Chronic Neck PainNCT07418632
Kinematic Training in Patients With Neck Pain Based on Machine Learning Classification Approach
A study testing Smallest movement deficit training protocol, Smaller movement deficit training protocol and Larger movement deficit training group in people with Chronic Neck Pain, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
The goal of this clinical trial is to study if kinematic training based on novel kinematic assessment clasification approach can decrease chronic neck pain and prevent its reoccurance better than conventional kinematic training in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Smallest movement deficit training protocol, Smaller movement deficit training protocol and Larger movement deficit training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSlovenia
- Study dates
- 18 Mar 2026to 20 Sep 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
- presence of neck pain
- pain level minimum 3 of 10 on VAS
- did not receive conventional physiotherapy in last 6 months
Who cannot join
- any upper extremity pain within last 2 years
- any neurological or vestibular dissorders
- type 2 diabetes
- diagnosed psychiatric dissorders
- medication or alcohol consumptin in last 30 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Faculty of Sport
Ljubljana, 1000
Živa Majcen Rošker, PhD, PT, 00386 51267383, ziva.majcen-rosker@fsp.uni-lj.si
About this study
Official title: What is the Ability of Datamining Approaches to Cluster Patients With Idiopathic Neck Pain and Can Machine Learning Algorithms Provide More Efficient Rehabilitation and Less Recurrence Based on Kinaesthetic Training Protocols
The goal of this clinical trial is to study if kinematic training based on novel kinematic assessment clasification approach can decrease chronic neck pain and prevent its reoccurance better than conventional kinematic training in adults. The main question[s] it aims to answer [is/are]:
Does clustering patients with neck pain based on head and neck movement characteristics lead to more efficient kinematic rehabilitation training and improved clinical outcomes
Read more
Researchers will compare effects of cluster specific kinematic training to see if it effects pain levels and its reoccurance.
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Read the detailed description
Chronic idiopathic neck pain represents one of the most prevalent musculoskeletal conditions worldwide and is characterized by recurrent episodes, fluctuating symptom intensity, and frequent transition to persistent disability. While clinical management commonly focuses on short-term pain reduction, the more substantial societal burden arises from recurrence and chronicity rather than isolated acute episodes. Recurrent neck pain contributes to repeated healthcare consultations, prolonged work absenteeism, reduced productivity, and increasing healthcare expenditure. Despite the widespread use of exercise-based rehabilitation, recurrence rates remain high, suggesting that prevailing treatment approaches may insufficiently address the mechanisms underlying persistent dysfunction. As the prevalence of neck pain continues to rise across working-age populations, it is reasonable to question whether current rehabilitation models adequately target the neuromuscular and sensorimotor contributors to chronicity and repeated symptom exacerbations.
Most individuals presenting for physical therapy are diagnosed with non-specific or idiopathic neck pain, a broad category encompassing heterogeneous clinical presentations with variable combinations of pain, stiffness, dizziness, visual disturbances, and impaired movement control. Patients may differ substantially in movement strategies, proprioceptive acuity, neuromuscular coordination, and adaptive motor patterns, yet they are frequently managed using standardized exercise protocols. Conventional clinical assessment tools are effective in distinguishing patients from asymptomatic individuals but provide limited resolution for identifying meaningful subgroups within the idiopathic neck pain population. Over the last decade, patient-centered evaluation in spinal disorders has frequently relied on numerical pain rating scales and disability questionnaires, while comparatively less emphasis has been placed on objective assessment of neuromuscular control mechanisms that may drive chronicity. Emerging evidence demonstrates that individuals with a history of neck pain exhibit persistent alterations in sensorimotor function even during symptom remission, implying that underlying neuromuscular adaptations may predispose individuals to recurrence and reduced resilience to mechanical or psychosocial stressors.
Cervical sensorimotor control, often conceptualized as cervicocephalic kinaesthetic awareness, integrates proprioceptive input from cervical musculature and joint mechanoreceptors with visual and vestibular information to coordinate accurate head positioning and smooth eye-head movements. Altered cervical afferent input can disrupt this integration, leading to inaccurate movement perception, impaired position sense, and maladaptive motor output strategies. Prolonged proprioceptive disturbances may induce central neural plasticity changes within brainstem and cortical sensorimotor networks, potentially sustaining dysfunction beyond the initial pain episode and contributing to the maintenance of chronic symptoms. Systematic reviews report variable findings regarding the magnitude of kinaesthetic impairments in neck pain populations, likely reflecting recruitment heterogeneity, differences in symptom duration, and variability in functional deficits. These inconsistencies underscore the importance of multidimensional characterization of sensorimotor performance rather than reliance on isolated parameters or single test outcomes.
