Whiplash-associated DisordersNCT06580990
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
A study testing specific neck exercises with the Spinetrack and specific neck exercises in people with Whiplash-associated Disorders, run by Universidad de Concepcion at 1 site in Chile.
Trial summary
Whiplash-associated disorders (WAD) are common injuries from motor vehicle accidents, typically treated with a return to normal activity and neck exercises. The Spinetrack device has been approved for deep neck musculature training, but its impact on pain and disability in subacute WAD patients in a virtual setting… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Whiplash-associated Disorders
- What is being tested?
- specific neck exercises with the Spinetrack and specific neck exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChile
- Study dates
- 29 Oct 2024to Nov 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 years
- Patients with WAD, defined as cervical pain or disability resulting from a resulting from a collision or similar trauma, grade I-II according to QTF8 in subacute stage from 7 days to 12 weeks.
- Have internet connection and a device to communicate (telephone, television, computer).
- NPRS up to moderate category (4 out of 10).38
- IDC score up to moderate category (15 out of 50).
Who cannot join
- Screening for cervical fractures ruled out by the National Emergency X-ray Utilization Study (NEXUS) criteria. (Focal neurological deficits such as paralysis, paraesthesia, speech, vision or hearing impairment; Midline spinal cord tenderness; Altered spinal cord level Altered level of consciousness; Intoxication; Distraction injury defined as a serious injury to another part of the body; or other serious injury to another part of the body that could distract from the neck injury).
- Previous cervical spine, jaw and upper extremity surgeries
- Traumatic brain injury
- Neck pain and disability from abuse, domestic violence or fights
- Difficulty hearing and understanding instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Telerehabilitation Programme Based on Specific Neck Specific Neck Exercises in Patients With Whiplash-associated Disorders. Randomised Clinical Trial Controlled and Multicentric
Whiplash-associated disorders (WAD) are common injuries from motor vehicle accidents, typically treated with a return to normal activity and neck exercises. The Spinetrack device has been approved for deep neck musculature training, but its impact on pain and disability in subacute WAD patients in a virtual setting hasn't been evaluated yet. This study aims to assess the effect of a telerehabilitation programme using the Spinetrack device on pain and self-perceived disability in subacute WAD I and II patients. The single-blinded, randomised, controlled clinical trial will involve 102 participants divided into three groups: a telerehabilitation group using Spinetrack, a group with a standard telerehabilitation programme, and a usual care group. Training will be conducted via video call for six weeks. The study expects to confirm that deep neck musculature training reduces pain and disability in WAD patients and establish Spinetrack as an efficient tool for subacute WAD treatment.
Read the detailed description
Introduction: Whiplash-associated disorders (WAD) are a group of clinical manifestations experienced by individuals following a sudden acceleration-deceleration mechanism of the neck. WAD are the most common injuries resulting from a motor vehicle accident. The mainstays of WAD treatment are a return to normal activity and both general and deep neck musculature exercises. Recently, a device called Spinetrack has been validated to facilitate training of the deep craniocervical musculature. This device can even be adapted for use in a virtual format. However, to date, it has not been determined how this device contributes to the improvement of pain and disability in individuals with subacute WAD in a virtual context.
Objective: The aim of this study is to evaluate the effect of a telerehabilitation programme, which is based on specific neck exercises with the Spinetrack, on pain and self-perceived disability in people with WAD I and II in the subacute stage.
Methods: This study is a single-blinded, randomised, controlled clinical trial. A total of 102 subjects with WAD I and II will be recruited according to the Quebec Task Force classification in the subacute stage. The participants will be randomised into three groups: a telerehabilitation group based on specific neck exercises with the Spinetrack (SES), a treatment group with a telerehabilitation programme with standard specific neck exercises (SSE), and a usual care group (UCG).
Training will be carried out via video call over 12 sessions distributed over six weeks, with two sessions per week. The main outcome variables will be pain and perceived disability.
Expected Results: The investigators anticipate that training the deep neck musculature will reduce pain and disability in patients with WAD. It is expected to demonstrate the device's function as a tool for self-management of neck symptoms and to provide the health care system with an efficient device for the treatment of subacute WAD.
