Objective There are few effective treatments for acute whiplash-associated disorders (WAD). Early symptoms of postinjury stress predict poor recovery. This randomised controlled trial (StressModex) investigated whether physiotherapist-led stress inoculation training integrated with exercise is more effective than exercise alone for people with acute WAD.
Methods 108 participants (<4 weeks) at risk of poor recovery (moderate pain-related disability and hyperarousal symptoms) were randomly assigned by concealed allocation to either physiotherapist-led stress inoculation training and guideline-based exercise (n=53) or guideline-based exercise alone (n=55). Both interventions comprised 10 sessions over 6 weeks. Participants were assessed at 6 weeks and at 6 and 12 months postrandomisation. Analysis was by intention to treat using linear mixed models.
Results The combined stress inoculation training and exercise intervention was more effective than exercise alone for the primary outcome of pain-related disability at all follow-up points. At 6 weeks, the treatment effect on the 0–100 Neck Disability Index was (mean difference) −10 (95% CI −15.5 to −4.48), at 6 months was −7.8 (95% CI −13.8 to −1.8) and at 12 months was −10.1 (95% CI −16.3 to −4.0). A significant benefit of the stress inoculation and exercise intervention over exercise alone was also found for some secondary outcomes.
Conclusion A physiotherapist-led intervention of stress inoculation training and exercise resulted in clinically relevant improvements in disability compared with exercise alone—the most commonly recommended treatment for acute WAD. This contributes to the case for physiotherapists to deliver an early psychological intervention to patients with acute WAD who are otherwise at high risk of a poor outcome.
Trial registration number ACTRN12614001036606.
- exercise rehabilitation
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Contributors MS contributed to the study conception and design, training and auditing of the physiotherapists, recruitment of participants, data management and the drafting and revision of the manuscript. RS and JK contributed to the study conception and design, training and auditing of the physiotherapists and the revision of the manuscript. GK contributed to the recruitment of participants and revision of the manuscript. JW contributed to the data management, data analysis and drafting and revision of the manuscript. MS and JW act as guarantors and take responsibility for the integrity of the data and the accuracy of the data analysis. The corresponding author attests that all listed authors meet the authorship criteria and that no others meeting the criteria have been omitted. The senior author (MS) affirms that the manuscript is an honest, accurate and transparent account of the study being reported, that no aspects of the study have been omitted and that any discrepancies from the study as planned/registered have been explained.
Funding The trial was funded by the National Health and Medical Research Council of Australia (Grant ID: APP1069443). The funders of the study had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; and preparation, review or approval of the manuscript or the decision to submit for publication.
Competing interests None declared.
Ethics approval Ethical approval was obtained from the human ethics research committees of The University of Queensland (2011000206), Griffith University (AHS/14/14/HREC) and the Gold Coast University Hospital (HREC/15/QGC/34). All participants gave written informed consent prior to study entry.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The investigators will share data (with associated coding library) used in developing the results presented in this manuscript on request to the corresponding author at firstname.lastname@example.org. Anonymised record-level data will be made available on proposal for analysis by those who have received ethical clearance from their host institution.
Correction notice This article has been corrected since it published Online First. The CI −15.5 to −9.0 has been corrected to −15.5 to −4.48 in the abstract, results and table 4.
Patient consent for publication Not required.