Kinaesthetic training targeting movement accuracy, proprioceptive recalibration, and coordinated motor output has demonstrated clinically meaningful short-term improvements in pain and disability, with some effects persisting for several months. However, approximately one third of patients fail to demonstrate improvement in pain intensity or disability, and nearly half do not exhibit measurable gains in objective kinematic performance variables. Additionally, dropout rates of up to twenty percent have been reported, frequently attributed to discomfort, fatigue, or symptom aggravation during exercises that challenge impaired sensorimotor systems. These observations suggest that uniform rehabilitation protocols may not optimally address individualized neuromuscular profiles and that subgroup-specific interventions may enhance treatment responsiveness, improve adherence, and reduce variability in outcomes.
Cervical movement control involves coordinated interaction between proprioceptive, vestibular, and visual systems. Movement tasks performed at varying amplitudes and velocities challenge different components of sensorimotor processing and may reveal distinct deficit patterns. Slow, large-amplitude movements increase reliance on proprioceptive discrimination and smoothness regulation, often reflected in elevated jerk index values when coordination is impaired. Faster movements may engage vestibular-dependent mechanisms and dynamic stability control. Furthermore, altered afferent input from cervical muscles can influence adaptive plastic changes in vestibular-dependent motion sensitivity, potentially affecting head and neck control at higher movement velocities. Consequently, assessment and training should incorporate movements across multiple amplitudes and velocities to adequately capture subgroup-specific impairments.
Head and neck movement control tests frequently require participants to track visually presented targets while performing controlled movements, thereby demanding coordinated eye and head interaction. The importance of the visual system in neck pain is supported by neurophysiological connections between upper cervical afferent pathways and visual and vestibular nuclei at the brainstem level. Patients with neck pain frequently present with oculomotor disturbances, particularly during neck torsion maneuvers, likely arising from altered cervico-ocular and cervico-collic reflex contributions. Previous work has suggested associations between cervical kinaesthetic deficits and eye movement control, yet it remains unclear to what extent targeted kinaesthetic training can modify these oculomotor adaptations and whether such changes parallel improvements in pain and functional status.
Traditional analytical strategies commonly evaluate individual kinematic parameters independently, potentially overlooking complex interactions among movement precision, amplitude regulation, and smoothness. High-dimensional datasets generated from movement control testing contain non-linear relationships that may not be adequately captured using conventional univariate statistical methods. Data mining and machine learning approaches enable identification of latent structure within multidimensional datasets and facilitate clustering of patients according to shared functional characteristics. Prior analyses conducted on a cohort of 135 individuals with idiopathic neck pain identified four distinct clusters based on combinations of movement control variables, pain intensity, and demographic characteristics. These clusters demonstrated unique kinematic profiles, supporting the existence of clinically meaningful heterogeneity within this population and suggesting that targeted therapeutic strategies may be warranted.
The present study applies a classification-based rehabilitation framework derived from these previous clustering findings. Cervical kinaesthetic function will be comprehensively assessed using movement control testing and head-to-neutral relocation testing, supplemented by demographic and clinical variables including pain intensity. Participants will be assigned to previously defined clusters using established classification algorithms that integrate multidimensional movement and demographic data. Following classification, participants will receive either cluster-specific kinematic training designed to target the predominant impairments characteristic of their subgroup or a general kinematic training program not tailored to cluster membership. The structure, frequency, and duration of training exposure will be comparable between groups to ensure that differences in outcome are attributable to content rather than dose. Three-month follow-up measurements will be conducted to evaluate the persistence of intervention effects and to explore whether individualized rehabilitation influences medium-term symptom stability.
Movement control assessment will involve visually guided head tracking tasks performed with inertial measurement units capturing high-resolution angular displacement data in real time. Participants will complete repeated trials across four progressively challenging movement paths characterized by increasing target amplitude and velocity to systematically stress different components of the sensorimotor system. Derived parameters will include precision time, representing percentage of trial time within the target zone; underreaching and overreaching, representing directional amplitude control errors; jerk index, reflecting smoothness of movement derived from the third derivative of position data; and amplitude accuracy, calculated as the average angular mismatch between target and performed movement. Position sense will be evaluated through blindfolded relocation to a self-selected neutral head position, with absolute error computed across repetitions and movement directions to quantify repositioning accuracy. Oculomotor control will be assessed using smooth pursuit testing in neutral and torsion positions, with eye movement recordings filtered for artifacts, synchronized with reference trajectories, and analyzed to compute pursuit gain as the ratio of eye velocity amplitude to target velocity amplitude. Cervical range of motion will be quantified in all primary movement planes to characterize mobility profiles and potential mobility-related subgroup distinctions.
