Post-Traumatic Neck Pain, Whiplash-associated Disorders
Conditions
Keywords
Whiplash, Neck Pain, Post-Traumatic Stress, Hyperarousal, Stress Inoculation Training, Psychologically Informed Physiotherapy, Physiotherapy, Musculoskeletal Pain, Randomized Pilot Trial
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALStressModex 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.
Sponsors
University of Southern Denmark
Slagelse Hospital
The Research and Implementation Unit PROgrez, Region Zealand,Denmark
University College South Denmark
Hospital of Southern Jutland
Specialized Hospital for Polio and Accident Victims, Rødovre, Denmark
Spine Centre of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either StressModex (physiotherapy combined with stress inoculation training) in addition to TAU or solely TAU.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant retention at 6-week and 3-month follow-up | 6 weeks and 3 months after randomisation | Retention will be assessed as the proportion of randomised participants retained at each follow-up time point. Reasons for withdrawal or loss to follow-up will be recorded where available. |
| Completeness of remotely collected outcome data | Baseline, 6 weeks, 3 months, and 6 months | Completeness of remotely collected outcome data will be assessed at each time point. The proportion of participants providing complete NDI data will be reported separately, as NDI is the proposed primary clinical outcome for a future definitive RCT. NDI data completeness of ≥80% will be considered acceptable, 70 to \<80% will indicate that modifications to data collection procedures should be considered, and \<70% will indicate substantial feasibility concerns. Completeness of the remaining questionnaire battery will also be described. |
| Acceptance of randomisation | At enrolment, prior to randomisation | Acceptance of randomisation will be assessed as the proportion of eligible individuals invited to participate in the trial who provide informed consent to participation and randomisation. Reasons for declining participation will be recorded where available. Acceptance of ≥80% will be considered acceptable, 60 to \<80% will indicate that modifications to recruitment or trial information procedures should be considered, and \<60% will indicate substantial concerns regarding the feasibility of the randomised design |
| Withdrawal following treatment allocation | From randomisation to 6-month follow-up | The proportion of randomised participants who withdraw from the study following treatment allocation will be assessed by trial arm. Reasons for withdrawal, including reasons related to treatment allocation, will be recorded where available. |
| Treatment as usual and concurrent healthcare use | Baseline, 6 weeks, 3 months, and 6 months | Healthcare use will be assessed by participant report, including the type and extent of healthcare received and medication use. Data will be used to characterise treatment as usual and concurrent healthcare use in both trial arms and to identify potential overlap between usual care and components of StressModex. |
| Intervention fidelity | Throughout the 6-week intervention period | Intervention fidelity will be assessed using therapist-completed standardised checklists after each treatment session, documenting delivery of the core StressModex intervention components. Fidelity will be summarised as the proportion of planned core intervention components delivered as intended. |
| Intervention adherence and completion | Throughout the 6-week intervention period | Intervention adherence will be assessed based on initiation and completion of the intervention, attendance at scheduled treatment sessions, and participant-reported adherence to prescribed home exercises. Treatment attendance will be summarised as the proportion of scheduled sessions attended. |
| Acceptability of the StressModex intervention | 6 weeks, 3 months and 6 months after randomisation | Acceptability of the StressModex intervention will be explored among participants allocated to the intervention through semi-structured interviews. Interviews will address participants' experiences of the intervention, including perceived relevance, burden, barriers and facilitators to participation, application in everyday life, and practical aspects of treatment delivery, as well as their general reflections also on symptom development. |
| Clinician perspectives on intervention delivery and implementation | Following intervention delivery | Clinicians delivering StressModex will participate in semi-structured interviews exploring experiences of intervention delivery, implementation, barriers, facilitators, and practical considerations relevant to a future definitive RCT. |
| Variability of Neck Disability Index score to inform a future definitive RCT | Baseline, 6 weeks, 3 months, and 6 months | Neck-related disability will be measured using the Neck Disability Index (NDI). The variability of NDI scores will be estimated to provide trial-specific information for refinement of the sample size calculation for a future definitive RCT. Estimates will be interpreted alongside relevant external evidence and will not be used for confirmatory effectiveness testing |
Countries
Denmark
Contacts
CONTACTRené B Jørgensen, Msc
PRINCIPAL_INVESTIGATORRené B Jørgensen, Msc
University of Southern Denmark
Outcome results
None listed