StressModex for Post-Traumatic Neck Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

StressModex plus Treatment as Usual: StressModex is a physiotherapist-delivered intervention combining guideline-based exercise therapy with stress inoculation training. Participants receive 10 treatment sessions over six weeks. Exercise components target neck mobility, strength, endurance, and sensorimotor function. Stress inoculation training components are integrated into six sessions and focus on stress education, relaxation strategies, coping skills, and self-management of stress-related symptoms following trauma.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Recruitment rate — Throughout the active recruitment period, up to 10 months
  Recruitment rate will be assessed as the number of participants randomised per month during the active recruitment period. Recruitment will be evaluated against prespecified progression criteria: ≥5 participants per month (go), 3 to \<5 participants per month (amend), and \<3 participants per month (stop/reconsider).
• Participant retention at 6-month follow-up — 6 months after randomisation
  Retention will be assessed as the proportion of randomised participants retained at the 6-month follow-up. Retention will be evaluated against prespecified progression criteria: ≥75% retention (go), 50 to \<75% retention (amend), and \<50% retention (stop/reconsider).

Trial sites (3)

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