Data processing will involve systematic filtering of motion and eye movement signals, removal of blinks and saccades where appropriate, synchronization of reference trajectories, normalization of movement cycles, and averaging across repetitions to ensure stable parameter estimation. Statistical analyses will be performed using repeated-measures analysis of variance to evaluate time-by-group interactions across baseline, post-intervention, and follow-up assessments. Normality assumptions will be examined using distributional metrics, and data transformations will be applied when required to satisfy model assumptions. Machine learning procedures for cluster assignment will be conducted using dedicated data mining software, while inferential statistical analyses will be executed using established statistical packages. Effect sizes will be interpreted alongside statistical significance to contextualize clinical relevance.
By integrating multidimensional kinematic profiling with subgroup-specific rehabilitation strategies, this study seeks to determine whether classification-based training improves clinical outcomes, enhances neuromuscular adaptation, and reduces variability in treatment response compared with conventional non-individualized kinematic rehabilitation. In addition, the study aims to clarify mechanistic relationships between improvements in cervical sensorimotor control and changes in pain intensity, disability, dizziness, visual symptoms, and oculomotor function. The findings are expected to contribute to development of personalized, mechanism-based rehabilitation models aimed at reducing recurrence, limiting chronicity, and improving long-term functional outcomes in individuals with idiopathic neck pain.
- Conditions
- Chronic Neck Pain
- Being tested
- Smallest movement deficit training protocol, Smaller movement deficit training protocol, Larger movement deficit training group, Largest movement deficit training protocol, Control group intervention protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smallest movement deficit training protocolOther
Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with changing velocities (ranges of difficulty levels from 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM), and changes of direction/movements (combination of single and mixed axis of movement - flexion/extension and lef or right rotations). The listed parameters are increased when the average accuracy of two following training sessions reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.
Smaller movement deficit training protocolOther
Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with the task to catch the moving target (always starting 2-15 deg in front of the starting position of the head) moving at different constant velocities (ranges of individual trial velocities at different difficulty levels - 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM). Movements will be perfromed in a diagonal 2D line encompasing flexion/extension and rotations). The listed parameters are increased when the average session accuracy reaches 60% time-on-target. If 60% time-on-target will be reached before the end of 4 week training period, general training intervention will be continued. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.
Larger movement deficit training groupOther
Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with the task to follow the moving target (always starting at the same starting position of the head) moving at different constant velocities (ranges of individual trial velocities at different difficulty levels - 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM). All movements finish at random point which has to be maintained for 5 s. Movements will be performed in diagonal 2D lines simultaneously encompasing flexion/extension and rotations). The listed parameters are increased when the average session accuracy reaches 60% time-on-target. If 60% time-on-target will be reached before the end of 4 week training period, training intervention of the group with smaller movement deficits will be continued. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.
Largest movement deficit training protocolOther
Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with the goal to follow the moving target (always starting at the same starting position as the head) moving at different constant velocities (ranges of individual trial velocities at different difficulty levels - 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM). All movements finish at random point which has to be maintained for 5 s. Movements will be performed in a single axis (flexion/extension and seperatelly rotations). The listed parameters are increased when the average session accuracy reaches 60% time-on-target. If 60% time-on-target will be reached before the end of 4 week training period, training intervention of the group with larger movement deficits will be continued. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.
Control group intervention protocolOther
Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with constant velocities (ranges of difficulty levels from 0,5 to 3, 3 to 5, and 4 to 7 deg/s), at different amplitudes between trials (40 to 90% ROM), and at predefined movement paths (square, circle, zig-zag and figure of 8 pattern). The listed parameters are increased when the average accuracy of two following training sessions reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patietns with smallest movement deficits | Experimental | A group that in kinematic movement assessment presents with most time and closest to the target, with lowest overeaching and low unereaching. This group presents with mild to moderate pain levels.
Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with changing velocities, amplitudes and changes of direction without specific range of motion limits. The listed parameters are increased when the average session accuracy reaches 60% time-on-target.
Patients will perform 4 training sessions per week (20 min duration each), for four weeks. Receives: Other: Smallest movement deficit training protocol |
| Patients with smaller movement deficits | Experimental | This group stays considerable amount of time and close to the target, has high underreaching at medium and difficult level and smallest overreaching at all difficulty levels; presents with mild to moderate pain levels.
Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with randomly changing velocities, in a predefined movement directions. The listed parameters are increased when the average session accuracy reaches 60% time-on-target. When 60% time-on-target is reached at the difficult level, random moveemnt directions are introduced. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. Receives: Other: Smaller movement deficit training protocol |
| Patients with lerger movement deficits | Experimental | This gorup stays less time and further away from the target, with high underreaching, most prominent feature is high overreaching; presents with mild to moderate pain levels.
Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with constant velocities, amplitudes with no changes of direction and with range of motion limits relative to the pain onset. The listed parameters are increased when the average session accuracy reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. Receives: Other: Larger movement deficit training group |
| Patients with largest movement deficits | Experimental | This gorup stays least time and furthest away from the target, with highest undershoot (all difficulty levels, with significantly affected performance already at easy level) and overshoot; presents with moderate to severe pain levels Receives: Other: Largest movement deficit training protocol |
| Control group of patinets with neck pain | Active comparator | Group of patients with neck pain consisting equally from all four cluster groups. Receives: Other: Control group intervention protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vas score (Visual analogue scale - pain intensity level)
The Visual Analogue Scale (VAS) is a patient-reported measure of pain intensity. Participants rate their current neck pain on a 10-cm horizontal line anchored by:
- 0 = no pain (best outcome)
- 10 = worst imaginable pain (worst outcome)
The score is determined by measuring the distance (in centimeters or millimeters) from the "no pain" anchor to the participant's mark. Total scores therefore range from 0 to 10 (or 0-100 mm), with higher scores indicating greater pain intensity.
A decrease in VAS score over time indicates improvement, while an increase indicates worsening pain. For responder analyses, a clinically meaningful improvement is defined as a reduction of at least 2 points (or 20 mm) from baseline.
Measured: Start of the study, after 4 week training period and after 3 months follow up period
NDI score
The Neck Disability Index is a patient-reported questionnaire assessing how neck pain affects daily activities. It includes 10 items (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation). Each item is scored from 0 to 5, where:
- 0 indicates no pain or no functional limitation (best outcome)
- 5 indicates maximum pain or complete functional limitation (worst outcome)
The total score ranges from 0 to 50, with:
- 0 = no neck-related disability (best possible score)
- 50 = maximum disability (worst possible score)
For reporting purposes, the total score may also be expressed as a percentage from 0% (no disability) to 100% (complete disability).
A decrease in score over time indicates improvement, while an increase indicates worsening disability.
For analyses using a responder threshold, participants are considered to have achieved a clinically meaningful improvement if their total NDI score decreases by at least 5 points (on
Measured: Start of the study, after 4 week training period and after 3 months follow up period
Secondary outcomes (6)
Precision time (in movement control test)
Precision Time is an objective outcome derived from the cervical movement control tests, a computerized cervical movement control task. Participants control a visual cursor using head or neck movements and are instructed to keep the cursor aligned with a moving or stationary on-screen target.
Precision Time is expressed as the percentage of total trial time during which the cursor remains within a predefined target zone. Scores range from 0% (cursor never within the target; worst performance) to 100% (cursor within the target for the entire trial; best performance).
Higher Precision Time values indicate better cervical sensorimotor control and movement accuracy. An increase in Precision Time across assessments reflects improvement.
Measured: At start, after 4 week intervention and at 3 month follow-up period.
Underreaching (in movement control test)
Underreaching (undershoot) is an objective performance metric derived from a computerized cervical movement control test. During the test, participants use head or neck movements to guide a visual cursor toward a target displayed on a screen.
Underreaching represents the percentage of total trial time during which the cursor remains short of the target zone (i.e., does not reach the required amplitude or position). Scores range from 0% (no undershoot; best performance) to 100% (cursor consistently fails to reach the target; worst performance).
Higher underreaching values indicate reduced movement amplitude control and impaired cervical sensorimotor accuracy. A decrease in underreaching across repeated assessments reflects improvement.
Measured: At start, after 4 week intervention and at 3 month follow-up period.
Overreaching (movement control test)
Overshoot (overreaching) is an objective performance metric derived from a computerized cervical movement control test. During the test, participants use head or neck movements to guide a visual cursor toward a target displayed on a screen.
Overshoot represents the percentage of total trial time during which the cursor exceeds the predefined target zone (i.e., moves beyond the required amplitude or position). Scores range from 0% (no overshoot; best performance) to 100% (cursor consistently exceeds the target zone; worst performance).
Higher overshoot values indicate reduced movement precision and impaired control of movement amplitude. A decrease in overshoot across repeated assessments reflects improvement.
Measured: At start, after 4 week intervention and at 3 month follow-up period.
Jerk index (in movement control test)
Jerk Index is an objective kinematic performance metric derived from a computerized cervical movement control test. During the test, participants use head or neck movements to guide a visual cursor toward a target displayed on a screen.
The Jerk Index quantifies movement smoothness by calculating the rate of change of acceleration (jerk) across the movement trajectory, normalized to trial duration and amplitude. Higher values reflect less smooth, more abrupt or irregular movements, whereas lower values indicate smoother and more controlled motion.
Scores range from 0 (perfectly smooth movement; best performance) upward, with no fixed upper limit; higher scores represent poorer movement control (worse performance). A decrease in Jerk Index across repeated assessments indicates improvement in cervical motor control.
