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Completed

NCT Number: NCT05669066

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

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

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful meditation

Behavioral

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

Other names: meditation, Isha Kriya meditation, Sadhguru meditation

Primary outcomes

  1. 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.

  2. Narcotic consumption

    Time frame: 12 months

    Measuring the amount of opioids taken

Secondary outcomes

  1. 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

  2. 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

  3. Hospital readmission

    Time frame: 90 days post-operatively

    Recording whether or not the patient was readmitted to the hospital

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

The Effect of Mindful Meditation on Opioid Consumption in Patients Who Undergo Primary Total Hip and Knee Replacement

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2022
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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