- Conditions
- Whiplash-associated Disorders
- Being tested
- specific neck exercises with the Spinetrack, specific neck exercises
- Keywords
- Whiplash, Exercise, Pain, Disability, Telerehabilitation
- Medical subject headings
- Whiplash Injuries, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific neck exercises with the SpinetrackProcedure or surgery
Also called SES
This group will receive an telerehabilitation exercise programme for the deep neck musculature using the spinetrack
specific neck exercisesProcedure or surgery
Also called SSE
This group will receive a telerehabilitation programme with exercise for the deep neck musculature
| Study group | Role | What they receive |
|---|---|---|
| Specific neck exercises with the Spinetrack | Experimental | Exercise the deep neck muscles using the Spinetrak twice a week for 6 weeks. Receives: Procedure: specific neck exercises with the Spinetrack |
| Standard specific neck exercises | Active comparator | Exercise programme for the deep neck musculature twice a week for 6 weeks. Receives: Procedure: specific neck exercises |
| Usual care group | No intervention | This group will receive instructions from the doctor based on their assessment, taking into account education and analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity as measured by Numeric Pain Rating Scale (NPRS)
NPRS is a validated instrument assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no pain) to (wort possible pain).
Measured: Baseline, at 6 and 12 weeks
Disability as measured by Neck disability Index (NDI)
This questionnaire has been validated to give information as to how the neck pain has affected the ability to manage in everyday life.The original report provided scoring intervals for interpretation, as follows: 0 to 4 = no disability 5 to 14 = mild 15 to 24 = moderate 25 to 34 = severe Above 34 = complete.
Measured: Baseline, at 6 and 12 weeks
Secondary outcomes (8)
Global Perceived Effect as measured by Global Perceived Effect Scale (-7 to +7 Likert Scale)
The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter. Patients are routinely asked to make global ratings on changes in regards to their level of well-being since the previous week's treatment on a 15-point self-report scale (from -7 to 7)
Measured: Baseline, at 6 and 12 weeks
Self-perception of vestibular difficulty as measured by Dizziness Handicap Inventory (DHI)
The DHI is a 25-item self-reported measure with three categories: functional, emotional, and physical. The patient rates their perceived disability due to their dizziness by answering each question with - yes, sometimes, or no.
Measured: Baseline, at 6 and 12 weeks
dizziness induced by dynamic visual input as measured by Visual vertigo analogue scale (VVAS)
Vertigo symptoms that are triggered by visual stimuli. Scale have 9 items and each one is answered from 0 (no vertigo) to 10 (maximum vertigo).
Measured: Baseline, at 6 and 12 weeks
Impact of headaches on daily life Headache intensity as measured by The Headache Impact Test (HIT-6)
HIT-6 is a questionnaire for measuring the impact of headache. A total of six questions are completed by the patient. They focus on daily activities such as work, education, home situation and leisure time. The HIT-6 gives a general overview of the impact of headache, including pain intensity, impairment and other items. A higher score corresponds to higher impact.
Measured: Baseline, at 6 and 12 weeks
Fear or excessive aversion to physical movement or exercise, also called kinesiophobia as measured by Tampa Scale of Kinesiophobia (TSK)
The TSK is a 17 item assessment checklist. It uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury
Measured: Baseline, at 6 and 12 weeks
depression and anxiety as measured by Hospital Anxiety and Depression Scale (HADS)
The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21)
Measured: Baseline, at 6 and 12 weeks
Difficulties people sometimes have after stressful life events as measured by Impacto of event scale (IES)
Post-traumatic stress disorder (PTSD) symptoms. Event Impact Scale-Revised has 22 items and 3 subscales: Intrusion, Avoidance and Hyperarousal. It uses a Likert-type scale to evaluate the intensity of the of the symptomatology (0,1,2,2,3,4. From 'Not at all' to 'Extremely').
to 'Extremely')
Measured: Baseline, at 6 and 12 weeks
Measures the somatic and emotional symptoms common to central sensitization syndrome (CSS) as measured by the Central Sensitization Inventory (CSI)
Pathophysiologic process in which the central nervous system undergoes changes that alter its processing of pain and other sensory stimuli, may be the mechanism underlying various conditions in which patients have unexplained pain and fatigue. The CSI consists of two parts; Part A includes 25 questions related to common CSS symptoms. Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression.