Measured: At start, after 4 week intervention and at 3 month follow-up period.
Absolute error (in head-to-neutral relocation test)
Absolute Error is an objective performance metric derived from a computerized cervical movement control test. During the test, participants use head or neck movements to guide a visual cursor to a target displayed on a screen.
Absolute Error quantifies amplitude accuracy as the absolute difference between the required target position/amplitude and the participant's achieved cursor position/amplitude (averaged across the trial, repetition, or task segment as defined by the software).
Scores range from 0 (no error; best performance) upward, with no fixed upper limit. Lower Absolute Error indicates better accuracy, while higher values indicate poorer amplitude accuracy (worse performance). A decrease in Absolute Error across assessments reflects improvement.
Measured: At start, after 4 week intervention and at 3 month follow-up period.
Gain (smooth pursuit eye movement test)
Gain is an objective oculomotor performance metric derived from a smooth pursuit eye movement test. During the test, the participant's head is stabilized in a predefined neutral position, and the participant follows a continuously moving on-screen target using focal vision only.
Gain is calculated as the ratio of eye movement velocity to target velocity (eye velocity ÷ target velocity), typically averaged across the tracking interval. A value of 1.0 indicates perfect pursuit accuracy (eye velocity matches target velocity).
Values >1.0 indicate excessive eye velocity. The optimal value is 1.0 (best performance). Negative deviations from 1.0 reflect impaired smooth pursuit control, consistent with reports of altered oculomotor function in individuals with neck pain. Improvement is defined as gain values moving closer to 1.0 across assessments.
Measured: At start, after 4 week intervention and at 3 month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start18 Mar 2026 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziva Majcen Rosker, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418632
- Sponsor's protocol ID
- 0120-48/2023/8
- Status last verified
- Feb 2026
- First submitted
- 10 Aug 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of the study demand analysis of patient groups not individual data. Therefore IPD will be analyzed and shared in any way.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Ability of Datamining Approaches to Cluster Patients With Idiopathic Neck Pain and Can Machine Learning Algorithms Provide More Efficient Rehabilitation and Less Recurrence Based on Kinaesthetic Training Protocols
- ClinicalTrials.gov ID
- NCT07418632
- Acronym / sponsor ID
- 0120-48/2023/8
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 18 Feb 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.
The goal of this clinical trial is to study if kinematic training based on novel kinematic assessment clasification approach can decrease chronic neck pain and prevent its reoccurance better than conventional kinematic training in adults. The main question[s] it aims to answer [is/are]:
Does clustering patients with neck pain based on head and neck movement characteristics lead to more efficient kinematic rehabilitation training and improved clinical outcomes
Researchers will compare effects of cluster specific kinematic training to see if it effects pain levels and its reoccurance.
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Detailed description
Chronic idiopathic neck pain represents one of the most prevalent musculoskeletal conditions worldwide and is characterized by recurrent episodes, fluctuating symptom intensity, and frequent transition to persistent disability. While clinical management commonly focuses on short-term pain reduction, the more substantial societal burden arises from recurrence and chronicity rather than isolated acute episodes. Recurrent neck pain contributes to repeated healthcare consultations, prolonged work absenteeism, reduced productivity, and increasing healthcare expenditure. Despite the widespread use of exercise-based rehabilitation, recurrence rates remain high, suggesting that prevailing treatment approaches may insufficiently address the mechanisms underlying persistent dysfunction. As the prevalence of neck pain continues to rise across working-age populations, it is reasonable to question whether current rehabilitation models adequately target the neuromuscular and sensorimotor contributors to chronicity and repeated symptom exacerbations.
Most individuals presenting for physical therapy are diagnosed with non-specific or idiopathic neck pain, a broad category encompassing heterogeneous clinical presentations with variable combinations of pain, stiffness, dizziness, visual disturbances, and impaired movement control. Patients may differ substantially in movement strategies, proprioceptive acuity, neuromuscular coordination, and adaptive motor patterns, yet they are frequently managed using standardized exercise protocols. Conventional clinical assessment tools are effective in distinguishing patients from asymptomatic individuals but provide limited resolution for identifying meaningful subgroups within the idiopathic neck pain population. Over the last decade, patient-centered evaluation in spinal disorders has frequently relied on numerical pain rating scales and disability questionnaires, while comparatively less emphasis has been placed on objective assessment of neuromuscular control mechanisms that may drive chronicity. Emerging evidence demonstrates that individuals with a history of neck pain exhibit persistent alterations in sensorimotor function even during symptom remission, implying that underlying neuromuscular adaptations may predispose individuals to recurrence and reduced resilience to mechanical or psychosocial stressors.
