Meditation and Opioid Consumption in Total Joint Replacement Patients Undergo Primary Total Hip and Knee Replacement
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| ClinicalTrials.gov Identifier: NCT05669066 |
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Recruitment Status :
Completed
First Posted : December 30, 2022
Last Update Posted : December 30, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Arthropathy of Knee Osteo Arthritis Knee Osteonecrosis Meditation Knee Osteoarthritis Knee Disease Knee Injuries Opioid Use Opioid Dependence Opioid Use Disorder | Behavioral: Mindful meditation | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 29 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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 |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Effect of Mindful Meditation on Opioid Consumption in Patients Who Undergo Primary Total Hip and Knee Replacement |
| Actual Study Start Date : | July 10, 2017 |
| Actual Primary Completion Date : | December 3, 2021 |
| Actual Study Completion Date : | December 16, 2021 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control
This group will undergo a standardized conventional intra-operative and postoperative analgesia regimen. Anesthetic type and postoperative analgesia will be standardized.
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Experimental: 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
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Behavioral: Mindful meditation
Adding mindful meditation to pre- and post-operative care for patients who are having a TKA
Other Names:
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- Post-operative pain [ Time Frame: 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 [ Time Frame: 12 months ]Measuring the amount of opioids taken
- Length of stay [ Time Frame: 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 [ Time Frame: Recorded at time of discharge (up to 5 days post-operatively) ]Recording where the patient was discharged too
- Hospital readmission [ Time Frame: 90 days post-operatively ]Recording whether or not the patient was readmitted to the hospital
- PROMIS mental health score [ Time Frame: 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.
- PROMIS physical health score [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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• 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:
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• 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05669066
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Jacob Drew, MD | Beth Israel Deaconess Medical Center 330 Brookline Ave Boston, MA 02215 |
| Responsible Party: | Jacob Drew, Assistant Professor of Orthopedic Surgery, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT05669066 |
| Other Study ID Numbers: |
2017P000180 |
| First Posted: | December 30, 2022 Key Record Dates |
| Last Update Posted: | December 30, 2022 |
| Last Verified: | December 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Osteoarthritis Osteoarthritis, Knee Osteonecrosis Opioid-Related Disorders Knee Injuries Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Narcotic-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Bone Diseases Necrosis Pathologic Processes Leg Injuries Wounds and Injuries |