Measured: Baseline, at 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start29 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whiplash-associated DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a single-blinded, randomised, controlled clinical trial and multicentric
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Concepcion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Muñoz Bustos, Universidad de Concepcion
- Investigators
- Mario Muñoz Bustos, MSc, Principal investigator, Universidad de Concepcion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580990
- Sponsor's protocol ID
- CEBB 1682-2024
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munoz Bustos M, Niera Torres H, Ceballos-Laita L, Munoz-Bustos GA, Portela A, Carrasco-Uribarren A. Effects of device-guided craniocervical muscle training in subacute whiplash: a preliminary randomized controlled trial. J Man Manip Ther. 2026 Aug 29:1-12. doi: 10.1080/10669817.2026.2720771. Online ahead of print.
PubMed 42667605
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Telerehabilitation Programme Based on Specific Neck Specific Neck Exercises in Patients With Whiplash-associated Disorders. Randomised Clinical Trial Controlled and Multicentric
- ClinicalTrials.gov ID
- NCT06580990
- Acronym / sponsor ID
- CEBB 1682-2024
- Conditions
- Whiplash-associated Disorders
- Keywords
- Whiplash, Exercise, Pain, Disability, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Universidad de ConcepcionUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 Aug 2024 (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.
Whiplash-associated disorders (WAD) are common injuries from motor vehicle accidents, typically treated with a return to normal activity and neck exercises. The Spinetrack device has been approved for deep neck musculature training, but its impact on pain and disability in subacute WAD patients in a virtual setting hasn't been evaluated yet. This study aims to assess the effect of a telerehabilitation programme using the Spinetrack device on pain and self-perceived disability in subacute WAD I and II patients. The single-blinded, randomised, controlled clinical trial will involve 102 participants divided into three groups: a telerehabilitation group using Spinetrack, a group with a standard telerehabilitation programme, and a usual care group. Training will be conducted via video call for six weeks. The study expects to confirm that deep neck musculature training reduces pain and disability in WAD patients and establish Spinetrack as an efficient tool for subacute WAD treatment.
Detailed description
Introduction: Whiplash-associated disorders (WAD) are a group of clinical manifestations experienced by individuals following a sudden acceleration-deceleration mechanism of the neck. WAD are the most common injuries resulting from a motor vehicle accident. The mainstays of WAD treatment are a return to normal activity and both general and deep neck musculature exercises. Recently, a device called Spinetrack has been validated to facilitate training of the deep craniocervical musculature. This device can even be adapted for use in a virtual format. However, to date, it has not been determined how this device contributes to the improvement of pain and disability in individuals with subacute WAD in a virtual context.
Objective: The aim of this study is to evaluate the effect of a telerehabilitation programme, which is based on specific neck exercises with the Spinetrack, on pain and self-perceived disability in people with WAD I and II in the subacute stage.
Methods: This study is a single-blinded, randomised, controlled clinical trial. A total of 102 subjects with WAD I and II will be recruited according to the Quebec Task Force classification in the subacute stage. The participants will be randomised into three groups: a telerehabilitation group based on specific neck exercises with the Spinetrack (SES), a treatment group with a telerehabilitation programme with standard specific neck exercises (SSE), and a usual care group (UCG).
Training will be carried out via video call over 12 sessions distributed over six weeks, with two sessions per week. The main outcome variables will be pain and perceived disability.
Expected Results: The investigators anticipate that training the deep neck musculature will reduce pain and disability in patients with WAD. It is expected to demonstrate the device's function as a tool for self-management of neck symptoms and to provide the health care system with an efficient device for the treatment of subacute WAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study will be a single-blinded, randomised, controlled clinical trial and multicentric
| Arm | Type | Receives |
|---|---|---|
| Specific neck exercises with the Spinetrack | Experimental | Procedure: specific neck exercises with the SpinetrackExercise the deep neck muscles using the Spinetrak twice a week for 6 weeks. |
| Standard specific neck exercises | Active comparator | Procedure: specific neck exercisesExercise programme for the deep neck musculature twice a week for 6 weeks. |
| Usual care group | No intervention | –This group will receive instructions from the doctor based on their assessment, taking into account education and analgesics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18-65 years
- Patients with WAD, defined as cervical pain or disability resulting from a resulting from a collision or similar trauma, grade I-II according to QTF8 in subacute stage from 7 days to 12 weeks.
