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

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ClinicalTrials.gov Identifier: NCT04814992
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : August 19, 2021
Sponsor:
Information provided by (Responsible Party):
Peggy Compton, RN, PhD, University of Pennsylvania

Study Description
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Brief Summary:
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 with opioid taper delivered 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.

Condition or disease Intervention/treatment Phase
Chronic Post-Surgical Pain Behavioral: Computer-Assisted Preoperative CBT Intervention (PAINTrainer) Not Applicable

Detailed Description:

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 opioid taper 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 it is critical that interventions aimed at mitigating its development are implemented and evaluated in the clinical setting.

In a sample of adult men and women with chronic pain, on opioid therapy and undergoing a planned TKA, the objectives of this randomized clinical trial are to:

  1. Add a motivational interviewing component to a validated computer-assisted CBT intervention for chronic pain (PAINTrainer) to encourage opioid tapering in the 4 weeks prior to surgery.
  2. Describe the efficacy of the 4-week targeted pre-operative CBT intervention in 75 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 75 TKA patients randomized to treatment-as-usual.
  3. Describe the effects of a 4-week targeted pre-operative CBT intervention in 75 TKA patients on 48hr post-operative pain severity, and 3- and 6-month rates of CPSP in comparison to 75 TKA patients randomized to treatment-as-usual.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized clinical trial is proposed to evaluate the efficacy of the novel computer-assisted preoperative CBT/opioid sparing intervention to affect acute and chronic post-operative pain outcomes. Specifically, 150 male and female patients meeting study inclusion criteria and preparing to undergo TKA at the Penn Presbyterian Medical Center will be randomized to either receive the computer-assisted preoperative CBT intervention (n=75) or treatment-as-usual (control, n=75).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-op CBT to Reduce the Risk for Development of Chronic Post-surgical Pain in Patients Undergoing Total Knee Arthroplasty
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : October 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Computer-Assisted Preoperative CBT Intervention
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)
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.
No Intervention: Treatment-as-usual (control)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Preoperative Chronic Pain Severity [ Time Frame: baseline; prior to surgery ]
    The severity of preoperative chronic pain will be evaluated with the Brief Pain Inventory (BPI),52 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 prior to the intervention and compared to those collected just prior to surgery and at 3- and 6-month follow-up.


Secondary Outcome Measures :
  1. Preoperative Opioid Use [ Time Frame: baseline; prior to surgery ]
    Preoperative opioid use will be measured by converting to morphine equivalent daily dose (MEDD) prior to beginning the intervention, during the study visit just prior to surgery and at the 3 and 6 months follow up if the patients are still taking opioids. At each timepoint, state prescription drug monitoring program will be queried as a check on self-reported opioid use.

  2. Post-operative Opioid Use [ Time Frame: 48 hours post-operatively; 3-months; 6-months ]
    Post-operative opioid use will be measured by converting to morphine equivalent daily dose (MEDD) prior to beginning the intervention, during the study visit just prior to surgery and at the 3 and 6 months follow up if the patients are still taking opioids. At each timepoint, state prescription drug monitoring program will be queried as a check on self-reported opioid use.

  3. Pre-Op Depression [ Time Frame: baseline ]
    To measure symptoms of depression and anxiety, the PROMIS® (Patient-Reported Outcomes Measurement Information System) person-centered measures will be utilized.54 Specifically, the 8-item PROMIS depression and anxiety short forms will be compared prior to and following completion of the intervention; to evaluate the stability of CBT skills, the PROMIS will also be administered at 3 and 6 months

  4. Post-Op Depression [ Time Frame: 3-months; 6-months ]
    - To measure symptoms of depression and anxiety, the PROMIS® (Patient-Reported Outcomes Measurement Information System) person-centered measures will be utilized.54 Specifically, the 8-item PROMIS depression and anxiety short forms will be compared prior to and following completion of the intervention; to evaluate the stability of CBT skills, the PROMIS will also be administered at 3 and 6 months

  5. Pre-Op Anxiety [ Time Frame: baseline ]
    To measure symptoms of depression and anxiety, the PROMIS® (Patient-Reported Outcomes Measurement Information System) person-centered measures will be utilized.54 Specifically, the 8-item PROMIS depression and anxiety short forms will be compared prior to and following completion of the intervention; to evaluate the stability of CBT skills, the PROMIS will also be administered at 3 and 6 months

  6. Post-Op Anxiety [ Time Frame: 3-months; 6-months ]
    - To measure symptoms of depression and anxiety, the PROMIS® (Patient-Reported Outcomes Measurement Information System) person-centered measures will be utilized.54 Specifically, the 8-item PROMIS depression and anxiety short forms will be compared prior to and following completion of the intervention; to evaluate the stability of CBT skills, the PROMIS will also be administered at 3 and 6 months

  7. Pre-Op Catastrophizing [ Time Frame: baseline ]
    Pain catastrophizing will be measured by the Pain Catastrophizing Scale (PCS).53 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 prior to and following completion of the intervention and at the 3- and 6-month follow ups to assess the durability of the intervention.

