In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial
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-avoida...
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-023-01430-y |
| _version_ | 1797363691489853440 |
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| author | Kyle Gouveia Sheila Sprague Jodi Gallant Gina Del Fabbro Jordan Leonard Sofia Bzovsky Paula McKay Jason W. Busse on behalf of the COPE Investigators |
| author_facet | Kyle Gouveia Sheila Sprague Jodi Gallant Gina Del Fabbro Jordan Leonard Sofia Bzovsky Paula McKay Jason W. Busse on behalf of the COPE Investigators |
| author_sort | Kyle Gouveia |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-03-08T16:23:40Z |
| format | Article |
| id | doaj.art-bf704683ceee406981ad49bae6636bd1 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-03-08T16:23:40Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-bf704683ceee406981ad49bae6636bd12024-01-07T12:11:42ZengBMCPilot and Feasibility Studies2055-57842024-01-011011710.1186/s40814-023-01430-yIn-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trialKyle Gouveia0Sheila Sprague1Jodi Gallant2Gina Del Fabbro3Jordan Leonard4Sofia Bzovsky5Paula McKay6Jason W. Busse7on behalf of the COPE InvestigatorsDivision of Orthopaedic Surgery, Department of Surgery, McMaster UniversityDivision of Orthopaedic Surgery, Department of Surgery, McMaster UniversityDivision of Orthopaedic Surgery, Department of Surgery, McMaster UniversityDivision of Orthopaedic Surgery, Department of Surgery, McMaster UniversityDivision of Orthopaedic Surgery, Department of Surgery, McMaster UniversityDivision of Orthopaedic Surgery, Department of Surgery, McMaster UniversityDivision of Orthopaedic Surgery, Department of Surgery, McMaster UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityAbstract 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/NCT03196258https://doi.org/10.1186/s40814-023-01430-yExtremity fracturesPersistent post-surgical painCognitive behavioral therapy |
| spellingShingle | Kyle Gouveia Sheila Sprague Jodi Gallant Gina Del Fabbro Jordan Leonard Sofia Bzovsky Paula McKay Jason W. Busse on behalf of the COPE Investigators In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial Pilot and Feasibility Studies Extremity fractures Persistent post-surgical pain Cognitive behavioral therapy |
| title | In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial |
| title_full | In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial |
| title_fullStr | In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial |
| title_full_unstemmed | In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial |
| title_short | In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial |
| title_sort | in person cognitive behavioural therapy vs usual care after surgical management of extremity fractures an unsuccessful feasibility trial |
| topic | Extremity fractures Persistent post-surgical pain Cognitive behavioral therapy |
| url | https://doi.org/10.1186/s40814-023-01430-y |
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