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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Vas score (Visual analogue scale - pain intensity level)
研究概览
简要总结
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].
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of neck pain
- •pain level minimum 3 of 10 on VAS
- •did not receive conventional physiotherapy in last 6 months
排除标准
- •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
研究组 & 干预措施
Patietns with smallest movement deficits
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.
干预措施: Smallest movement deficit training protocol (Other)
Patients with smaller movement deficits
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.
干预措施: Smaller movement deficit training protocol (Other)
Patients with lerger movement deficits
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.
干预措施: Larger movement deficit training group (Other)
Patients with largest movement deficits
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
干预措施: Largest movement deficit training protocol (Other)
Control group of patinets with neck pain
Group of patients with neck pain consisting equally from all four cluster groups.
干预措施: Control group intervention protocol (Other)
结局指标
主要结局
Vas score (Visual analogue scale - pain intensity level)
时间窗: 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
时间窗: 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
次要结局
- Absolute error (in head-to-neutral relocation test)(At start, after 4 week intervention and at 3 month follow-up period.)
- Precision time (in movement control test)(At start, after 4 week intervention and at 3 month follow-up period.)
- Underreaching (in movement control test)(At start, after 4 week intervention and at 3 month follow-up period.)
- Overreaching (movement control test)(At start, after 4 week intervention and at 3 month follow-up period.)
- Jerk index (in movement control test)(At start, after 4 week intervention and at 3 month follow-up period.)
- Gain (smooth pursuit eye movement test)(At start, after 4 week intervention and at 3 month follow-up period.)
研究者
Ziva Majcen Rosker
assist. prof. Ziva Majcen Rosker, PT, PhD
University of Ljubljana
