StressModEx--Physiotherapist-led Stress Inoculation Training integrated with exercise for acute whiplash injury: study protocol for a randomised controlled trial.

INTRODUCTION: Whiplash associated disorders are the most common non-hospitalised injuries following a road traffic crash. Up to 50% of individuals who experience a whiplash injury will not fully recover and report ongoing pain and disability. Most recovery, if it occurs, takes place in the first 2-3 months post injury, indicating that treatment provided in the early stages is critical to long-term outcome. However, early management approaches for people with acute whiplash associated disorders are modestly effective. One reason may be that the treatments have been non-specific and have not targeted the processes shown to be associated with poor recovery, such as post-traumatic stress symptoms. Targeting and modulating these early stress responses in the early management of acute whiplash associated disorders may improve health outcomes. Early aggressive psychological interventions in the form of psychological debriefing may be detrimental to recovery and are now not recommended for management of early post-traumatic stress symptoms. In contrast, Stress Inoculation Training (SIT) is a cognitive behavioural approach that teaches various general problem-solving and coping strategies to manage stress-related anxiety (ie, relaxation training, cognitive restructuring and positive self-statements) and provides important information to injured individuals about the impact of stress on their physical and psychological wellbeing. While referral to a psychologist may be necessary in some cases where acute stress disorder or other more significant psychological reactions to stress are evident, in the case of acute whiplash injuries, it is neither feasible nor necessary for a psychologist to deliver the early stress modulation intervention to all injured individuals. The feasibility of using other specially trained health professionals to deliver psychological interventions has been explored in conditions such as chronic low back pain, chronic whiplash and cancer, but few trials have studied this approach in acute musculoskeletal conditions with the aim of preventing the development of chronic pain. As physiotherapy is the most common intervention received by individuals with a whiplash injury, physiotherapists are ideally placed to provide SIT in conjunction with standard physical rehabilitation. This study (StressModEx) will target individuals in the acute stage of injury and address the stress responses associated with the accident or injury (event-related distress) with the aim of improving both physical and mental health outcomes.

RESEARCH QUESTION: Is SIT integrated with standard physiotherapy exercise and delivered by physiotherapists more effective than physiotherapy exercise alone in reducing neck pain and disability in individuals with acute whiplash associated disorders?

DESIGN: Parallel randomised controlled trial with blinded outcome assessment.

PARTICIPANTS AND SETTING: 100 individuals with grade II or III (no fracture/dislocation or neurological loss) acute whiplash associated disorder<4 weeks duration and at least moderate neck pain-related disability and hyper-arousal symptoms will be recruited for the study. Participants will be assessed via online surveys or in-person at a university research laboratory. Interventions will be provided at community physiotherapy practices in Brisbane, Gold Coast, Toowoomba and Mackay, Queensland, Australia.

INTERVENTION: Clinical-guideline-recommended supervised physiotherapy exercise sessions (10 sessions) integrated with six (once per week) SIT sessions.

CONTROL: Clinical-guideline-recommended supervised physiotherapy exercise sessions (10) only.

MEASUREMENTS: Primary (Neck Disability Index) and secondary (Acute Stress Disorder Scale; Post-traumatic Stress Diagnostic Scale; Depression, Anxiety and Stress Scale; Pain Catastrophisingo Scale; Pain Self-Efficacy Questionnaire; Coping Strategies Questionnaire; Global impression of recovery; pain intensity; SF36) outcomes will be measured at baseline, 6 weeks, 6 months and 12 months after randomisation.

ANALYSIS: Data analysis will be blinded and by intention to treat. Outcomes will be analysed using linear mixed and logistic regression models that will include baseline scores as covariates, participants as random effects and treatment conditions as fixed factors.

DISCUSSION: This study will be the first to address early stress responses following acute whiplash injury through a novel intervention that integrates SIT and physiotherapy exercise.