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

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    90
  • sponsor
    University of Pennsylvania
Updated on 7 October 2022
Accepts healthy volunteers

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 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.

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.

Details
Condition Chronic Post-Surgical Pain
Treatment Computer-Assisted Preoperative CBT Intervention (PAINTrainer)
Clinical Study IdentifierNCT04814992
SponsorUniversity of Pennsylvania
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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