Predictors of Response After Physiotherapy Treatment in People With Chronic Non-specific Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Global Rating of Change (GROC) scale
研究概览
简要总结
The goal of this clinical trial is to investigate whether electroencephalographic features are associated with the multidimensional clinical characteristics of adults with chronic non-specific neck pain and whether clinical and brain function measures change following physiotherapy. Participants with chronic non-specific neck pain will receive six weekly treatment sessions consisting of a manual physiotherapy and neck-specific exercise programme, including a home exercise programme. Clinical, psychophysical, and 64-channel electroencephalographic assessments will be performed at baseline and approximately one week after completion of the intervention. Clinical outcomes will also be reassessed 12 weeks after the last treatment session. Electroencephalographic recordings will be obtained while participants are seated comfortably and instructed to remain relaxed. EEG-derived measures will be examined in relation to pain intensity, neck-related disability, psychological and cognitive-affective factors, sleep quality, and psychophysical pain responses. Healthy participants without chronic neck pain will undergo a comparable baseline assessment to provide reference data for the interpretation of brain function in the clinical group.
详细描述
This non-randomized interventional study aims to investigate clinical and electroencephalographic characteristics in individuals with chronic non-specific neck pain and to examine changes following a physiotherapy intervention. A healthy control group will also be assessed to provide reference data for comparison with participants with chronic non-specific neck pain.
Participants with chronic non-specific neck pain will undergo a baseline assessment including clinical questionnaires, pain mapping, quantitative sensory testing, and 64-channel electroencephalographic recordings.
Following the baseline assessment, participants with chronic non-specific neck pain will receive six weekly physiotherapy sessions. The intervention will include passive mobilizations of the cervical and thoracic spine, soft tissue mobilizations, and a neck-specific home exercise programme involving neck flexor and extensor training.
The clinical, psychophysical, and electroencephalographic assessments will be repeated approximately one week after completion of the intervention. Perceived recovery, pain intensity, and neck-related disability will also be evaluated approximately 12 weeks after the final treatment session.
The study will examine baseline differences between participants with chronic non-specific neck pain and healthy controls and changes in clinical and electroencephalographic outcomes following physiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic non-specific neck pain (>3 months duration)
- •Willing and able to sign informed consent for study participation
排除标准
- •Concomitant neurological or psychiatric disease apart from depression (especially severe mental disorder or psychopathology)
- •Regular (daily) intake of benzodiazepines
- •Signs of severe disease, cervical myelopathy, tumour, rheumatic diseases or a neurological pathology of central origin
- •Neck pain of traumatic origin or as a result of whiplash
- •Previous surgical intervention of the cervical spine
研究组 & 干预措施
Physiotherapy group
Participants with chronic non-specific neck pain will receive a 6-week physiotherapy intervention consisting of six individual treatment sessions, including manual therapy directed at the cervical and thoracic regions, together with a home exercise program. Clinical and brain activity assessments will be performed before the intervention and approximately one week after completion of the intervention.
干预措施: Manual physiotherapy and neck-specific exercise programme (Other)
结局指标
主要结局
Global Rating of Change (GROC) scale
时间窗: Post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)
It is a single-item patient-reported outcome that aims to quantify a patient's perceived improvement or deterioration over time. The questionnaire is scored with 7 positive items to assess the patient's subjective improvement progressively. It also presents 7 negative items to assess whether the patient has worsened. The 0 is defined as no improvement or worsening.
次要结局
- Numeric Pain Rating Scale (NPRS)(Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session))
- Neck Disability Index (NDI)(Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session))
研究者
Ander Cervantes Benítez
Lecturer, Department of Physiotherapy, Faculty of Health Sciences
University of Deusto