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Completed

NCT Number: NCT04814992

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

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.

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Key information

Conditions

Chronic Post-surgical Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine University City, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Computer-Assisted Preoperative CBT Intervention (PAINTrainer)

Behavioral

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.

Primary outcomes

  1. Preoperative Chronic Pain Severity

    Time frame: prior to surgery, approximately 6 weeks following baseline.

    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. Higher composite mean scores represent more pain interference (worse outcome).

Secondary outcomes

  1. Preoperative Opioid Use

    Time frame: prior to surgery, approximately 6 weeks following baseline

    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.

  2. Post-operative Opioid Use

    Time frame: 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.

  3. Pre-Op Depression

    Time frame: pre-operation, approximately 6 weeks following baseline

    To measure symptoms of depression, PROMIS® (Patient-Reported Outcomes Measurement Information System) depression person-centered scale will be utilized at baseline and pre-operation. Scores range from 8 to 40 with higher scores indicating greater severity of depression (worse outcome).

  4. Post-Op Depression

    Time frame: 6-months

    To measure symptoms of depression, the PROMIS® (Patient-Reported Outcomes Measurement Information System) depression person-centered scale will be utilized at 3- and 6-months post-operation. Scores range from 8 to 40 with higher scores indicating greater severity of depression (worse outcome).

  5. Pre-Op Anxiety

    Time frame: pre-operation, approximately 6 weeks following baseline

    To measure symptoms of anxiety, the PROMIS® (Patient-Reported Outcomes Measurement Information System) anxiety person-centered scale will be utilized at baseline and pre-operation. Scores range from 8 to 40, with higher scores indicating more severe anxiety (worse outcome).

  6. Post-Op Anxiety

    Time frame: 6-months

    To measure symptoms of anxiety, the PROMIS® (Patient-Reported Outcomes Measurement Information System) anxiety person-centered scale will be utilized at 3 and 6 months post-operation. Scores range from 8 to 40, with higher scores indicating more severe anxiety (worse outcome).

  7. Pre-Op Catastrophizing

    Time frame: pre-operation, approximately 6 weeks following baseline

    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). Scale scores range from 0 to 52; higher scores represent more pain catastrophizing (worse outcome).

  8. Post-Op Pain Severity

    Time frame: 48 hours post-operatively

    Severity of post-operative pain will be operationalized as responses on a visual analogue pain scale (VAS). 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. These will be averaged over the first 48 hours post-operatively. Higher scores represent more severe post-operative pain (worse outcome).

  9. Chronic Post-Surgical Pain

    Time frame: 6-months

    To evaluate for the presence of chronic post-surgical pain (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). This is a dichotomous measure with respondents reporting whether pain is absent (0) or present (1). A response of 1 (present) indicates that pain is present (a worse outcome).

  10. Post-operative Chronic Pain Intensity

    Time frame: 6-months

    Pain intensity is rated on a 0 (no pain) to 10 (worst pain imaginable) scale as the average pain intensity in the past 24 hours. Higher scores represent more severe pain (worse outcome).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2021
Registry last updated
Oct 17, 2024

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

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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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