Post-Traumatic Neck PainStressModexNCT07824557
StressModex for Post-Traumatic Neck Pain
A study testing StressModex plus Treatment as Usual in people with Post-Traumatic Neck Pain and Whiplash-associated Disorders, run by University of Southern Denmark at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Neck Pain, Whiplash-associated Disorders
- What is being tested?
- StressModex plus Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesDenmark
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites
Hospital of Southern Jutland
Aabenraa
Marinna B Cartuliares, Ph.d., +45 23434441, mbc@rsyd.dk
Specialized Hospital for Polio and Accident Victims
Rødovre Municipality
Sophie L Ravn, Associate Professor, +4526819022, slravn@health.sdu.dk
Central and West Zealand Hospital
Slagelse
Søren T Schou, Professor, +45 23 70 86 40, stskou@health.sdu.dk
About this study
Official title: Early Stratified Physiotherapy Combined With Stress Inoculation Training for Individuals at Risk of Persistent Post-Traumatic Neck Pain: A Randomized Pilot 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.
Read the 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.
- Being tested
- StressModex plus Treatment as Usual
- Keywords
- Whiplash, Neck Pain, Post-Traumatic Stress, Hyperarousal, Stress Inoculation Training, Psychologically Informed Physiotherapy, Physiotherapy, Musculoskeletal Pain, Randomized Pilot Trial
- Medical subject headings
- Whiplash Injuries, Neck Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StressModex plus Treatment as UsualBehavioural
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 group | Role | What they receive |
|---|---|---|
| StressModex plus Treatment as Usual | Experimental | 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. Receives: Behavioral: StressModex plus Treatment as Usual |
| Treatment as Usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Throughout the active recruitment period, up to 10 months
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).
Measured: 6 months after randomisation
Secondary outcomes (10)
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.
Measured: 6 weeks and 3 months after randomisation
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.
Measured: Baseline, 6 weeks, 3 months, and 6 months
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
Measured: At enrolment, prior to randomisation
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.
Measured: From randomisation to 6-month follow-up
Treatment as usual and concurrent healthcare use
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.
Measured: Baseline, 6 weeks, 3 months, and 6 months
Intervention fidelity
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.
Measured: Throughout the 6-week intervention period
Intervention adherence and completion
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.
Measured: Throughout the 6-week intervention period
Acceptability of the StressModex intervention
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.
Measured: 6 weeks, 3 months and 6 months after randomisation
Clinician perspectives on intervention delivery and implementation
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.
Measured: Following intervention delivery
Variability of Neck Disability Index score to inform a future definitive RCT
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
Measured: Baseline, 6 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- René B Jørgensen, Msc, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824557
- Sponsor's protocol ID
- S20260024
- Acronym
- StressModex
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team has not yet made a final decision regarding the sharing of de-identified individual participant data. Any future data sharing will be conducted in accordance with applicable data protection regulations, institutional policies, and ethical approvals.
Publications
Willaert W, Leysen L, Lenoir D, Meeus M, Cagnie B, Nijs J, Sterling M, Coppieters I. Combining Stress Management With Pain Neuroscience Education and Exercise Therapy in People With Whiplash-Associated Disorders: A Clinical Perspective. Phys Ther. 2021 Jul 1;101(7):pzab105. doi: 10.1093/ptj/pzab105.
PubMed 33764474Coronado RA, Brintz CE, McKernan LC, Master H, Motzny N, Silva FM, Goyal PM, Wegener ST, Archer KR. Psychologically informed physical therapy for musculoskeletal pain: current approaches, implications, and future directions from recent randomized trials. Pain Rep. 2020 Sep 23;5(5):e847. doi: 10.1097/PR9.0000000000000847. eCollection 2020 Sep-Oct.
PubMed 33490842Ritchie C, Hendrikz J, Jull G, Elliott J, Sterling M. External validation of a clinical prediction rule to predict full recovery and ongoing moderate/severe disability following acute whiplash injury. J Orthop Sports Phys Ther. 2015 Apr;45(4):242-50. doi: 10.2519/jospt.2015.5642.
PubMed 25827122Ritchie C, Hendrikz J, Kenardy J, Sterling M. Derivation of a clinical prediction rule to identify both chronic moderate/severe disability and full recovery following whiplash injury. Pain. 2013 Oct;154(10):2198-2206. doi: 10.1016/j.pain.2013.07.001. Epub 2013 Jul 4.
