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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04814992
Other study ID # 844378
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Penn Medicine University City Philadelphia Pennsylvania
United States Penn Presbyterian Medical Center Philadelphia Pennsylvania
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States Penn Medicine Radnor Radnor Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (55)

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* Note: There are 55 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
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. baseline; prior to surgery; 3-months; 6-months
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. baseline; prior to surgery
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. 48 hours post-operatively; 3-months; 6-months
Secondary Pre-Op Depression 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
Secondary Post-Op Depression 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
Secondary Pre-Op Anxiety 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
Secondary Post-Op Anxiety 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
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). 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
Secondary Post-Op Pain Severity 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
Secondary Chronic Post-Surgical Pain 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
Secondary Post-operative chronic pain intensity 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
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