StressModex for Post-Traumatic Neck Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern Denmark
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
StressModex plus Treatment as Usual
BehavioralStressModex 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: StressModex plus Treatment as UsualExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate
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).
Time frame
Throughout the active recruitment period, up to 10 months2
Participant retention at 6-month follow-up
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).
Time frame
6 months after randomisationSecondary outcomes
1
Participant retention at 6-week and 3-month follow-up
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.
Time frame
6 weeks and 3 months after randomisation2
Completeness of remotely collected outcome data
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.
Time frame
Baseline, 6 weeks, 3 months, and 6 months3
Acceptance of 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
Time frame
At enrolment, prior to randomisation4
Withdrawal following treatment allocation
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.
Time frame
From randomisation to 6-month follow-upOther outcomes
1
Pain intensity
Pain intensity during the previous 24 hours will be measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Time frame
Baseline, 6 weeks, 3 months, and 6 months2
Post-traumatic stress symptoms
Post-traumatic stress symptoms will be assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). The total score ranges from 0 to 80, with higher scores indicating greater post-traumatic stress symptom severity and therefore a worse outcome.
Time frame
Baseline, 6 weeks, 3 months, and 6 months3
Hyperarousal symptoms
Hyperarousal symptoms will be assessed using the hyperarousal subscale of the Posttraumatic Diagnostic Scale (PDS). The subscale score ranges from 0 to 15, with higher scores indicating greater hyperarousal symptom severity.
Time frame
Baseline, 6 weeks, 3 months, and 6 months4
Depression, anxiety, and stress symptoms
Symptoms of depression, anxiety, and stress will be assessed using the 21-item Depression Anxiety Stress Scales (DASS-21). The instrument comprises three subscales: depression, anxiety, and stress. Each subscale score ranges from 0 to 42, with higher scores indicating greater symptom severity
Time frame
Baseline, 6 weeks, 3 months, and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern Denmark
Lead sponsor
Slagelse Hospital
Collaborator
The Research and Implementation Unit PROgrez, Region Zealand,Denmark
Collaborator
University College South Denmark
Collaborator
Hospital of Southern Jutland
Collaborator
Specialized Hospital for Polio and Accident Victims, Rødovre, Denmark
Collaborator
Spine Centre of Southern Denmark
Collaborator
Source ClinicalTrials.gov
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