Chronic Post-Surgical Pain
Conditions
Keywords
CPSP, Chronic Post-Surgical Pain, Cognitive Behavioral Therapy, Total Knee Arthroplasty, Motivational Interviewing, Opioid Taper
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 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.
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.
Interventions
BEHAVIORALComputer-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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized clinical trial is proposed to evaluate the efficacy of the novel computer-assisted preoperative CBT with integrating motivational interviewing intervention to affect acute and chronic post-operative pain outcomes. Specifically, 90 adult patients over the age of 21 meeting study inclusion criteria and preparing to undergo TKA at the Department of Orthopedic Surgery at Penn Presbyterian Medical Center, Penn Medicine University City, Penn Medicine Radnor, and Pennsylvania Hospital will be randomized to either receive the computer-assisted preoperative CBT intervention (n=45) or treatment-as-usual (control, n=45).
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Chronic Pain Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Opioid Use | 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. |
| Pre-Op Depression | 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). |
| Post-Op Depression | 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). |
| Pre-Op Anxiety | 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). |
| Preoperative Opioid Use | 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. |
| Pre-Op Catastrophizing | 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). |
| Post-Op Pain Severity | 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). |
| Chronic Post-Surgical Pain | 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). |
| Post-operative Chronic Pain Intensity | 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). |
| Post-Op Anxiety | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Computer-Assisted Preoperative CBT Intervention | Treatment-as-usual (Control) | Total |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 7.69 | 57 years STANDARD_DEVIATION 8.33 | 56 years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 20 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Opioid morphine equivalents/day | 15.8 Opioid morphine equivalents/day STANDARD_DEVIATION 36.36 | 11.4 Opioid morphine equivalents/day STANDARD_DEVIATION 24.98 | 13.6 Opioid morphine equivalents/day STANDARD_DEVIATION 30.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Preoperative Chronic Pain Severity | 4.6 units on a scale | Standard Deviation 2.13 |
| Treatment-as-usual (Control) | Preoperative Chronic Pain Severity | 4.4 units on a scale | Standard Deviation 2.31 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Chronic Post-Surgical Pain | 6 Participants |
| Treatment-as-usual (Control) | Chronic Post-Surgical Pain | 4 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Post-Op Anxiety | 9.1 score on a scale | Standard Deviation 3.66 |
| Treatment-as-usual (Control) | Post-Op Anxiety | 10.8 score on a scale | Standard Deviation 7.12 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Post-Op Depression | 8.5 score on a scale | Standard Deviation 1.02 |
| Treatment-as-usual (Control) | Post-Op Depression | 10.6 score on a scale | Standard Deviation 4.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Post-operative Chronic Pain Intensity | 3.1 units on a scale | Standard Deviation 1.9 |
| Treatment-as-usual (Control) | Post-operative Chronic Pain Intensity | 3.7 units on a scale | Standard Deviation 2.59 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Post-operative Opioid Use | 11.4 mg | Standard Deviation 31.58 |
| Treatment-as-usual (Control) | Post-operative Opioid Use | 12.0 mg | Standard Deviation 29.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Post-Op Pain Severity | 4.6 units on a scale | Standard Deviation 2.18 |
| Treatment-as-usual (Control) | Post-Op Pain Severity | 4.8 units on a scale | Standard Deviation 1.98 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Pre-Op Anxiety | 13.0 score on a scale | Standard Deviation 6.78 |
| Treatment-as-usual (Control) | Pre-Op Anxiety | 12.4 score on a scale | Standard Deviation 5.27 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Pre-Op Catastrophizing | 10.8 score on a scale | Standard Deviation 7.9 |
| Treatment-as-usual (Control) | Pre-Op Catastrophizing | 12.2 score on a scale | Standard Deviation 11.17 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Pre-Op Depression | 10.6 score on a scale | Standard Deviation 3.69 |
| Treatment-as-usual (Control) | Pre-Op Depression | 11.2 score on a scale | Standard Deviation 4.69 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Preoperative Opioid Use | 15.8 mg | Standard Deviation 36.36 |
| Treatment-as-usual (Control) | Preoperative Opioid Use | 11.4 mg | Standard Deviation 24.98 |