tsang RC, Tsang PL, Ko CY, Kong BC, Lee WY, Yip HT. Effects of acupuncture and sham acupuncture in addition to physiotherapy in patients undergoing bilateral total knee arthroplasty--a randomized controlled trial. Clin Rehabil. 2007 Aug;21(8):719-28. doi: 10.1177/0269215507077362.
PubMed 17846072Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Pain. 2005 Apr;114(3):320-327. doi: 10.1016/j.pain.2004.08.021.
PubMed 15777857Usichenko TI, Lehmann Ch, Ernst E. Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials. Anaesthesia. 2008 Dec;63(12):1343-8. doi: 10.1111/j.1365-2044.2008.05632.x.
PubMed 19032304Zhang Y, Zhang L, Lu M. [Acupuncture combined with femoral nerve block for postoperative analgesia after total knee arthroplasty and functional rehabilitation: a randomized controlled trial]. Zhongguo Zhen Jiu. 2018 Mar 12;38(3):251-5. doi: 10.13703/j.0255-2930.2018.03.006. Chinese.
PubMed 29701041Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.
PubMed 25542191Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2.
PubMed 25254059Usichenko TI, Dinse M, Lysenyuk VP, Wendt M, Pavlovic D, Lehmann C. Auricular acupuncture reduces intraoperative fentanyl requirement during hip arthroplasty--a randomized double-blinded study. Acupunct Electrother Res. 2006;31(3-4):213-21. doi: 10.3727/036012906815844265.
PubMed 17608061Wetzel B, Pavlovic D, Kuse R, Gibb A, Merk H, Lehmann C, Wendt M, Usichenko TI. The effect of auricular acupuncture on fentanyl requirement during hip arthroplasty: a randomized controlled trial. Clin J Pain. 2011 Mar-Apr;27(3):262-7. doi: 10.1097/AJP.0b013e3181fd516c.
PubMed 21346689
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Randomized Controlled Trial to Assess Preoperative Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06099223
- Acronym / sponsor ID
- (Acupuncture) / HHC-2021-0348
- Conditions
- Knee Arthropathy, Hip Arthropathy, Anxiety
- Keywords
- Acupuncture, Total Knee Arthroplasty, Total hip arthroplasty, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, prospective, unblinded, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: Acupuncture needlesPreoperative acupuncture |
| Control | No intervention | –No acupuncture |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture needlesAlso: DBC™ Detox-5 Acupuncture Needles (SKU: DTX.20X13) and ure needles o 1) SEIRIN J-Type Acupuncture Needles (SKU: SJ.18X30)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. | Device | Acupuncture |
Primary outcome
Perioperative Anxiety
Time frame: Prior to acupuncture and 30 minutes after acupuncture
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.
Postoperative Pain in the First 3 Postoperative Hours
Time frame: 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.
17 secondary outcomes
Patient Satisfaction With Acupuncture Procedure
Time frame: Within 1 week after hospital discharge
Preoperative Pain
Time frame: Prior to acupuncture and 30 minutes after acupuncture
Opioid Consumption
Time frame: During hospitalization, up to 24 hours post surgery
Midazolam Use as Anxiolytic Medications
Time frame: During hospitalization, up to 24 hours post surgery
Patient Satisfaction Scale With Overall Care
Time frame: Within 1 week after hospital discharge
Occurrence of Nausea and Vomiting at First Postoperative Hour
Time frame: At 1 postoperative hour
Antiemetic Medications
Time frame: During hospitalization, up to 24 hours post surgery
Hospital Length of Stay
Time frame: From the date and time of admission to the date and time of discharge, assessed as 24-48 hours
Postoperative Pain Upon Arrival to the PACU
Time frame: Postoperative pain at time of PACU arrival
Postoperative Pain at 1 Postoperative Hour
Time frame: At the first postoperative hour
Postoperative Pain After 3 Postoperative Hours
Time frame: After three postoperative hours
Number of Participants That Received Midazolam Dose >2mg
Time frame: During hospitalization up to 24 postoperative hours
Patient's Satisfaction With Pain Management
Time frame: Within 1 week after hospital discharge
Patient's Satisfaction With Anxiety Management
Time frame: Within 1 week after hospital discharge
Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries
Time frame: Within 1 week after hospital discharge
Occurrence of Nausea and Vomiting After 3 Postoperative Hours
Time frame: After 3 postoperative hours
Postoperative Pain in the First 3 Postoperative Hours (Group X Time)
Time frame: Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15851892Chernyak GV, Sessler DI. Perioperative acupuncture and related techniques. Anesthesiology. 2005 May;102(5):1031-49; quiz 1077-8. doi: 10.1097/00000542-200505000-00024.
- Background: PubMed 24761180Lu DP, Lu GP. An Historical Review and Perspective on the Impact of Acupuncture on U.S. Medicine and Society. Med Acupunct. 2013 Oct;25(5):311-316. doi: 10.1089/acu.2012.0921.
- Background: PubMed 25586769Crespin DJ, Griffin KH, Johnson JR, Miller C, Finch MD, Rivard RL, Anseth S, Dusek JA. Acupuncture provides short-term pain relief for patients in a total joint replacement program. Pain Med. 2015 Jun;16(6):1195-203. doi: 10.1111/pme.12685. Epub 2015 Jan 13.
- Background: PubMed 11506105Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015.
- Background: PubMed 10326816Lao L, Bergman S, Hamilton GR, Langenberg P, Berman B. Evaluation of acupuncture for pain control after oral surgery: a placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 1999 May;125(5):567-72. doi: 10.1001/archotol.125.5.567.
- Background: PubMed 24568260Mejuto-Vazquez MJ, Salom-Moreno J, Ortega-Santiago R, Truyols-Dominguez S, Fernandez-de-Las-Penas C. Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):252-60. doi: 10.2519/jospt.2014.5108. Epub 2014 Feb 25.
- Background: PubMed 23427386Mikashima Y, Takagi T, Tomatsu T, Horikoshi M, Ikari K, Momohara S. Efficacy of acupuncture during post-acute phase of rehabilitation after total knee arthroplasty. J Tradit Chin Med. 2012 Dec;32(4):545-8. doi: 10.1016/s0254-6272(13)60068-0.
- Background: PubMed 17846072Tsang RC, Tsang PL, Ko CY, Kong BC, Lee WY, Yip HT. Effects of acupuncture and sham acupuncture in addition to physiotherapy in patients undergoing bilateral total knee arthroplasty--a randomized controlled trial. Clin Rehabil. 2007 Aug;21(8):719-28. doi: 10.1177/0269215507077362.
- Background: PubMed 15777857Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Pain. 2005 Apr;114(3):320-327. doi: 10.1016/j.pain.2004.08.021.
- Background: PubMed 19032304Usichenko TI, Lehmann Ch, Ernst E. Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials. Anaesthesia. 2008 Dec;63(12):1343-8. doi: 10.1111/j.1365-2044.2008.05632.x.
- Background: PubMed 29701041Zhang Y, Zhang L, Lu M. [Acupuncture combined with femoral nerve block for postoperative analgesia after total knee arthroplasty and functional rehabilitation: a randomized controlled trial]. Zhongguo Zhen Jiu. 2018 Mar 12;38(3):251-5. doi: 10.13703/j.0255-2930.2018.03.006. Chinese.
- Background: PubMed 25542191Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture needles in people with Knee Arthropathy and Hip Arthropathy, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Anxiety (time frame: Prior to acupuncture and 30 minutes after acupuncture). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06099223, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.