Arthropathy of Knee, Knee Disease, Knee Injuries, Knee Osteoarthritis, Meditation, Opioid Dependence, Opioid Use, Opioid Use Disorder, Osteo Arthritis Knee, Osteonecrosis
Conditions
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)
Interventions
BEHAVIORALMindful meditation
Adding mindful meditation to pre- and post-operative care for patients who are having a TKA
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hospital readmission | 90 days post-operatively | Recording whether or not the patient was readmitted to the hospital |
| 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 |
| 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. |
| 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. |
| Discharge to extended care facilities | Recorded at time of discharge (up to 5 days post-operatively) | Recording where the patient was discharged too |
Countries
United States
Outcome results
None listed