Meditation and Opioid Consumption in Total Joint Replacement Patients Undergo Primary Total Hip and Knee Replacement

NCT05669066 | Completed

• 1 other identifier: 2017P000180
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to look at whether meditation techniques can help reduce pain and opioid use after surgery.

Conditions

Arthropathy of Knee; Osteo Arthritis Knee; Osteonecrosis; Meditation; Knee Osteoarthritis; Knee Disease; Knee Injuries; Opioid Use; Opioid Dependence; Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• Post-operative pain

  visual analog scale (VAS) pain score. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. A higher score (closer to 10mm) is worse pain and a worse outcome.

  12 months

• Narcotic consumption

  Measuring the amount of opioids taken

  12 months

Secondary Outcomes (6)

• Length of stay

  Recorded at time of discharge (up to 4 days post-operatively)

• Discharge to extended care facilities

  Recorded at time of discharge (up to 5 days post-operatively)

• Hospital readmission

  90 days post-operatively

• PROMIS mental health score

  90 days post-operatively

• PROMIS physical health score

  90 days post-operatively

Study Arms (2)

Control

NO INTERVENTION

This group will undergo a standardized conventional intra-operative and postoperative analgesia regimen. Anesthetic type and postoperative analgesia will be standardized.

Mindful meditation

EXPERIMENTAL

Start the MM program 2 weeks preoperatively and continue for 30 days post operatively. Study subjects will meet with the meditation instructor for 30 minutes once, 2 weeks prior to surgery, and daily during hospital admission following total joint replacement (TJR). Throughout the intervention period, subjects will be asked to practice daily 15 minutes twice a day, and record their daily meditation experience. Upon discharge from hospital, subjects will receive telephone follow up sessions with the research assistant weekly until 30 days have elapsed. Subjects will be required to show compliance by recording their daily meditation experience in the Daily Meditation Diary (Post-op). At the end of the meditation intervention period, subjects will be asked to provide their feedback in the Patient Satisfaction Survey. Will undergo a standardized, conventional intra-operative postoperative analgesia regimen in addition to the meditation intervention. Anesthetic type will be standardized

Behavioral: Mindful meditation

Interventions

Mindful meditation BEHAVIORAL

Adding mindful meditation to pre- and post-operative care for patients who are having a TKA

Also known as: meditation, Isha Kriya meditation, Sadhguru meditation

Mindful meditation

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, ages 18-89 years
• Narcotic naive patients ("Narcotic naïve" for the purpose of this study will be no history of narcotic tolerance prior to surgery, defined by the FDA as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer)
• Scheduled for primary total knee replacement for osteoarthritis
• Willing to sign informed consent form

You may not qualify if:

• Surgery to be performed for other disease entities (e.g., inflammatory arthritis, post septic arthritis, posttraumatic arthritis or acute fracture)
• History of narcotic tolerance prior to surgery (defined by the FDA as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer)
• Currently taking non-narcotic analgesics other than acetaminophen and non-steroidal anti-inflammatory medications (e.g. Tramadol)
• History of pain syndromes (e.g., fibromyalgia, complex regional pain syndrome, chronic low back pain)
• Dementia or other disorder of cognitive function that precludes study consent and/or participation in the MM program
• In investigator's opinion, unable to complete study tasks over 12-month follow-up period

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (13)

• Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.

  PMID: 22786464 BACKGROUND

• Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR. Characteristics of opioid prescriptions in 2009. JAMA. 2011 Apr 6;305(13):1299-301. doi: 10.1001/jama.2011.401. No abstract available.

  PMID: 21467282 BACKGROUND

• Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Nelson AE, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of hip symptoms and radiographic and symptomatic hip osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2009 Apr;36(4):809-15. doi: 10.3899/jrheum.080677. Epub 2009 Mar 13.

  PMID: 19286855 BACKGROUND

• Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.

  PMID: 17216685 BACKGROUND

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 BACKGROUND

• Young AC, Buvanendran A. Pain management for total hip arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):13-21. doi: 10.3113/jsoa.2014.0013.

  PMID: 24641893 BACKGROUND

• Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.

  PMID: 17823012 BACKGROUND

• Halawi MJ, Vovos TJ, Green CL, Wellman SS, Attarian DE, Bolognesi MP. Opioid-Based Analgesia: Impact on Total Joint Arthroplasty. J Arthroplasty. 2015 Dec;30(12):2360-3. doi: 10.1016/j.arth.2015.06.046. Epub 2015 Jul 2.

  PMID: 26220104 BACKGROUND

• Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.

  PMID: 26871536 BACKGROUND

• Simkin DR, Black NB. Meditation and mindfulness in clinical practice. Child Adolesc Psychiatr Clin N Am. 2014 Jul;23(3):487-534. doi: 10.1016/j.chc.2014.03.002.

  PMID: 24975623 BACKGROUND

• Rosenzweig S, Greeson JM, Reibel DK, Green JS, Jasser SA, Beasley D. Mindfulness-based stress reduction for chronic pain conditions: variation in treatment outcomes and role of home meditation practice. J Psychosom Res. 2010 Jan;68(1):29-36. doi: 10.1016/j.jpsychores.2009.03.010.

  PMID: 20004298 BACKGROUND

• Rangasamy V, Thampi Susheela A, Mueller A, F H Chang T, Sadhasivam S, Subramaniam B. The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. F1000Res. 2019 Mar 26;8:335. doi: 10.12688/f1000research.18446.1. eCollection 2019.

  PMID: 32665843 BACKGROUND

• Packiasabapathy S, Susheela AT, Mueller A, Patxot M, Gasangwa DV, O'Gara B, Shaefi S, Marcantonio ER, Yeh GY, Subramaniam B. Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial. Trials. 2019 Jan 11;20(1):39. doi: 10.1186/s13063-018-3103-8.

  PMID: 30635064 BACKGROUND

MeSH Terms

Conditions

Osteonecrosis; Osteoarthritis, Knee; Knee Injuries; Opioid-Related Disorders

Interventions

Mindfulness; Meditation

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy

Study Officials

• Jacob Drew, MD

  Beth Israel Deaconess Medical Center 330 Brookline Ave Boston, MA 02215

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedic Surgery

Model Details: Patients were randomized to 2 groups. The Meditation group or the Control group. The meditation group was asked to meditate 2 times a day, for 2 weeks preoperatively and for 30 days post operatively

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: December 30, 2022
• Study Start: July 10, 2017
• Primary Completion: December 3, 2021
• Study Completion: December 16, 2021
• Last Updated: December 30, 2022

Record last verified: 2022-12

Locations

US (1)