Pre-op Cognitive Behavior Therapy to Decrease Chronic Post-Surgical Pain in TKA

Study Overview
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Brief Summary
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A significant number of patients develop chronic post-surgical pain (CPSP) following knee replacement surgery. Proposed is the testing of a novel computer-assisted behavioral intervention integrating motivational interviewing in the 4 weeks prior to surgery to address the risk factors for CPSP, with the expectation that severity of post-op pain and the incidence of CPSP will be reduced.

Detailed Description
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A significant number of patients develop chronic post-surgical pain following knee joint replacement surgery, and the risk factors for this problematic outcome have been identified. Proposed is the development and preliminary efficacy testing of a novel computer-assisted cognitive behavioral intervention integrating motivational interviewing delivered in the four weeks prior to surgery to address these risk factors, with the expectation that both the severity of post-operative pain and the subsequent incidence of chronic post-surgical pain will be reduced. In that chronic post-surgical pain brings with it diminished functionality and quality of life, ongoing opioid use, and direct patient costs, it is critical that interventions aimed at mitigating its development are implemented and evaluated in the clinical setting. In a sample of adults over the age of 21 with chronic pain undergoing a planned TKA, the objectives of this randomized clinical trial are to: Add a motivational interviewing component to a validated computer-assisted CBT intervention for chronic pain (painTRAINER) to encourage opioid tapering, if applicable, and program adherence in the 4 weeks prior to surgery in patients scheduled to undergo a TKA. Describe the efficacy of the 4-week targeted pre-operative CBT intervention in 45 TKA patients to decrease preoperative chronic pain severity, preoperative opioid consumption, and symptoms of depression, anxiety and pain catastrophizing prior to surgery in comparison to 45 TKA patients randomized to treatment-as-usual. Describe the effects of a 4-week targeted pre-operative CBT intervention in 45 TKA patients on 48hr post-operative pain severity, and 3- and 6-month rates of CPSP in comparison to 45 TKA patients randomized to treatment-as-usual.

Official Title
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Pre-op CBT to Reduce the Risk for Development of Chronic Post-surgical Pain in Patients Undergoing Total Knee Arthroplasty

Conditions
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Chronic Post-Surgical Pain

Intervention / Treatment
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* Behavioral: Computer-Assisted Preoperative CBT Intervention (PAINTrainer)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, age > 21 years Chronic non-malignant pain of at least 3 months duration Morphine equivalent daily dose (MEDD) > 40 milligrams for at least 3 months Able to enroll at least 4 weeks prior to planned surgery Able to speak, read and comprehend in English at the 6th grade or higher proficiency Exclusion Criteria: Pain of malignant origin Current or past history of opioid use disorder (including those on medication-assisted therapy) Revision of TKA Comorbid CNS disease such as dementia, HIV, psychosis, poorly controlled bipolar disorder or any condition interfering with informed consent

