An interventional study of Mindful meditation in Arthropathy of Knee, Osteo Arthritis Knee and Osteonecrosis, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-30.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Prevention
The main purpose of this study is to look at whether meditation techniques can help reduce pain and opioid use after surgery.
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)
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 29 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
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Male and female, ages 18-89 years
Exclusion Criteria:
Surgery to be performed for other disease entities (e.g., inflammatory arthritis, post septic arthritis, posttraumatic arthritis or acute fracture)
This group will undergo a standardized conventional intra-operative and postoperative analgesia regimen. Anesthetic type and postoperative analgesia will be standardized.
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
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
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.
Time frame: 12 months
Narcotic consumption
Measuring the amount of opioids taken
Time frame: 12 months
Length of stay
Monitoring how long the patient was in the hospital
Time frame: Recorded at time of discharge (up to 4 days post-operatively)
Discharge to extended care facilities
Recording where the patient was discharged too
Time frame: Recorded at time of discharge (up to 5 days post-operatively)
Hospital readmission
Recording whether or not the patient was readmitted to the hospital
Time frame: 90 days post-operatively
PROMIS mental health score
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.
Time frame: 90 days post-operatively
PROMIS physical health score
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.
Time frame: 90 days post-operatively
KOOS Jr Score
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.
Time frame: 90 days post-operatively
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center