StressModex for Post-Traumatic Neck Pain

NCT07824557 | Not Yet Recruiting

• 1 other identifier: S20260024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Post-Traumatic Neck Pain; Whiplash-associated Disorders

Keywords

Whiplash; Neck Pain; Post-Traumatic Stress; Hyperarousal; Stress Inoculation Training; Psychologically Informed Physiotherapy; Physiotherapy; Musculoskeletal Pain; Randomized Pilot Trial

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  6 months after randomisation

Secondary Outcomes (10)

• 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

• 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

Other Outcomes (21)

• Pain intensity

  Baseline, 6 weeks, 3 months, and 6 months

• Post-traumatic stress symptoms

  Baseline, 6 weeks, 3 months, and 6 months

• Hyperarousal symptoms

  Baseline, 6 weeks, 3 months, and 6 months

Study Arms (2)

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.

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.

Interventions

StressModex plus Treatment as Usual BEHAVIORAL

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.

StressModex plus Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• 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

Study Sites (3)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Specialized Hospital for Polio and Accident Victims

Rødovre Municipality, Denmark

Location

Central and West Zealand Hospital

Slagelse, Denmark

Location

Related Publications (5)

• 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.

  PMID: 33764474 BACKGROUND

• Coronado 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.

  PMID: 33490842 BACKGROUND

• Ritchie 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.

  PMID: 25827122 BACKGROUND

• Ritchie 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.

  PMID: 23831865 BACKGROUND

• Sterling 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.

  PMID: 30661011 BACKGROUND

MeSH Terms

Conditions

Whiplash Injuries; Neck Pain; Musculoskeletal Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• René B Jørgensen, Msc

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

René B Jørgensen, Msc

CONTACT

+45 21768003; reneb@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-08

Locations

DK (3)