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Chronic Post-Surgical PainNCT04814992

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

A study testing Computer-Assisted Preoperative CBT Intervention (PAINTrainer) in people with Chronic Post-Surgical Pain, run by University of Pennsylvania at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Post-Surgical Pain
What is being tested?
Computer-Assisted Preoperative CBT Intervention (PAINTrainer)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
4 sitesUnited States
Study dates
1 Oct 2020to 31 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Penn Medicine University City

    Philadelphia, Pennsylvania, 19104

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19129

  • Penn Medicine Radnor

    Radnor, Pennsylvania, 19087

Other trials in United States

About this study

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

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.

Read the 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.
Being tested
Computer-Assisted Preoperative CBT Intervention (PAINTrainer)
Keywords
CPSP, Chronic Post-Surgical Pain, Cognitive Behavioral Therapy, Total Knee Arthroplasty, Motivational Interviewing, Opioid Taper
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer-Assisted Preoperative CBT Intervention (PAINTrainer)Behavioural

    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.

Study groups in NCT04814992
Study groupRoleWhat they receive
Computer-Assisted Preoperative CBT InterventionActive comparatorPatients 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.
Receives: Behavioral: Computer-Assisted Preoperative CBT Intervention (PAINTrainer)
Treatment-as-usual (control)No interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: prior to surgery, approximately 6 weeks following baseline.

Secondary outcomes (10)

  1. 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.

    Measured: prior to surgery, approximately 6 weeks following baseline

  2. 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.

    Measured: 6-months

  3. 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).

    Measured: pre-operation, approximately 6 weeks following baseline

  4. 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).

    Measured: 6-months

  5. 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).

    Measured: pre-operation, approximately 6 weeks following baseline

  6. 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).

    Measured: 6-months

  7. 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).

    Measured: pre-operation, approximately 6 weeks following baseline

  8. 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).

    Measured: 48 hours post-operatively

  9. 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).

    Measured: 6-months

  10. 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).

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start1 Oct 2020
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04814992
Sponsor's protocol ID
844378
Status last verified
Jul 2024
First submitted
17 Mar 2021
Last updated
17 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.

    PubMed 28801208

  • Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.

    PubMed 30180053

  • Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.

    PubMed 25542191

  • Petersen KK, Simonsen O, Laursen MB, Nielsen TA, Rasmussen S, Arendt-Nielsen L. Chronic postoperative pain after primary and revision total knee arthroplasty. Clin J Pain. 2015 Jan;31(1):1-6. doi: 10.1097/AJP.0000000000000146.

    PubMed 25485953

  • Petersen KK, Graven-Nielsen T, Simonsen O, Laursen MB, Arendt-Nielsen L. Preoperative pain mechanisms assessed by cuff algometry are associated with chronic postoperative pain relief after total knee replacement. Pain. 2016 Jul;157(7):1400-1406. doi: 10.1097/j.pain.0000000000000531.

    PubMed 27331347

  • Schug SA, Bruce J. Risk stratification for the development of chronic postsurgical pain. Pain Rep. 2017 Oct 31;2(6):e627. doi: 10.1097/PR9.0000000000000627. eCollection 2017 Nov.

    PubMed 29392241

  • Lavand'homme P. Transition from acute to chronic pain after surgery. Pain. 2017 Apr;158 Suppl 1:S50-S54. doi: 10.1097/j.pain.0000000000000809. No abstract available.

    PubMed 28134653

  • Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238.

    PubMed 29738328

  • Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.

    PubMed 26871536

  • Westermann RW, Anthony CA, Bedard N, Glass N, Bollier M, Hettrich CM, Wolf BR. Opioid Consumption After Rotator Cuff Repair. Arthroscopy. 2017 Aug;33(8):1467-1472. doi: 10.1016/j.arthro.2017.03.016. Epub 2017 May 29.

    PubMed 28571723

  • Parsons B, Schaefer C, Mann R, Sadosky A, Daniel S, Nalamachu S, Stacey BR, Nieshoff EC, Tuchman M, Anschel A. Economic and humanistic burden of post-trauma and post-surgical neuropathic pain among adults in the United States. J Pain Res. 2013 Jun 17;6:459-69. doi: 10.2147/JPR.S44939. Print 2013.

    PubMed 23825931

  • Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.

    PubMed 19402781

  • Borsook D, Youssef AM, Simons L, Elman I, Eccleston C. When pain gets stuck: the evolution of pain chronification and treatment resistance. Pain. 2018 Dec;159(12):2421-2436. doi: 10.1097/j.pain.0000000000001401.

    PubMed 30234696

  • Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.

    PubMed 22337572

  • Buvanendran A, Della Valle CJ, Kroin JS, Shah M, Moric M, Tuman KJ, McCarthy RJ. Acute postoperative pain is an independent predictor of chronic postsurgical pain following total knee arthroplasty at 6 months: a prospective cohort study. Reg Anesth Pain Med. 2019 Mar;44(3):e100036. doi: 10.1136/rapm-2018-100036. Epub 2019 Feb 15.

    PubMed 30770420

Questions about this trial

What is this clinical trial studying?

A study testing Computer-Assisted Preoperative CBT Intervention (PAINTrainer) in people with Chronic Post-Surgical Pain, run by University of Pennsylvania at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative Chronic Pain Severity (time frame: prior to surgery, approximately 6 weeks following baseline.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04814992, which also lists 55 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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