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In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2024年1月6日

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  • Kyle Gouveia,
  • Sheila Sprague,
  • Jodi Gallant,
  • Gina Del Fabbro,
  • Jordan Leonard,
  • Sofia Bzovsky,
  • Paula McKay,
  • Jason W. Busse,
  • Mohit Bhandari,
  • Gerard Slobogean,
  • Lehana Thabane,
  • Randi E. McCabe,
  • Emil H. Schemitsch,
  • Gordon H. Guyatt,
  • PJ Devereaux,
  • I. Leah Gitajn,
  • Matilda Nowakowski,
  • Eleni Hapidou,
  • Delia Chiaramonte,
  • Henrick Kehlet,
  • James Khan,
  • Aresh Sepehri,
  • Natalie Fleming,
  • Christy Shibu,
  • Diane Heels-Ansdell,
  • Brad A. Petrisor,
  • Dale Williams,
  • Bill Ristevski,
  • Jamal Al-Asiri,
  • Herman Johal,
  • Matthew Denkers,
  • Kris Rajaratnam,
  • Sarah MacRae,
  • Kaitlyn Pusztai,
  • Sara Renaud,
  • Nicki Johal,
  • Steven Papp,
  • Karl-Andre Lalonde,
  • Bradley Meulenkamp,
  • Allan Liew,
  • Manisha Mistry,
  • Braden Gammon,
  • Wade Gofton,
  • Geoffrey Wilkin,
  • Melanie Dodd-Moher,
  • David Puskas,
  • Travis Marion,
  • Tina Lefrancois,
  • Jubin Payandeh,
  • Claude Cullinan,
  • Tracy Wilson,
  • Kurt Droll,
  • Michael Riediger,
  • Rabail Siddiqui,
  • Shalyn Littlefield,
  • Simrun Chahal,
  • Paige Wagar,
  • Prism S. Schneider,
  • Tosin Ogunleye,
  • Tanya Cherppukaran,
  • Karin Lienhard,
  • Nicholas Smith,
  • Sarah Anthony,
  • Krista Butt,
  • LaShann Selby,
  • Murali Kovvur,
  • Joshua Lawrence,
  • Skyler Sampson,
  • Kristin Turner,
  • Todd Jaeblon,
  • Haley K. Demyanovich,
  • Sneh Talwar,
  • Caroline Benzel,
  • Theresa Chockbengboun,
  • Devin Mullin,
  • Paul J. Appleton,
  • John J. Wixted,
  • Edward K. Rodriguez,
  • Michael F. McTague,
  • Katiri Wagner,
  • Kristina Brackpool,
  • Kate Hegermiller,
  • Nhi Nguyen,
  • Roman M. Natoli,
  • Courteney Fentz,
  • Maricela Diaz,
  • Jill Niceley,
  • Tammy Garrett,
  • Kyle J. Jeray,
  • Thomas M. Schaller,
  • Michael S. Sridhar,
  • John D. Adams,
  • Richard W. Gurich Jr.,
  • Stephanie L. Tanner,
  • Kyle Adams,
  • Michelle Donohue,
  • Emily Bray,
  • Calleigh Brignull,
  • Harper Sprouse,
  • Christina Tieszer,
  • Trevor Stone,
  • Darius Viskontas,
  • Mauri Zomar

摘要

Background

Extremity fractures are common, and most are managed operatively; however, despite successful reduction, up to half of patients report persistent post-surgical pain. Furthermore, psychological factors such as stress, distress, anxiety, depression, catastrophizing, and fear-avoidance behaviors have been associated with the development of chronic pain. The purpose of this pilot study was to examine the feasibility of a randomized controlled trial to determine the effect of in-person cognitive behavioral therapy (CBT) vs. usual care on persistent post-surgical pain among patients with a surgically managed extremity fracture.

Methods

Eligible patients were randomized to either in-person CBT or usual care. We used four criteria to judge the composite measure of feasibility: 1) successful implementation of CBT at each clinical site, 2) 40 patients recruited within 6 months, 3) treatment compliance in a minimum 36 of 40 participants (90%), and 4) 32 of 40 participants (80%) achieving follow-up at one year. The primary clinical outcome was persistent post-surgical pain at one year after surgery.

Results

Only two of the four participating sites were able to implement the CBT regimen due to difficulties with identifying certified therapists who had the capacity to accommodate additional patients into their schedule within the required timeframe (i.e., 8 weeks of their fracture). Given the challenges associated with CBT implementation, only one site was able to actively recruit patients. This site screened 86 patients and enrolled 3 patients (3.5%) over a period of three months. Participants were unable to comply with the in-person CBT, with no participants attending an in-person CBT session. Follow-up at one year could not be assessed as the pilot study was stopped early, three months into the study, due to failure to achieve the other three feasibility criteria.

Conclusion

Our pilot trial failed to demonstrate the feasibility of a trial of in-person CBT versus usual care to prevent persistent pain after surgical repair of traumatic long-bone fractures and re-enforces the importance of establishing feasibility before embarking on definitive trials. Protocol modifications to address the identified barriers include the delivery of our intervention as a therapist-guided, remote CBT program.

Trial registration

ClinicalTrials.gov (Identifier NCT03196258); Registered June 22, 2017, https://clinicaltrials.gov/ct2/show/NCT03196258