Cervical sensorimotor control, often conceptualized as cervicocephalic kinaesthetic awareness, integrates proprioceptive input from cervical musculature and joint mechanoreceptors with visual and vestibular information to coordinate accurate head positioning and smooth eye-head movements. Altered cervical afferent input can disrupt this integration, leading to inaccurate movement perception, impaired position sense, and maladaptive motor output strategies. Prolonged proprioceptive disturbances may induce central neural plasticity changes within brainstem and cortical sensorimotor networks, potentially sustaining dysfunction beyond the initial pain episode and contributing to the maintenance of chronic symptoms. Systematic reviews report variable findings regarding the magnitude of kinaesthetic impairments in neck pain populations, likely reflecting recruitment heterogeneity, differences in symptom duration, and variability in functional deficits. These inconsistencies underscore the importance of multidimensional characterization of sensorimotor performance rather than reliance on isolated parameters or single test outcomes.
Kinaesthetic training targeting movement accuracy, proprioceptive recalibration, and coordinated motor output has demonstrated clinically meaningful short-term improvements in pain and disability, with some effects persisting for several months. However, approximately one third of patients fail to demonstrate improvement in pain intensity or disability, and nearly half do not exhibit measurable gains in objective kinematic performance variables. Additionally, dropout rates of up to twenty percent have been reported, frequently attributed to discomfort, fatigue, or symptom aggravation during exercises that challenge impaired sensorimotor systems. These observations suggest that uniform rehabilitation protocols may not optimally address individualized neuromuscular profiles and that subgroup-specific interventions may enhance treatment responsiveness, improve adherence, and reduce variability in outcomes.
Cervical movement control involves coordinated interaction between proprioceptive, vestibular, and visual systems. Movement tasks performed at varying amplitudes and velocities challenge different components of sensorimotor processing and may reveal distinct deficit patterns. Slow, large-amplitude movements increase reliance on proprioceptive discrimination and smoothness regulation, often reflected in elevated jerk index values when coordination is impaired. Faster movements may engage vestibular-dependent mechanisms and dynamic stability control. Furthermore, altered afferent input from cervical muscles can influence adaptive plastic changes in vestibular-dependent motion sensitivity, potentially affecting head and neck control at higher movement velocities. Consequently, assessment and training should incorporate movements across multiple amplitudes and velocities to adequately capture subgroup-specific impairments.
Head and neck movement control tests frequently require participants to track visually presented targets while performing controlled movements, thereby demanding coordinated eye and head interaction. The importance of the visual system in neck pain is supported by neurophysiological connections between upper cervical afferent pathways and visual and vestibular nuclei at the brainstem level. Patients with neck pain frequently present with oculomotor disturbances, particularly during neck torsion maneuvers, likely arising from altered cervico-ocular and cervico-collic reflex contributions. Previous work has suggested associations between cervical kinaesthetic deficits and eye movement control, yet it remains unclear to what extent targeted kinaesthetic training can modify these oculomotor adaptations and whether such changes parallel improvements in pain and functional status.
Traditional analytical strategies commonly evaluate individual kinematic parameters independently, potentially overlooking complex interactions among movement precision, amplitude regulation, and smoothness. High-dimensional datasets generated from movement control testing contain non-linear relationships that may not be adequately captured using conventional univariate statistical methods. Data mining and machine learning approaches enable identification of latent structure within multidimensional datasets and facilitate clustering of patients according to shared functional characteristics. Prior analyses conducted on a cohort of 135 individuals with idiopathic neck pain identified four distinct clusters based on combinations of movement control variables, pain intensity, and demographic characteristics. These clusters demonstrated unique kinematic profiles, supporting the existence of clinically meaningful heterogeneity within this population and suggesting that targeted therapeutic strategies may be warranted.
The present study applies a classification-based rehabilitation framework derived from these previous clustering findings. Cervical kinaesthetic function will be comprehensively assessed using movement control testing and head-to-neutral relocation testing, supplemented by demographic and clinical variables including pain intensity. Participants will be assigned to previously defined clusters using established classification algorithms that integrate multidimensional movement and demographic data. Following classification, participants will receive either cluster-specific kinematic training designed to target the predominant impairments characteristic of their subgroup or a general kinematic training program not tailored to cluster membership. The structure, frequency, and duration of training exposure will be comparable between groups to ensure that differences in outcome are attributable to content rather than dose. Three-month follow-up measurements will be conducted to evaluate the persistence of intervention effects and to explore whether individualized rehabilitation influences medium-term symptom stability.