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized clinical trial is proposed to evaluate the efficacy of the novel computer-assisted preoperative CBT with integrating motivational interviewing intervention to affect acute and chronic post-operative pain outcomes. Specifically, 90 adult patients over the age of 21 meeting study inclusion criteria and preparing to undergo TKA at the Department of Orthopedic Surgery at Penn Presbyterian Medical Center, Penn Medicine University City, Penn Medicine Radnor, and Pennsylvania Hospital will be randomized to either receive the computer-assisted preoperative CBT intervention (n=45) or treatment-as-usual (control, n=45).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Computer-Assisted Preoperative CBT Intervention<br>Patients will receive the computer-assisted preoperative CBT intervention (n=75). A particularly promising internet-based CBT pain program for the population of interest, PAINTrainer, demonstrated improved pain, function, coping and global health in patients with chronic knee arthritic pain in comparison to an internet education control, with benefits persisting for up to 52 weeks. In addition to the PAINTrainer, there will be an integration of a motivational interviewing (MI) intervention delivered by a trained coach across the sessions about (1) the benefits of opioid tapering for post-operative pain control, (2) approaches for safely tapering, (3) identifying and managing withdrawal symptoms patients may experience. | Behavioral: Computer-Assisted Preoperative CBT Intervention (PAINTrainer)<br>* Subjects will be asked to complete eight (8) 30- to 45-minute educational sessions during the 4 weeks prior to your surgery. In addition to the computer based training sessions, there is a motivational interviewing component that requires subjects to meet with a member of the study team weekly for a total of four (4) 30- to 45-minute meetings to help manage opioid medication use. It is expected that subject participation in this arm of the study will be a total of 12 hours over the course of the entire study.<br>|
| No Intervention: Treatment-as-usual (control)<br>Patients scheduled to undergo total joint arthroplasty at the study site are automatically enrolled in a mandatory 4-hour education class delivered by a nurse educator or physical therapist. Utilizing an in-person Powerpoint presentation format, patients are informed about pre-habilitation exercises to do prior to surgery; what to expect the day of surgery; the multimodal analgesia protocol used in the perioperative period; options for anesthesia and analgesia; and the expectation of physical therapy after surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Chronic Pain Severity | The severity of preoperative chronic pain will be evaluated with the Brief Pain Inventory (BPI), along two dimensions: intensity and interference. Pain intensity is rated on a 0 (no pain) to 10 (worst pain imaginable) scale as the worst in the past 24 hours, least in the past 24 hours, average pain and current pain. Pain interference is measured in 7 areas: general activity, mood, walking ability, work, sleep, enjoyment of life and relationships on a 0 (no interference) to 10 (interferes completely) scale. The composite mean of these scores are used as a pain interference score. BPI scores will be collected at baseline and compared to those collected just prior to surgery and at 3- and 6-month follow-up. | baseline; prior to surgery; 3-months; 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Opioid Use | Preoperative opioid use, if applicable, will be measured by converting to morphine equivalent daily dose (MEDD) at baseline and prior to surgery if the patients are still taking opioids. | baseline; prior to surgery | 
| Post-operative Opioid Use | Post-operative opioid use will be measured, if applicable, by converting to morphine equivalent daily dose (MEDD) at 48 hours post-operatively and 3- and 6-months follow up if the patients are still taking opioids. | 48 hours post-operatively; 3-months; 6-months | 
| Pre-Op Depression | To measure symptoms of depression, PROMIS® (Patient-Reported Outcomes Measurement Information System) person-centered measures will be utilized at baseline and pre-operation. | baseline; pre-operation | 
| Post-Op Depression | To measure symptoms of depression, the PROMIS® (Patient-Reported Outcomes Measurement Information System) person-centered measures will be utilized at 3- and 6-months post-operation. | 3-months; 6-months | 
| Pre-Op Anxiety | To measure symptoms of anxiety, the PROMIS® (Patient-Reported Outcomes Measurement Information System) person-centered measures will be utilized at baseline and pre-operation. | baseline; pre-operation | 
| Post-Op Anxiety | To measure symptoms of anxiety, the PROMIS® (Patient-Reported Outcomes Measurement Information System) person-centered measures will be utilized at 3 and 6 months post-operation. | 3-months; 6-months | 
| Pre-Op Catastrophizing | Pain catastrophizing will be measured by the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). It is broken into three subscales (magnification, rumination, and helplessness); results from the initial development and validation studies indicate that the PCS is a reliable and valid measurement tool for catastrophizing in clinical and non-clinical populations. PCS will be completed at baseline and prior to surgery. | baseline; pre-operation | 
| Post-Op Pain Severity | Severity of post-operative pain will be operationalized as (1) responses on a visual analogue pain scale (VAS) and (2) consumption of opioid analgesic medications during the first 48 hours following surgery. The VAS ranges from 0 (no pain) to 10 (worst pain imaginable), and pain scores are collected every 4 hours as part of routine practice. Pain ratings will be graphed over time and area under the curve calculated. Dose of opioid analgesics consumed during this period (24hr increments and total) will be abstracted from the electronic health record and converted into MEDD for analysis. | 48 hours post-operatively | 
| Chronic Post-Surgical Pain | To evaluate for the presence of CPSP, subjects will be asked at 3- and 6-months if they have pain in the surgical site that developed or increased in intensity following the surgery utilizing a checklist based upon the IASP definition of CPSP (Appendix). If they respond affirmatively, BPI pain scores will be collected to assess the intensity and interference associated with the CPSP. In addition, subjects will be asked if they are continuing to use opioids at these timepoints, and if so, daily MEDD calculated for analysis. | 3-months; 6-months | 
| Post-operative chronic pain intensity | The severity of post-operative chronic pain will be evaluated with the Brief Pain Inventory (BPI), along two dimensions: intensity and interference. Pain intensity is rated on a 0 (no pain) to 10 (worst pain imaginable) scale as the worst in the past 24 hours, least in the past 24 hours, average pain and current pain. Pain interference is measured in 7 areas: general activity, mood, walking ability, work, sleep, enjoyment of life and relationships on a 0 (no interference) to 10 (interferes completely) scale. The composite mean of these scores are used as a pain interference score. BPI scores will be collected at 3- and 6-month follow-up. | 3-months; 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPSP, Chronic Post-Surgical Pain, Cognitive Behavioral Therapy, Total Knee Arthroplasty, Motivational Interviewing, Opioid Taper