An interventional study of Computer-Assisted Preoperative CBT Intervention (PAINTrainer) in Chronic Post-Surgical Pain, sponsored by University of Pennsylvania. Completed at 4 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
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:
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Exclusion Criteria:
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)
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.
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.
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. Higher composite mean scores represent more pain interference (worse outcome).
Time frame: prior to surgery, approximately 6 weeks following baseline.
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.
Time frame: prior to surgery, approximately 6 weeks following baseline
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.
Time frame: 6-months
Pre-Op Depression
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).
Time frame: pre-operation, approximately 6 weeks following baseline
Post-Op Depression
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).
Time frame: 6-months
Pre-Op Anxiety
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).
Time frame: pre-operation, approximately 6 weeks following baseline
Post-Op Anxiety
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).
Time frame: 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). Scale scores range from 0 to 52; higher scores represent more pain catastrophizing (worse outcome).
Time frame: pre-operation, approximately 6 weeks following baseline
Post-Op Pain Severity
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).
Time frame: 48 hours post-operatively
Chronic Post-Surgical Pain
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).
Time frame: 6-months
Post-operative Chronic Pain Intensity
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).
Time frame: 6-months
| Milestone | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Started | 27 | 27 |
| Completed | 20 | 20 |
| Not completed | 7 | 7 |
| Withdrew: Withdrawal by subject | 6 | 3 |
| Withdrew: Lost to follow-up | 1 | 4 |
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).
| units on a scale | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Preoperative Chronic Pain Severity | 4.6 ± 2.13 | 4.4 ± 2.31 |
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.
| mg | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Preoperative Opioid Use | 15.8 ± 36.36 | 11.4 ± 24.98 |
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.
| mg | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Post-operative Opioid Use | 11.4 ± 31.58 | 12.0 ± 29.60 |
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).
| score on a scale | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Pre-Op Depression | 10.6 ± 3.69 | 11.2 ± 4.69 |
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).
| score on a scale | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Post-Op Depression | 8.5 ± 1.02 | 10.6 ± 4.60 |
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).
| score on a scale | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Pre-Op Anxiety | 13.0 ± 6.78 | 12.4 ± 5.27 |
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).
| score on a scale | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Post-Op Anxiety | 9.1 ± 3.66 | 10.8 ± 7.12 |
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).
| score on a scale | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Pre-Op Catastrophizing | 10.8 ± 7.90 | 12.2 ± 11.17 |
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).
| units on a scale | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Post-Op Pain Severity | 4.6 ± 2.18 | 4.8 ± 1.98 |
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).
| Participants | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Chronic Post-Surgical Pain | 6 | 4 |
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).
| units on a scale | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) |
|---|---|---|
| Post-operative Chronic Pain Intensity | 3.1 ± 1.90 | 3.7 ± 2.59 |
Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Treatment-as-usual (Control) | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) | Total |
|---|---|---|---|
| Mean | 54 ± 7.69 | 57 ± 8.33 | 56 ± 8.10 |
| Sex: Female, Male(Participants) | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) | Total |
|---|---|---|---|
| Female | 13 | 9 | 22 |
| Male | 7 | 11 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 18 | 20 | 38 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 15 | 15 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Opioid morphine equivalents/day(Opioid morphine equivalents/day) | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) | Total |
|---|---|---|---|
| Mean | 15.8 ± 36.36 | 11.4 ± 24.98 | 13.6 ± 30.87 |
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Plan to share: No — 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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