  8. Post-Op Pain Severity [ Time Frame: 48 hours post-operatively ]
    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.

  9. Chronic Post-Surgical Pain [ Time Frame: 3-months; 6-months ]
    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.

  10. Post-operative chronic pain intensity [ Time Frame: 3-months; 6-months ]
    The severity of preoperative chronic pain will be evaluated with the Brief Pain Inventory (BPI),52 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 prior to the intervention and compared to those collected just prior to surgery and at 3- and 6-month follow-up.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females, age > 21 years
  2. Chronic non-malignant pain of at least 3 months duration
  3. Morphine equivalent daily dose (MEDD) > 40 milligrams for at least 3 months
  4. Able to enroll at least 4 weeks prior to planned surgery
  5. Able to speak, read and comprehend in English at the 6th grade or higher proficiency

Exclusion Criteria:

  1. Pain of malignant origin
  2. Current or past history of opioid use disorder (including those on medication-assisted therapy)
  3. Revision of TKA
  4. Comorbid CNS disease such as dementia, HIV, psychosis, poorly controlled bipolar disorder or any condition interfering with informed consent
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04814992


Contacts
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Contact: Warren G Harding 484-802-9675 warren.harding@pennmedicine.upenn.edu
Contact: Martin D Cheatle, PhD 215-746-7365 cheatle@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Warren G Harding    484-802-9675    warren.harding@pennmedicine.upenn.edu   
Contact: Martin D Cheatle, PhD    215-746-7365    cheatle@pennmedicine.upenn.edu   
Principal Investigator: Martin D Cheatle, PhD         
Principal Investigator: Peggy Compton, RN, PhD, FAAN         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Martin D Cheatle, PhD University of Pennsylvania Perelman School of Medicine
Principal Investigator: Peggy Compton, RN, PhD, FAAN University of Pennsylvania
More Information
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Additional Information:

Publications:
Beck JS. Cognitive behavior therapy: Basics and beyond (2nd ed.). (2011) New York, NY: The Guilford Press.
Cleeland CS. Measurement of pain by subjective report. In: Chapman CR, Loeser JD, editors. Issues in Pain Measurement. New York: Raven Press; pp. 391-403, 1989 Advances in Pain Research and Therapy; Vol. 12.
Sullivan MJ, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and Validation. Psychological Assessment 1995; 7(4): 524-532.
Littell RC, Milli GA, Stroup WW, Wolfinger RD. SAS System for Mixed Models, Cary, NC: SAS Institute Inc., 1996, pp. 633.
SAS Institute Inc. 2013. Base SAS® 9.4 Procedures Guide: Statistical Procedures, Second Edition. Cary, NC: SAS Institute Inc
Little RJA. Modeling the drop-out mechanism in repeated-measures studies. Journal of the American Statistical Association. 1995;90:1112-21.
Allison PD. Missing Data. Sage University Papers Series on Quantitative Applications in the Social Sciences, 2001; 07-136. Thousand Oaks, CA: Sage.

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Responsible Party: Peggy Compton, RN, PhD, Associate Professor, van Ameringen Endowed Chair, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04814992    
Other Study ID Numbers: 844378
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All records will be kept strictly confidential. No one except the researchers will know the subjects are in a research study. Data forms for the collection of health and study data will be coded with each subject's unique identification number. No data form will identify the participants by name. Hardcopies of data forms will be kept in locked files with keys held only by the study investigators. All electronic data will be stored with the password and firewall protected REDCap data collection and management system of the U Penn School of Nursing. No presentation or publication of the results of this study will refer to the individual participants or present information that would identify any participant. All persons working on the proposed work will have completed HIPAA training and the Collaborative Institutional Training Initiative (CITI) Basic Courses in the Protection of Human Research Subjects and Biomedical Focus Responsible Conduct of Research (RCR) modules.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peggy Compton, RN, PhD, University of Pennsylvania:
CPSP
Chronic Post-Surgical Pain
Cognitive Behavioral Therapy
 Total Knee Arthroplasty
Motivational Interviewing
Opioid Taper
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations