Early Stratified Physiotherapy Combined With Stress Inoculation Training for Individuals at Risk of Persistent Post-Traumatic Neck Pain: A Randomized Pilot Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Due to the nature of the intervention, participants and treating physiotherapists cannot be blinded to treatment allocation. Statistical analyses will be conducted by a statistician blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Post-traumatic neck pain with symptom duration of less than 6 months
- •Moderate neck-related disability, defined as Neck Disability Index (NDI) score ≥32%
- •Hyperarousal symptoms defined as a score of ≥3 on the hyperarousal subscale of the Posttraumatic Diagnostic Scale (PDS)
- •Able to read, understand, and communicate in Danish
排除标准
- •Known or suspected spinal pathology, including confirmed fracture or vertebral displacement related to the injury
- •Severe pre-existing pain condition judged to interfere with participation in the intervention, such as disc herniation, fractures, or recent major surgery
- •Known severe psychiatric disorder, including schizophrenia spectrum disorder or bipolar disorder, if the condition is currently considered unstable, insufficiently treated, or likely to affect the participant's ability to provide informed consent or participate meaningfully in the study
- •Known active misuse of alcohol, illicit drugs, anxiolytic medication, or opioids
- •Progressive neurological or rheumatological disorder causing substantial functional limitations and expected to interfere with participation in the intervention or assessment of treatment effect
- •Severe traumatic brain injury
研究组 & 干预措施
StressModex plus Treatment as Usual
Participants allocated to this arm will receive StressModex in addition to treatment as usual (TAU). StressModex comprises 10 physiotherapy sessions delivered over six weeks and combines individually tailored, guideline-based physiotherapy with Stress Inoculation Training (SIT). SIT is integrated into six of the 10 sessions. Participants remain free to seek additional healthcare according to usual Danish practice throughout the study period.
干预措施: StressModex plus Treatment as Usual (Behavioral)
Treatment as Usual
Participants allocated to this arm will not receive the StressModex intervention. They will continue with treatment as usual and remain free to seek healthcare according to usual Danish practice, including consultation with their general practitioner and treatment from other healthcare providers as considered necessary.
结局指标
主要结局
Recruitment rate
时间窗: 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
时间窗: 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).
次要结局
- Participant retention at 6-week and 3-month follow-up(6 weeks and 3 months after randomisation)
- Completeness of remotely collected outcome data(Baseline, 6 weeks, 3 months, and 6 months)
- Intervention adherence and completion(Throughout the 6-week intervention period)
- Acceptance of randomisation(At enrolment, prior to randomisation)
- Withdrawal following treatment allocation(From randomisation to 6-month follow-up)
- Treatment as usual and concurrent healthcare use(Baseline, 6 weeks, 3 months, and 6 months)
- Intervention fidelity(Throughout the 6-week intervention period)
- Acceptability of the StressModex intervention(6 weeks, 3 months and 6 months after randomisation)
- Clinician perspectives on intervention delivery and implementation(Following intervention delivery)
- Variability of Neck Disability Index score to inform a future definitive RCT(Baseline, 6 weeks, 3 months, and 6 months)