Prediction of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Global rating of change scale
研究概览
简要总结
The goal of this clinical trial is to investigate about the characteristics that predict response to physiotherapy treatment in patients with nerve related neck arm pain. The main question to answer is whether there is a subgroup that responds better to physiotherapy treatment.
Participants will be assessed for clinical and neurophysiological characteristics prior to treatment. Afterwards they will receive 6 sessions of manual physiotherapy treatment along with home nerve gliding exercises once a week. Baseline measurements will be taken again after treatment to know if there have been any changes.
详细描述
During the first visit, socio-demographic data will be collected. Then, participants will be assessed using the quantitative sensory testing (QST) to evaluate the excitability of the nervous system. In addition, questionnaires and scales will be used to obtain information on the psychosocial factors involved, neuropathic pain characteristics and on the disability caused by their situation.
Finally, various clinical tests will be carried out to obtain information on neck movement and irritability at closure of the intervertebral foramen, mechanosensitivity of the upper limb with neurodynamic testing and alterations in sensitivity, strength and myotatic reflexes. Also they will be asked for permission to access to their imaging tests.
Once the pre-treatment data has been obtained, the manual physiotherapy and exercise treatment will begin, which aims to reduce the irritability of the nervous system.
Once the treatment is completed, the initial measurements will be repeated along with a global rating of change scale to classify patients as responders vs. non-responders.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with unilateral cervicobrachial pain
排除标准
- •Signs of severe disease, cervical myelopathy, tumour, rheumatic diseases or a neurological pathology of central origin.
- •Cervicobrachial pain of traumatic origin or as a result of whiplash.
- •Previous surgical intervention of the cervical spine.
结局指标
主要结局
Global rating of change scale
时间窗: Pre-intervention and post-intervention at week 6 - Between intervention sessions, weekly. - Mid term: at week 14
Is a self-administered questionnaire that aims to measure the degree of subjective improvement since the first intervention received. 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, the patient is the same.
次要结局
- Central Sensitization Inventory (CSI)(Pre-intervention and post-intervention at week 6)
- Clinical examination(Pre-intervention and post-intervention at week 6)
- Numeric Pain Rating Scale (NPRS)(Pre-intervention and post-intervention at week 6 - Mid term: at week 14)
- Neck Disability Index(Pre-intervention and post-intervention at week 6 - Mid term: at week 14)
- Tampa Scale of Kinesiophobia (TSK-11)(Pre-intervention and post-intervention at week 6)
- Patient Specific Functional Scale (PSFS)(Pre-intervention and post-intervention at week 6)
- Examination of increased mechanosensitivity of nervous tissue(Pre-intervention and post-intervention at week 6)
- Pain mapping(Pre-intervention and post-intervention at week 6)
- Detection and thermal pain thresholds(Pre-intervention and post-intervention at week 6)
- Vibration detection threshold(Pre-intervention and post-intervention at week 6)
- Pain Detect Questionnaire (PD-Q)(Pre-intervention and post-intervention at week 6)
- Scale for sleep quality(Pre-intervention and post-intervention at week 6)
- Patient Catastrophizing Scale(Pre-intervention and post-intervention at week 6)
- Hospital anxiety and depression scale(Pre-intervention and post-intervention at week 6)
- Sensitivity to touch(Pre-intervention and post-intervention at week 6)
- Myotomes examination(Pre-intervention and post-intervention at week 6)
- Spurling test(Pre-intervention and post-intervention at week 6)
- Distraction test(Pre-intervention and post-intervention at week 6)
- Extension + rotation test(Pre-intervention and post-intervention at week 6)
- Range of motion in rotation(Pre-intervention and post-intervention at week 6)
- Pressure pain threshold(Pre-intervention and post-intervention at week 6)
- Myotatic reflexes of the upper extremity(Pre-intervention and post-intervention at week 6)
- Magnetic resonance imaging and radiography(Pre-intervention)
- Conditioned pain modulation(Pre-intervention and post-intervention at week 6)
- Temporal summation of pain(Pre-intervention and post-intervention at week 6)
- Offset Analgesia(Pre-intervention and post-intervention at week 6)
研究者
Xabat Casado
Physiotherapist
University of Deusto