PubMed 23831865Sterling M, Smeets R, Keijzers G, Warren J, Kenardy J. Physiotherapist-delivered stress inoculation training integrated with exercise versus physiotherapy exercise alone for acute whiplash-associated disorder (StressModex): a randomised controlled trial of a combined psychological/physical intervention. Br J Sports Med. 2019 Oct;53(19):1240-1247. doi: 10.1136/bjsports-2018-100139. Epub 2019 Jan 19.
PubMed 30661011
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Stratified Physiotherapy Combined With Stress Inoculation Training for Individuals at Risk of Persistent Post-Traumatic Neck Pain: A Randomized Pilot Trial.
- ClinicalTrials.gov ID
- NCT07824557
- Acronym / sponsor ID
- StressModex / S20260024
- Keywords
- Whiplash, Neck Pain, Post-Traumatic Stress, Hyperarousal, Stress Inoculation Training, Psychologically Informed Physiotherapy, Physiotherapy, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- 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 start
- Sep 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| StressModex plus Treatment as Usual | Experimental | Behavioral: StressModex plus Treatment as UsualParticipants 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. |
| Treatment as Usual | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StressModex plus Treatment as UsualStressModex 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. | Behavioural | StressModex plus Treatment as Usual |
Primary outcome
Recruitment rate
Time frame: 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
Time frame: 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).
10 secondary outcomes
Participant retention at 6-week and 3-month follow-up
Time frame: 6 weeks and 3 months after randomisation
Completeness of remotely collected outcome data
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Acceptance of randomisation
Time frame: At enrolment, prior to randomisation
Withdrawal following treatment allocation
Time frame: From randomisation to 6-month follow-up
Treatment as usual and concurrent healthcare use
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Intervention fidelity
Time frame: Throughout the 6-week intervention period
Intervention adherence and completion
Time frame: Throughout the 6-week intervention period
Acceptability of the StressModex intervention
Time frame: 6 weeks, 3 months and 6 months after randomisation
Clinician perspectives on intervention delivery and implementation
Time frame: Following intervention delivery
Variability of Neck Disability Index score to inform a future definitive RCT
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 33764474Willaert W, Leysen L, Lenoir D, Meeus M, Cagnie B, Nijs J, Sterling M, Coppieters I. Combining Stress Management With Pain Neuroscience Education and Exercise Therapy in People With Whiplash-Associated Disorders: A Clinical Perspective. Phys Ther. 2021 Jul 1;101(7):pzab105. doi: 10.1093/ptj/pzab105.
- Background: PubMed 33490842Coronado RA, Brintz CE, McKernan LC, Master H, Motzny N, Silva FM, Goyal PM, Wegener ST, Archer KR. Psychologically informed physical therapy for musculoskeletal pain: current approaches, implications, and future directions from recent randomized trials. Pain Rep. 2020 Sep 23;5(5):e847. doi: 10.1097/PR9.0000000000000847. eCollection 2020 Sep-Oct.
- Background: PubMed 25827122Ritchie C, Hendrikz J, Jull G, Elliott J, Sterling M. External validation of a clinical prediction rule to predict full recovery and ongoing moderate/severe disability following acute whiplash injury. J Orthop Sports Phys Ther. 2015 Apr;45(4):242-50. doi: 10.2519/jospt.2015.5642.
- Background: PubMed 23831865Ritchie C, Hendrikz J, Kenardy J, Sterling M. Derivation of a clinical prediction rule to identify both chronic moderate/severe disability and full recovery following whiplash injury. Pain. 2013 Oct;154(10):2198-2206. doi: 10.1016/j.pain.2013.07.001. Epub 2013 Jul 4.
- Background: PubMed 30661011Sterling M, Smeets R, Keijzers G, Warren J, Kenardy J. Physiotherapist-delivered stress inoculation training integrated with exercise versus physiotherapy exercise alone for acute whiplash-associated disorder (StressModex): a randomised controlled trial of a combined psychological/physical intervention. Br J Sports Med. 2019 Oct;53(19):1240-1247. doi: 10.1136/bjsports-2018-100139. Epub 2019 Jan 19.
- Individual participant dataSharing planned: Undecided. The study team has not yet made a final decision regarding the sharing of de-identified individual participant data. Any future data sharing will be conducted in accordance with applicable data protection regulations, institutional policies, and ethical approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
René B Jørgensen, Msc principal investigator
University of Southern Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StressModex plus Treatment as Usual in people with Post-Traumatic Neck Pain and Whiplash-associated Disorders, run by University of Southern Denmark at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact René B Jørgensen, Msc (+45 21768003, reneb@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Throughout the active recruitment period, up to 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07824557, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.