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 < 30) and anxiety and depression (Hospital Anxiety and Depression Scale scores ≤ 10) were obtained through the end of the study. Conclusions Some challenges that need to be addressed in a future RCT include the small proportion of screened patients who were eligible and the selection of appropriate tools to measure the development of chronic pain. Studies will need to be conducted with patients presenting more serious injuries and psychological vulnerability or using a stepped screening approach.

The Effect of Psychological Interventions on the Prevention of Chronic Pain in Adults

“…We included 18 trials in the qualitative synthesis. 27,28,44,[63][64][65][66][67][68][69][70][71][72][73][74][75][76][77][78] However, only 11 trials, were included in the meta-analysis based on the possibility of using data as analyzed and the unavailability of required data from some trials' authors. 27,67,68,[74][75][76][77] These trials were published 8 to 33 years before the conduction of the meta-analyses and authors no longer had access to their database, did not answer us when we contacted them, or could not be reached.…”

“…and a research assistant) using a "risk of bias table" in DistillerSR developed according to the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. 41,43 One of the selected trials was performed by the first author 44 and she was therefore not involved in the assessment of risk of bias for this trial. Judgment of high, low, or unclear bias was made.…”

“…Of the trials entered in the meta-analyses, 5 were performed with back pain participants, 63,65,66,69-71 4 with participants with multiple pain sites (eg, neck, shoulders, back, hip, knee), 28,64,72,73 and 2 with participants with limb pain secondary to traumatic injuries. 44,78 The time elapsed since pain onset was between 6 weeks and 3 months in 6 trials 65,[69][70][71][72]78 and <15 days in 2 trials. 44,63 Three trials 28,64,69 did not provide details on the number of weeks or months elapsed since pain onset.…”

Developing mHealth to the Context and Valuation of Injured Patients and Professionals in Hospital Trauma Care: Qualitative and Quantitative Formative Evaluations

“…This model also appeared to be useful when the COVID-19 pandemic forced (orthopedic) outpatient clinics to limit face-to-face consultations [ 11 ]. Another concept aimed to prevent persistent pain symptoms after lower extremity injuries with web-based cognitive behavioral interventions supported by a nurse [ 12 , 13 ]. A preliminary randomized feasibility trial showed less pain intensity in comparison with the provision of an educational pamphlet.…”

Stratégies pour éviter l’utilisation à long terme des opioïdes après un traumatisme : enquête sur les pratiques canadiennes

“…Traumatic injuries and their surgical management often result in high-intensity pain, 1 – 12 usually requiring opioids for pain relief. 13 , 14 Nevertheless, up to 20% of patients with traumatic injuries become long-term opioid users (≥ three months) 15 – 19 and this percentage may climb to 60% in those with risk factors such as mental health problems, a history of substance use problems, or living with chronic pain.…”