Movement control assessment will involve visually guided head tracking tasks performed with inertial measurement units capturing high-resolution angular displacement data in real time. Participants will complete repeated trials across four progressively challenging movement paths characterized by increasing target amplitude and velocity to systematically stress different components of the sensorimotor system. Derived parameters will include precision time, representing percentage of trial time within the target zone; underreaching and overreaching, representing directional amplitude control errors; jerk index, reflecting smoothness of movement derived from the third derivative of position data; and amplitude accuracy, calculated as the average angular mismatch between target and performed movement. Position sense will be evaluated through blindfolded relocation to a self-selected neutral head position, with absolute error computed across repetitions and movement directions to quantify repositioning accuracy. Oculomotor control will be assessed using smooth pursuit testing in neutral and torsion positions, with eye movement recordings filtered for artifacts, synchronized with reference trajectories, and analyzed to compute pursuit gain as the ratio of eye velocity amplitude to target velocity amplitude. Cervical range of motion will be quantified in all primary movement planes to characterize mobility profiles and potential mobility-related subgroup distinctions.
Data processing will involve systematic filtering of motion and eye movement signals, removal of blinks and saccades where appropriate, synchronization of reference trajectories, normalization of movement cycles, and averaging across repetitions to ensure stable parameter estimation. Statistical analyses will be performed using repeated-measures analysis of variance to evaluate time-by-group interactions across baseline, post-intervention, and follow-up assessments. Normality assumptions will be examined using distributional metrics, and data transformations will be applied when required to satisfy model assumptions. Machine learning procedures for cluster assignment will be conducted using dedicated data mining software, while inferential statistical analyses will be executed using established statistical packages. Effect sizes will be interpreted alongside statistical significance to contextualize clinical relevance.
By integrating multidimensional kinematic profiling with subgroup-specific rehabilitation strategies, this study seeks to determine whether classification-based training improves clinical outcomes, enhances neuromuscular adaptation, and reduces variability in treatment response compared with conventional non-individualized kinematic rehabilitation. In addition, the study aims to clarify mechanistic relationships between improvements in cervical sensorimotor control and changes in pain intensity, disability, dizziness, visual symptoms, and oculomotor function. The findings are expected to contribute to development of personalized, mechanism-based rehabilitation models aimed at reducing recurrence, limiting chronicity, and improving long-term functional outcomes in individuals with idiopathic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patietns with smallest movement deficits | Experimental | Other: Smallest movement deficit training protocolA group that in kinematic movement assessment presents with most time and closest to the target, with lowest overeaching and low unereaching. This group presents with mild to moderate pain levels. Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with changing velocities, amplitudes and changes of direction without specific range of motion limits. The listed parameters are increased when the average session accuracy reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. |
| Patients with smaller movement deficits | Experimental | Other: Smaller movement deficit training protocolThis group stays considerable amount of time and close to the target, has high underreaching at medium and difficult level and smallest overreaching at all difficulty levels; presents with mild to moderate pain levels. Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with randomly changing velocities, in a predefined movement directions. The listed parameters are increased when the average session accuracy reaches 60% time-on-target. When 60% time-on-target is reached at the difficult level, random moveemnt directions are introduced. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. |
| Patients with lerger movement deficits | Experimental | Other: Larger movement deficit training groupThis gorup stays less time and further away from the target, with high underreaching, most prominent feature is high overreaching; presents with mild to moderate pain levels. Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with constant velocities, amplitudes with no changes of direction and with range of motion limits relative to the pain onset. The listed parameters are increased when the average session accuracy reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. |
| Patients with largest movement deficits | Experimental | Other: Largest movement deficit training protocolThis gorup stays least time and furthest away from the target, with highest undershoot (all difficulty levels, with significantly affected performance already at easy level) and overshoot; presents with moderate to severe pain levels |
| Control group of patinets with neck pain | Active comparator | Other: Control group intervention protocolGroup of patients with neck pain consisting equally from all four cluster groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presence of neck pain
- pain level minimum 3 of 10 on VAS
- did not receive conventional physiotherapy in last 6 months
Key exclusion criteria (5 listed)
- any upper extremity pain within last 2 years
- any neurological or vestibular dissorders
- type 2 diabetes
- diagnosed psychiatric dissorders
- medication or alcohol consumptin in last 30 hours
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 |
|---|---|---|
| Smallest movement deficit training protocolKinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with changing velocities (ranges of difficulty levels from 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM), and changes of direction/movements (combination of single and mixed axis of movement - flexion/extension and lef or right rotations). The listed parameters are increased when the average accuracy of two following training sessions reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. | Other | Patietns with smallest movement deficits |
