Clinical trial NCT06099223: Preoperative Acupuncture for Total Knee or Hip Arthroplasty
Official title: Open-Label Randomized Controlled Trial to Assess Preoperative Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Hip Arthropathy
Anxiety
Keywords: Acupuncture
Total Knee Arthroplasty
Total hip arthroplasty
Anxiety
Pain
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective, unblinded, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

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 \<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.

Primary outcomes:
measure: Perioperative Anxiety
timeFrame: Prior to acupuncture and 30 minutes after acupuncture
measure: Postoperative Pain in the First 3 Postoperative Hours
timeFrame: Total mean pain in the first 3 postoperative hours
Secondary outcomes:
measure: Patient Satisfaction With Acupuncture Procedure
timeFrame: Within 1 week after hospital discharge
measure: Preoperative Pain
timeFrame: Prior to acupuncture and 30 minutes after acupuncture
measure: Opioid Consumption
timeFrame: During hospitalization, up to 24 hours post surgery
measure: Midazolam Use as Anxiolytic Medications
timeFrame: During hospitalization, up to 24 hours post surgery
measure: Patient Satisfaction Scale With Overall Care
timeFrame: Within 1 week after hospital discharge
measure: Occurrence of Nausea and Vomiting at First Postoperative Hour
timeFrame: At 1 postoperative hour
measure: Antiemetic Medications
timeFrame: During hospitalization, up to 24 hours post surgery
measure: Hospital Length of Stay
timeFrame: From the date and time of admission to the date and time of discharge, assessed as 24-48 hours
measure: Postoperative Pain Upon Arrival to the PACU
timeFrame: Postoperative pain at time of PACU arrival
measure: Postoperative Pain at 1 Postoperative Hour
timeFrame: At the first postoperative hour
measure: Postoperative Pain After 3 Postoperative Hours
timeFrame: After three postoperative hours
measure: Number of Participants That Received Midazolam Dose >2mg
timeFrame: During hospitalization up to 24 postoperative hours
measure: Patient's Satisfaction With Pain Management
timeFrame: Within 1 week after hospital discharge
measure: Patient's Satisfaction With Anxiety Management
timeFrame: Within 1 week after hospital discharge
measure: Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries
timeFrame: Within 1 week after hospital discharge
measure: Occurrence of Nausea and Vomiting After 3 Postoperative Hours
timeFrame: After 3 postoperative hours
measure: Postoperative Pain in the First 3 Postoperative Hours (Group X Time)
timeFrame: Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Bone and Joint Institute- Hartford Hospital
state: Connecticut
Study officials:
References:
citation: 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.
citation: Lu 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.
citation: Crespin 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.
citation: Kotani 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.
citation: Lao 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.
citation: Mejuto-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.
citation: Mikashima 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.
citation: Tsang 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.
citation: Usichenko 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.
citation: Usichenko 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.
citation: Zhang 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.
citation: Lewis 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.
citation: Bae 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.
citation: Usichenko 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.
citation: Wetzel 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.
citation: Li M, Xing X, Yao L, Li X, He W, Wang M, Li H, Wang X, Xun Y, Yan P, Lu Z, Zhou B, Yang X, Yang K. Acupuncture for treatment of anxiety, an overview of systematic reviews. Complement Ther Med. 2019 Apr;43:247-252. doi: 10.1016/j.ctim.2019.02.013. Epub 2019 Feb 16.
citation: Ali A, Lindstrand A, Sundberg M, Flivik G. Preoperative Anxiety and Depression Correlate With Dissatisfaction After Total Knee Arthroplasty: A Prospective Longitudinal Cohort Study of 186 Patients, With 4-Year Follow-Up. J Arthroplasty. 2017 Mar;32(3):767-770. doi: 10.1016/j.arth.2016.08.033. Epub 2016 Sep 3.
citation: Ayers DC, Franklin PD, Ploutz-Snyder R, Boisvert CB. Total knee replacement outcome and coexisting physical and emotional illness. Clin Orthop Relat Res. 2005 Nov;440:157-61. doi: 10.1097/01.blo.0000185447.43622.93.
citation: Bachmeier CJ, March LM, Cross MJ, Lapsley HM, Tribe KL, Courtenay BG, Brooks PM; Arthritis Cost and Outcome Project Group. A comparison of outcomes in osteoarthritis patients undergoing total hip and knee replacement surgery. Osteoarthritis Cartilage. 2001 Feb;9(2):137-46. doi: 10.1053/joca.2000.0369.
citation: Blackburn J, Qureshi A, Amirfeyz R, Bannister G. Does preoperative anxiety and depression predict satisfaction after total knee replacement? Knee. 2012 Oct;19(5):522-4. doi: 10.1016/j.knee.2011.07.008. Epub 2011 Aug 16.
