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

Not Applicable

Completed

• Conditions: Arthropathy of Knee; Knee Injuries; Knee Osteoarthritis; Meditation; Osteo Arthritis Knee; Osteonecrosis; Opioid Dependence; Opioid Use Disorder; Knee Disease; Opioid Use
• Interventions: Behavioral: Mindful meditation

• Registration Number: NCT05669066
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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

Detailed Description

Background: The Center for Disease Control identified prescription drug abuse as one of the top 5 current health threats in the US. Orthopedic Surgeons rank among the top 3 prescribers of opioid analgesics. Opioids are commonly used following total knee arthroplasty. Peri- operative protocols have been developed to reduce opioid intake however complications related to opioid analgesics remain problematic resulting in increased morbidity and mortality. There is a pressing need for non-narcotic adjuncts that can minimize /eliminate the use of opioids following elective total knee arthroplasty (TKA). Mind-body techniques including mindful medication (MM) have been demonstrated to reduce pain in acute and chronic disease states.

Purpose: To determine whether mindful meditation, in conjunction with standard analgesic protocols, can impact opioid consumption, pain and function following elective primary TKA.

Methods: a prospective, randomized control trial was conducted in patients aged 18-99 with degenerative joint disease of the knee presenting for primary TKA. Controls received standard perioperative analgesia. In additional to standard analgesia, study patients performed Isha-Krya meditation peri-operatively for 2 weeks followed by 4 weeks post operatively. Outcome measures: opioid consumption, time to discontinue opioids, Pain by Visual Analog Score (VAS), Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) Global Health Short Form, Knee injury and Osteoarthritis Outcome Score (KOOS)

Study Timeline

• Study Start: 2017-07-10
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-16
• Study First Submitted: 2022-06-08
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-29
• Last Update Submitted: 2022-12-29
• Study First Posted: 2022-12-30
• Last Update Posted: 2022-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindful meditation	Mindful meditation	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

Primary Outcome Measures

Name	Time	Method
Post-operative pain	12 months	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.
Narcotic consumption	12 months	Measuring the amount of opioids taken

Secondary Outcome Measures

Name	Time	Method
PROMIS mental health score	90 days post-operatively	PROMIS mental health survey. The measures are generic, rather than disease-specific, and use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. It is a survey of 10 questions which gives a physical health and mental health score. The raw global health mental score (4-20) is converted to a mental health T score (16.2-67.7). The higher the score, the better the health outcome.
Length of stay	Recorded at time of discharge (up to 4 days post-operatively)	Monitoring how long the patient was in the hospital
Discharge to extended care facilities	Recorded at time of discharge (up to 5 days post-operatively)	Recording where the patient was discharged too
Hospital readmission	90 days post-operatively	Recording whether or not the patient was readmitted to the hospital
PROMIS physical health score	90 days post-operatively	PROMIS physical health survey. The measures are generic, rather than disease-specific, and use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. It is a survey of 10 questions which gives a physical health and mental health score. The raw global health physical score (4-20) is converted to a physical health T score (16.2-67.7). The higher the score, the better the health outcome.
KOOS Jr Score	90 days post-operatively	KOOS JR survey. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States