| Smaller movement deficit training protocolKinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with the task to catch the moving target (always starting 2-15 deg in front of the starting position of the head) moving at different constant velocities (ranges of individual trial velocities at different difficulty levels - 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM). Movements will be perfromed in a diagonal 2D line encompasing flexion/extension and rotations). The listed parameters are increased when the average session accuracy reaches 60% time-on-target. If 60% time-on-target will be reached before the end of 4 week training period, general training intervention will be continued. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. | Other | Patients with smaller movement deficits |
| Larger movement deficit training groupKinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with the task to follow the moving target (always starting at the same starting position of the head) moving at different constant velocities (ranges of individual trial velocities at different difficulty levels - 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM). All movements finish at random point which has to be maintained for 5 s. Movements will be performed in diagonal 2D lines simultaneously encompasing flexion/extension and rotations). The listed parameters are increased when the average session accuracy reaches 60% time-on-target. If 60% time-on-target will be reached before the end of 4 week training period, training intervention of the group with smaller movement deficits will be continued. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. | Other | Patients with lerger movement deficits |
| Largest movement deficit training protocolKinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with the goal to follow the moving target (always starting at the same starting position as the head) moving at different constant velocities (ranges of individual trial velocities at different difficulty levels - 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM). All movements finish at random point which has to be maintained for 5 s. Movements will be performed in a single axis (flexion/extension and seperatelly rotations). The listed parameters are increased when the average session accuracy reaches 60% time-on-target. If 60% time-on-target will be reached before the end of 4 week training period, training intervention of the group with larger movement deficits will be continued. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. | Other | Patients with largest movement deficits |
| Control group intervention protocolKinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with constant velocities (ranges of difficulty levels from 0,5 to 3, 3 to 5, and 4 to 7 deg/s), at different amplitudes between trials (40 to 90% ROM), and at predefined movement paths (square, circle, zig-zag and figure of 8 pattern). The listed parameters are increased when the average accuracy of two following training sessions reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks. | Other | Control group of patinets with neck pain |
Primary outcome
Vas score (Visual analogue scale - pain intensity level)
Time frame: Start of the study, after 4 week training period and after 3 months follow up period
The Visual Analogue Scale (VAS) is a patient-reported measure of pain intensity. Participants rate their current neck pain on a 10-cm horizontal line anchored by: * 0 = no pain (best outcome) * 10 = worst imaginable pain (worst outcome) The score is determined by measuring the distance (in centimeters or millimeters) from the "no pain" anchor to the participant's mark. Total scores therefore range from 0 to 10 (or 0-100 mm), with higher scores indicating greater pain intensity. A decrease in VAS score over time indicates improvement, while an increase indicates worsening pain. For responder analyses, a clinically meaningful improvement is defined as a reduction of at least 2 points (or 20 mm) from baseline.
NDI score
Time frame: Start of the study, after 4 week training period and after 3 months follow up period
The Neck Disability Index is a patient-reported questionnaire assessing how neck pain affects daily activities. It includes 10 items (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation). Each item is scored from 0 to 5, where: * 0 indicates no pain or no functional limitation (best outcome) * 5 indicates maximum pain or complete functional limitation (worst outcome) The total score ranges from 0 to 50, with: * 0 = no neck-related disability (best possible score) * 50 = maximum disability (worst possible score) For reporting purposes, the total score may also be expressed as a percentage from 0% (no disability) to 100% (complete disability). A decrease in score over time indicates improvement, while an increase indicates worsening disability. For analyses using a responder threshold, participants are considered to have achieved a clinically meaningful improvement if their total NDI score decreases by at least 5 points (on
6 secondary outcomes
Precision time (in movement control test)
Time frame: At start, after 4 week intervention and at 3 month follow-up period.
Underreaching (in movement control test)
Time frame: At start, after 4 week intervention and at 3 month follow-up period.
Overreaching (movement control test)
Time frame: At start, after 4 week intervention and at 3 month follow-up period.
Jerk index (in movement control test)
Time frame: At start, after 4 week intervention and at 3 month follow-up period.
Absolute error (in head-to-neutral relocation test)
Time frame: At start, after 4 week intervention and at 3 month follow-up period.
Gain (smooth pursuit eye movement test)
Time frame: At start, after 4 week intervention and at 3 month follow-up period.
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 18 Feb 2026.
- Individual participant dataSharing planned: No. The results of the study demand analysis of patient groups not individual data. Therefore IPD will be analyzed and shared in any way.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smallest movement deficit training protocol, Smaller movement deficit training protocol and Larger movement deficit training group in people with Chronic Neck Pain, run by University of Ljubljana at 1 site in Slovenia.
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 3 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: looking for participants now, as of the sponsor's last update on 18 Feb 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 Slovenia. 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 Ziva Majcen rosker, PhD, PT (00386 51267383, ziva.majcen-rosker@fsp.uni-lj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vas score (Visual analogue scale - pain intensity level) (time frame: Start of the study, after 4 week training period and after 3 months follow up period). 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?
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 18 Feb 2026.