In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial
Authors: Gouveia Kyle , Sprague Sheila , Gallant Jodi , Del Fabbro Gina , Leonard Jordan , Bzovsky Sofia , McKay Paula , Busse Jason W. ,   on behalf of the COPE Investigators, Bhandari Mohit , Slobogean Gerard , Thabane Lehana , McCabe Randi E. , Schemitsch Emil H. , Guyatt Gordon H. , Devereaux PJ , Gitajn I. Leah , Nowakowski Matilda , Hapidou Eleni , Chiaramonte Delia , Kehlet Henrick , Khan James , Sepehri Aresh , Fleming Natalie , Shibu Christy , Heels-Ansdell Diane , Petrisor Brad A. , Williams Dale , Ristevski Bill , Al-Asiri Jamal , Johal Herman , Denkers Matthew , Rajaratnam Kris , MacRae Sarah , Pusztai Kaitlyn , Renaud Sara , Johal Nicki , Papp Steven , Lalonde Karl-Andre , Meulenkamp Bradley , Liew Allan , Mistry Manisha , Gammon Braden , Gofton Wade , Wilkin Geoffrey , Dodd-Moher Melanie , Puskas David , Marion Travis , Lefrancois Tina , Payandeh Jubin , Cullinan Claude , Wilson Tracy , Droll Kurt , Riediger Michael , Siddiqui Rabail , Littlefield Shalyn , Chahal Simrun , Wagar Paige , Schneider Prism S. , Ogunleye Tosin , Cherppukaran Tanya , Lienhard Karin , Smith Nicholas , Anthony Sarah , Butt Krista , Selby LaShann , Kovvur Murali , Lawrence Joshua , Sampson Skyler , Turner Kristin , Jaeblon Todd , Demyanovich Haley K. , Talwar Sneh , Benzel Caroline , Chockbengboun Theresa , Mullin Devin , Appleton Paul J. , Wixted John J. , Rodriguez Edward K. , McTague Michael F. , Wagner Katiri , Brackpool Kristina , Hegermiller Kate , Nguyen Nhi , Natoli Roman M. , Fentz Courteney , Diaz Maricela , Niceley Jill , Garrett Tammy , Jeray Kyle J. , Schaller Thomas M. , Sridhar Michael S. , Adams John D. , Gurich Richard W. , Tanner Stephanie L. , Adams Kyle , Donohue Michelle , Bray Emily , Brignull Calleigh , Sprouse Harper , Tieszer Christina , Stone Trevor , Viskontas Darius , Zomar Mauri 
Published: January 2024

Abstract
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