citation: Brander V, Gondek S, Martin E, Stulberg SD. Pain and depression influence outcome 5 years after knee replacement surgery. Clin Orthop Relat Res. 2007 Nov;464:21-6. doi: 10.1097/BLO.0b013e318126c032.
citation: Riddle DL, Wade JB, Jiranek WA, Kong X. Preoperative pain catastrophizing predicts pain outcome after knee arthroplasty. Clin Orthop Relat Res. 2010 Mar;468(3):798-806. doi: 10.1007/s11999-009-0963-y. Epub 2009 Jul 8.
citation: Rolfson O, Dahlberg LE, Nilsson JA, Malchau H, Garellick G. Variables determining outcome in total hip replacement surgery. J Bone Joint Surg Br. 2009 Feb;91(2):157-61. doi: 10.1302/0301-620X.91B2.20765.
citation: Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.
citation: Xu J, Twiggs J, Parker D, Negus J. The Association Between Anxiety, Depression, and Locus of Control With Patient Outcomes Following Total Knee Arthroplasty. J Arthroplasty. 2020 Mar;35(3):720-724. doi: 10.1016/j.arth.2019.10.022. Epub 2019 Oct 18.
citation: Yang MMH, Hartley RL, Leung AA, Ronksley PE, Jette N, Casha S, Riva-Cambrin J. Preoperative predictors of poor acute postoperative pain control: a systematic review and meta-analysis. BMJ Open. 2019 Apr 1;9(4):e025091. doi: 10.1136/bmjopen-2018-025091.
citation: Kahlenberg CA, Nwachukwu BU, McLawhorn AS, Cross MB, Cornell CN, Padgett DE. Patient Satisfaction After Total Knee Replacement: A Systematic Review. HSS J. 2018 Jul;14(2):192-201. doi: 10.1007/s11420-018-9614-8. Epub 2018 Jun 5.
citation: Acar HV. Acupuncture and related techniques during perioperative period: A literature review. Complement Ther Med. 2016 Dec;29:48-55. doi: 10.1016/j.ctim.2016.09.013. Epub 2016 Sep 13.
citation: Alattas SA, Smith T, Bhatti M, Wilson-Nunn D, Donell S. Greater pre-operative anxiety, pain and poorer function predict a worse outcome of a total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3403-3410. doi: 10.1007/s00167-016-4314-8. Epub 2016 Oct 12.
citation: Eberhart L, Aust H, Schuster M, Sturm T, Gehling M, Euteneuer F, Rusch D. Preoperative anxiety in adults - a cross-sectional study on specific fears and risk factors. BMC Psychiatry. 2020 Mar 30;20(1):140. doi: 10.1186/s12888-020-02552-w.
citation: Song B, Yang Y, Teng X, Li Y, Bai W, Zhu J. Use of pre-operative anxiety score to determine the precise dose of butorphanol for intra-operative sedation under regional anesthesia: A double-blinded randomized trial. Exp Ther Med. 2019 Nov;18(5):3885-3892. doi: 10.3892/etm.2019.8040. Epub 2019 Sep 23.
citation: Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
citation: Kuzminskaite V, Kaklauskaite J, Petkeviciute J. Incidence and features of preoperative anxiety in patients undergoing elective non-cardiac surgery. Acta Med Litu. 2019;26(1):93-100. doi: 10.6001/actamedica.v26i1.3961.
citation: Stuyt EB, Voyles CA. The National Acupuncture Detoxification Association protocol, auricular acupuncture to support patients with substance abuse and behavioral health disorders: current perspectives. Subst Abuse Rehabil. 2016 Dec 7;7:169-180. doi: 10.2147/SAR.S99161. eCollection 2016.
citation: Furuse N, Shinbara H, Uehara A, Sugawara M, Yamazaki T, Hosaka M, Yamashita H. A Multicenter Prospective Survey of Adverse Events Associated with Acupuncture and Moxibustion in Japan. Med Acupunct. 2017 Jun 1;29(3):155-162. doi: 10.1089/acu.2017.1230.
citation: Zhang J, Shang H, Gao X, Ernst E. Acupuncture-related adverse events: a systematic review of the Chinese literature. Bull World Health Organ. 2010 Dec 1;88(12):915-921C. doi: 10.2471/BLT.10.076737. Epub 2010 Aug 27.
citation: Xu S, Wang L, Cooper E, Zhang M, Manheimer E, Berman B, Shen X, Lao L. Adverse events of acupuncture: a systematic review of case reports. Evid Based Complement Alternat Med. 2013;2013:581203. doi: 10.1155/2013/581203. Epub 2013 Mar 20.
citation: Chen CC, Yang CC, Hu CC, Shih HN, Chang YH, Hsieh PH. Acupuncture for pain relief after total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):31-6. doi: 10.1097/AAP.0000000000000138.
citation: 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.