StressModex for Post-Traumatic Neck Pain

Overview

Post-traumatic neck pain is a common consequence of traffic-related and other accidental injuries. While many individuals recover, a subgroup develops persistent pain, disability, and psychological distress. Building on previous adaptation and feasibility work, this randomised pilot trial will assess the feasibility of conducting a future definitive randomised controlled trial comparing StressModex plus treatment as usual (TAU) with TAU alone in individuals at risk of persistent post-traumatic neck pain. The primary feasibility objectives are to assess recruitment using a revised multi-source recruitment strategy and participant retention and remote outcome data collection. Secondary feasibility objectives are to assess the feasibility and acceptability of randomisation, characterise TAU and concurrent healthcare use, and estimate parameters relevant to the sample size calculation for a future definitive RCT. Intervention fidelity, adherence, acceptability, safety, and practical aspects of intervention delivery will additionally be monitored. The pilot trial is not designed or powered to evaluate the effectiveness of StressModex.

Persistent post-traumatic neck pain is associated with substantial disability, reduced quality of life, psychological distress, and societal costs. Previous research has identified psychological stress responses and hyperarousal symptoms following trauma as important predictors of poor recovery. Interventions combining physical rehabilitation with psychological approaches may therefore be relevant for individuals at increased risk of persistent post-traumatic neck pain. StressModex integrates guideline-based physiotherapy with Stress Inoculation Training (SIT) and has previously been adapted to a Danish healthcare context. A preceding feasibility study evaluated the acceptability and feasibility of the adapted intervention and study procedures. While the intervention was found to be acceptable and deliverable, recruitment and retention were identified as important remaining uncertainties. Based on these findings, the recruitment strategy and trial procedures have subsequently been revised. Building on this previous adaptation and feasibility work, the present study is designed as a two-arm randomised pilot trial. The aim is to assess the feasibility of conducting a future definitive RCT evaluating StressModex plus treatment as usual (TAU) compared with TAU alone and to generate information required to refine the design of the definitive trial. Adults with post-traumatic neck pain of less than six months' duration who demonstrate both moderate neck-related disability and hyperarousal symptoms will be recruited through a revised multi-source recruitment strategy, including emergency departments, hospital records, healthcare providers and settings, health insurance providers, and public advertisements including social media. Following informed consent and completion of baseline questionnaires, participants will be randomised in a 1:1 ratio to either StressModex plus TAU or TAU alone. StressModex consists of 10 physiotherapy sessions delivered over six weeks and combines individually tailored, guideline-based physiotherapy with SIT. SIT is integrated into six sessions and focuses on understanding and managing stress responses, developing coping and stress-management skills, and applying these skills in relevant situations. Participants in both trial arms remain free to seek healthcare according to usual Danish practice. The primary objectives are to assess whether the revised multi-source recruitment strategy can identify and include eligible participants at a rate sufficient to support a future definitive RCT and to assess participant retention and the feasibility and completeness of remote outcome data collection through 6 months. Secondary objectives are to assess the feasibility and acceptability of randomisation, characterise TAU, and concurrent healthcare use and potential overlap with the StressModex intervention, and estimate parameters relevant to the sample size calculation for a future definitive RCT. Intervention fidelity, adherence, acceptability, safety, and practical aspects of intervention delivery will additionally be monitored. Clinical outcomes, including neck-related disability, pain, psychological symptoms, quality of life, and physical activity, will be collected primarily to assess the feasibility and completeness of outcome data collection and, where relevant, to estimate parameters required to inform the design of a future definitive RCT. Register-based data on healthcare utilisation, medication use, and work participation will also be collected to inform procedures and the design of a future health-economic evaluation. The pilot trial is not powered to evaluate clinical effectiveness, and no confirmatory between-group effectiveness testing is planned. Participants will be followed for six months after randomisation.