A Hybrid Web-Based and In-Person Self-Management Intervention to Prevent Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): Protocol for a Pilot Single-Blind Randomized Controlled Trial
Open accessAbstract
BACKGROUND: Acute pain frequently transitions to chronic pain after major lower extremity trauma (ET). Several modifiable psychological risk and protective factors have been found to contribute to, or prevent, chronic pain development. Some empirical evidence has shown that interventions, including cognitive and behavioral strategies that promote pain self-management, could prevent chronic pain. However, the efficacy of such interventions has never been demonstrated in ET patients. We have designed a self-management intervention to prevent acute to chronic pain transition after major lower extremity trauma (iPACT-E-Trauma). OBJECTIVE: This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and research methods of the intervention, as well as the potential effects of iPACT-E-Trauma, on pain intensity and pain interference with daily activities. METHODS: A 2-arm single-blind pilot RCT will be conducted. Participants will receive the iPACT-E-Trauma intervention (experimental group) or an educational pamphlet (control group) combined with usual care. Data will be collected at baseline, during iPACT-E-Trauma delivery, as well as at 3 and 6 months post-injury. Primary outcomes are pain intensity and pain interference with daily living activities at 6 months post-injury. Secondary outcomes are pain self-efficacy, pain acceptance, pain catastrophizing, pain-related fear, anxiety and depression symptoms, health care service utilization, and return to work. RESULTS: Fifty-three patients were recruited at the time of manuscript preparation. Comprehensive data analyses will be initiated in July 2017. Study results are expected to be available in 2018. CONCLUSIONS: Chronic pain is an important problem after major lower ET. However, no preventive intervention has yet been successfully proven in these patients. This study will focus on developing a feasible intervention to prevent acute to chronic pain transition in the context of ET. Findings will allow for the refinement of iPACT-E-Trauma and methodological parameters in prevision of a full-scale multi-site RCT. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6rR8G2vMs).
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The development of hybrid interventions has been on the rise, and these interventions have been successfully used to deliver behavioral symptom management strategies.
“While the development of hybrid interventions has been on the rise, and these interventions have been successfully used to deliver behavioral symptom management strategies [87, 88]”
From Improving symptom management for survivors of young adult cancer: rationale and study protocol for a pilot randomized controlled trial (2024) · cites this paper as [88]
The Methods > Intervention section describes a hybrid web-based and in-person intervention and reports positive results for cognitive-behavioral interventions delivered online, including those combined with live clinician interactions. But this paper is a trial protocol, not evidence that its own intervention has succeeded, and the copy does not establish that development of hybrid interventions specifically has been on the rise. The Introduction discusses growing interest in preventive self-management interventions more generally. (LLM, conf=0.85)
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References 88 · Cited by 10
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- [30]Flor H Turk DC Chronic pain integrated biobehavioral perspective 2011 Seattle, WA IASP Press
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- Authors
- Bérubé, M., Gélinas, C., Martorella, G., Côté, J., Feeley, N., Laflamme, G.-Y., Rouleau, D., & Choinière, M.
- Affiliations
- Jewish General Hospital (CA)
- Florida State University (US)
- Centre Hospitalier de l’Université de Montréal (CA)
- Hôpital du Sacré-Cœur de Montréal (CA)
- ORCID
- Venue
- JMIR Research Protocols
- Publisher
- JMIR Publications Inc.
- Published
- 2017-06-26
- Volume
- 6
- Issue
- 6
- Pages
- e125
- ISSN
- 1929-0748 (ISSN-L)
- PMC
- PMC5504342
- OpenAlex
- W2680133100
- Cited by
- 10
- References
- 88
- Citations by year
- 2024: 2 · 2020: 1 · 2019: 3 · 2018: 4
- FWCI
- 1.53
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR Research Protocols (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Réseau québécois de recherche sur la douleur
- Canadian Institutes of Health Research (140934_1)
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pediatric Pain Management Techniques
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
- Keywords
- chronic pain prevention, acute to chronic pain transition, pain self-management, pain self-efficacy, pain acceptance, pain catastrophizing, fear of pain, pain intensity, pain interference with daily activities, return to work, health care utilization, anxiety and depression
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