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

January 2, 2024 updated by: Peggy Compton, RN, PhD, University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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:

  1. 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.
  2. 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.
  3. 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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Medicine University City
      • Philadelphia, Pennsylvania, United States, 19129
        • Pennsylvania Hospital
      • Radnor, Pennsylvania, United States, 19087
        • Penn Medicine Radnor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Chronic Pain Severity
Time Frame: baseline; prior to surgery; 3-months; 6-months
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
Time Frame: baseline; prior to surgery
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
Time Frame: 48 hours post-operatively; 3-months; 6-months
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
Time Frame: baseline; pre-operation
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
Time Frame: 3-months; 6-months
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
Time Frame: baseline; pre-operation
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
Time Frame: 3-months; 6-months
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
Time Frame: baseline; pre-operation
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
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.
48 hours post-operatively
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.
3-months; 6-months
Post-operative chronic pain intensity
Time Frame: 3-months; 6-months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Martin D Cheatle, PhD, University of Pennsylvania
  • Principal Investigator: Peggy Compton, RN, PhD, FAAN, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 844378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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