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Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial.

ABSTRACT: Objective 1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design A pilot randomized controlled trial (RCT) with two parallel groups. Setting A supraregional level 1 trauma center. Methods Fifty-six adult patients were randomized. Participants received the intervention or an educational pamphlet. Several parameters were evaluated to determine the feasibility of the research methods. The potential efficacy of iPACT-E-Trauma was evaluated with measures of pain intensity and pain interference with activities. Results More than 80% of eligible patients agreed to participate, and an attrition rate of ?18% was found. Less than 40% of screened patients were eligible, and obtaining baseline data took 48?hours postadmission on average. Mean scores of mild pain intensity and pain interference with daily activities (<4/10) on average were obtained in both groups at three and six months postinjury. Between 20% and 30% of participants reported moderate to high mean scores (?4/10) on these outcomes at the two follow-up time measures. The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury. Low mean scores of pain catastrophizing (Pain Catastrophizing Scale score?

SUBMITTER: Berube M

PROVIDER: S-EPMC6784743 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial.

Bérubé M M Gélinas C C Feeley N N Martorella G G Côté J J Laflamme G Y GY Rouleau D M DM Choinière M M

Pain medicine (Malden, Mass.) 20191001 10

Objective 1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design A pilot randomized controlled trial (RCT) with two parallel groups. Setting A supraregional level 1 trauma center. Methods Fifty-six adult patients were randomized. Participants received the interventio ...[more]

PMID: 30840085

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Project description:BACKGROUND:A transition from acute to chronic pain frequently occurs after major lower extremity trauma. While the risk factors for developing chronic pain in this population have been extensively studied, research findings on interventions aiming to prevent chronic pain in the trauma context are scarce. Therefore, we developed 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). OBJECTIVE:This study aimed to assess the feasibility and acceptability of iPACT-E-Trauma. METHODS:Using a descriptive design, the intervention was initiated at a supra-regional level-1 trauma center. Twenty-eight patients ≥18 years old with major lower extremity trauma, presenting with moderate to high pain intensity 24 hours post-injury were recruited. Feasibility assessment was two-fold: 1) whether the intervention components could be provided as planned to ≥80% of participants and 2) whether ≥80% of participants could complete the intervention. The rates for both these variables were calculated. The E-Health Acceptability Questionnaire and the Treatment Acceptability and Preference Questionnaire were used to assess acceptability. Mean scores were computed to determine the intervention's acceptability. RESULTS:More than 80% of participants received the session components relevant to their condition. However, the Web pages for session 2, on the analgesics prescribed, were accessed by 71% of participants. Most sessions were delivered according to the established timeline for ≥80% of participants. Session 3 and in-person coaching meetings had to be provider earlier for ≥35% of participants. Session duration was 30 minutes or less on average, as initially planned. More than 80% of participants attended sessions and <20% did not apply self-management behaviors relevant to their condition, with the exception of deep breathing relaxation exercises which was not applied by 40% of them. Web and in-person sessions were assessed as very acceptable (mean scores ≥3 on a 0 to 4 descriptive scale) across nearly all acceptability attributes. CONCLUSIONS:Findings showed that the iPACT-E-Trauma intervention is feasible and was perceived as highly acceptable by participants. Further tailoring iPACT-E-Trauma to patient needs, providing more training time for relaxation techniques, and modifying the Web platform to improve its convenience could enhance the feasibility and acceptability of the intervention. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6ynibjPHa).

Project description:BackgroundAcute 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).ObjectiveThis 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.MethodsA 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.ResultsFifty-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.ConclusionsChronic 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 registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6rR8G2vMs).

Project description:Traumatic heterotopic ossification (tHO) commonly develops in wounded service members who sustain high-energy and blast-related traumatic amputations. Currently, no safe and effective preventive measures have been identified for this patient population. Bone morphogenetic protein (BMP) signaling blockade has previously been shown to reduce ectopic bone formation in genetic models of HO. In this study, we demonstrate the efficacy of small-molecule inhibition with LDN193189 (ALK2/ALK3 inhibition), LDN212854 (ALK2-biased inhibition), and BMP ligand trap ALK3-Fc at inhibiting early and late osteogenic differentiation of tissue-resident mesenchymal progenitor cells (MPCs) harvested from mice subjected to burn/tenotomy, a well-characterized trauma-induced model of HO. Using an established rat tHO model of blast-related extremity trauma and methicillin-resistant Staphylococcus aureus infection, a significant decrease in ectopic bone volume was observed by micro-computed tomography imaging following treatment with LDN193189, LDN212854, and ALK3-Fc. The efficacy of LDN193189 and LDN212854 in this model was associated with weight loss (17%-19%) within the first two postoperative weeks, and in the case of LDN193189, delayed wound healing and metastatic infection was observed, while ALK3-Fc was well tolerated. At day 14 following injury, RNA-Seq and quantitative reverse transcriptase-polymerase chain reaction analysis revealed that ALK3-Fc enhanced the expression of skeletal muscle structural genes and myogenic transcriptional factors while inhibiting the expression of inflammatory genes. Tissue-resident MPCs harvested from rats treated with ALK3-Fc exhibited reduced osteogenic differentiation, proliferation, and self-renewal capacity and diminished expression of genes associated with endochondral ossification and SMAD-dependent signaling pathways. Together, these results confirm the contribution of BMP signaling in osteogenic differentiation and ectopic bone formation and that a selective ligand-trap approach such as ALK3-Fc may be an effective and tolerable prophylactic strategy for tHO.

Dataset Information

Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial.

Publications

Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial.

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