- Have internet connection and a device to communicate (telephone, television, computer).
- NPRS up to moderate category (4 out of 10).38
- IDC score up to moderate category (15 out of 50).
Key exclusion criteria (5 listed)
- Screening for cervical fractures ruled out by the National Emergency X-ray Utilization Study (NEXUS) criteria. (Focal neurological deficits such as paralysis, paraesthesia, speech, vision or hearing impairment; Midline spinal cord tenderness; Altered spinal cord level Altered level of consciousness; Intoxication; Distraction injury defined as a serious injury to another part of the body; or other serious injury to another part of the body that could distract from the neck injury).
- Previous cervical spine, jaw and upper extremity surgeries
- Traumatic brain injury
- Neck pain and disability from abuse, domestic violence or fights
- Difficulty hearing and understanding instructions
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 |
|---|---|---|
| specific neck exercises with the SpinetrackAlso: SESThis group will receive an telerehabilitation exercise programme for the deep neck musculature using the spinetrack | Procedure or surgery | Specific neck exercises with the Spinetrack |
| specific neck exercisesAlso: SSEThis group will receive a telerehabilitation programme with exercise for the deep neck musculature | Procedure or surgery | Standard specific neck exercises |
Primary outcome
Pain intensity as measured by Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, at 6 and 12 weeks
NPRS is a validated instrument assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no pain) to (wort possible pain).
Disability as measured by Neck disability Index (NDI)
Time frame: Baseline, at 6 and 12 weeks
This questionnaire has been validated to give information as to how the neck pain has affected the ability to manage in everyday life.The original report provided scoring intervals for interpretation, as follows: 0 to 4 = no disability 5 to 14 = mild 15 to 24 = moderate 25 to 34 = severe Above 34 = complete.
8 secondary outcomes
Global Perceived Effect as measured by Global Perceived Effect Scale (-7 to +7 Likert Scale)
Time frame: Baseline, at 6 and 12 weeks
Self-perception of vestibular difficulty as measured by Dizziness Handicap Inventory (DHI)
Time frame: Baseline, at 6 and 12 weeks
dizziness induced by dynamic visual input as measured by Visual vertigo analogue scale (VVAS)
Time frame: Baseline, at 6 and 12 weeks
Impact of headaches on daily life Headache intensity as measured by The Headache Impact Test (HIT-6)
Time frame: Baseline, at 6 and 12 weeks
Fear or excessive aversion to physical movement or exercise, also called kinesiophobia as measured by Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline, at 6 and 12 weeks
depression and anxiety as measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, at 6 and 12 weeks
Difficulties people sometimes have after stressful life events as measured by Impacto of event scale (IES)
Time frame: Baseline, at 6 and 12 weeks
Measures the somatic and emotional symptoms common to central sensitization syndrome (CSS) as measured by the Central Sensitization Inventory (CSI)
Time frame: Baseline, at 6 and 12 weeks
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 6 Oct 2026.
- Derived from this study: PubMed 42667605Munoz Bustos M, Niera Torres H, Ceballos-Laita L, Munoz-Bustos GA, Portela A, Carrasco-Uribarren A. Effects of device-guided craniocervical muscle training in subacute whiplash: a preliminary randomized controlled trial. J Man Manip Ther. 2026 Aug 29:1-12. doi: 10.1080/10669817.2026.2720771. Online ahead of print.
- Individual participant dataSharing planned: No
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Manipulation and Dry Needling in Patients With Cervicogenic Headache and WAD II
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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. This study is not recruiting at the moment.
Mario Muñoz Bustos, MSc principal investigator
Universidad de Concepcion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific neck exercises with the Spinetrack and specific neck exercises in people with Whiplash-associated Disorders, run by Universidad de Concepcion at 1 site in Chile.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity as measured by Numeric Pain Rating Scale (NPRS) (time frame: Baseline, at 6 and 12 weeks). 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 NCT06580990, which also lists 1 linked publication.
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 6 Oct 2026.