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临床试验/NCT04242576
NCT04242576已完成不适用

Evaluation of Nociceptive Processing in the Cervical Region Through Action Observation, Laterality Discrimination and Exercise

Josue Fernandez Carnero2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
Changes in cervical range of movement.

研究概览

简要总结

The main objective of this research is to asses the effectivity of action observation therapy, left/right discrimination and therapeutic exercise in the nociceptive processing of the cervical region.

详细描述

Neck pain is the fourth cause of loss of years due to disability, behind back pain, depression and joint pain. Studies show that about half of the population will experience at least one episode of the clinically important neck during their life. The vast majority of studies indicate a prevalence of neck pain that varies between 15% and 50%, including a systematic review with a ratio of 37.2%, the investigators can ensure that neck pain is a common pathology among the population. Among the variables associated with neck pain, besides rheumatology, include genetic, psychopathological variables (such as depression, anxiety, coping skills, somatization), sleep disorders, smoking and a sedentary lifestyle, among others. All those variables alter the nervous system in a proprioceptive level, so that deep and superficial flexor, as well as the rest of the muscles, they do not receive correct information that prevents them from processing properly the obtained information. Therefore, alterations also occur at central nervous system levels as in the processing of pain and its control by inhibitory descending systems.

The most used treatment for neck pain is exercise. In a recent Cochrane review conducted by Gross A. et al., It has been proven, despite the shortage of high-quality studies, that the use of exercise routines based on strength and resistance training causes a reduction in pain.

Motor imagery (MI) or graduated motor imagery (GMI) is defined as "the mental and dynamic process of action, without real movement execution" and the action observation (AO) consists in observing an action carried out by another person. These treatments are based on the ability of the nervous system to assimilate the images seen and process them until they reach the motor cortex, and thanks to the mirror neurons, the painful pattern decreases until it disappears. Thus, visualising a painful situation provokes and evokes in the brain, a painful experience, even when this is not actually happening.

Therefore, the interruption of this neural network of cortical proprioceptive representations and integration of motor processes, also known as "body schema", is particularly relevant for movement and manual therapies. One way to measure the current state of the body scheme is through laterality tasks or "left / right judgement task" (LRJT), which have proven to be an effective and reliable tool and can also be used as a treatment.

All of the above facilitates the possibility of using these tools as treatments focused on the cortical area with GMI. However, the effectiveness of MI is controversial. Some studies have been carried out in pathological patients, in a pilot study they confirmed the changes produced in the neck region, both by an increase in the range of movement and an increase in the pain threshold to pressure, focused on the population with chronic neck pain. It is difficult to find studies in healthy patients, although in recent years some publications on motor imagery can be found finding changes in the descending inhibitory systems of pain and its processing. Many variables such as the duration of the sessions, the time per exercise or the type of tasks to be performed, together with the lack of studies on the neck region and the comparison between different tasks and their respective affectation of the descending pain inhibitory systems, have led us to carry out this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Single blind

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
是

入选标准

  • •Healthy volunteers.
  • •Asymptomatic on cervical region.
  • •Understands and accept the informed consent.
  • •Spanish speakers.
  • •People with no cognitive disorders.

排除标准

  • •Pregnant women.
  • •Positive neurological signs or evidence of spinal cord compression (abnormal diffuse sensitivity, hyperreflexia or diffuse weakness).
  • •Previous cervical surgeries with recurrent symptoms.
  • •Previous headaches.
  • •Inability to provide informed consent.
  • •Cognitive disorders.
  • •Reading or verbal misunderstanding when receiving instructions.
  • •Having suffered any pain in the last 3 months, both in the quadrant suppressor as in the lumbar region and pelvis.
  • •Suffer any pain at the time of the study.
  • •Any recent traumatic event, whether physical or psychological / emotional.

研究组 & 干预措施

Action Observation

Experimental

Subjects will watch 30-second videos, with a one-minute break between videos. The videos show the actions that subjects should imagine while watching the video.

干预措施: Action Observation (Other)

Right/Left Judgment Task

Experimental

The laterality will be trained with the Recognize® application. Once the subjects have been trained, they are instructed to solve the different sections of the application, starting with the simplest tasks until reaching the most difficult ones.

These tasks would consist of indicating "left" or "right", among the different images that appear on the iPad screen, indicating if the image's neck is rotated to the left or right. Being every level more complicated, so that people of different skin tones, with clothes or in a work environment are added.

干预措施: Right Left Judgement (Device)

Exercise

Active Comparator

The subjects perform the exercises provided by the researchers. Which consist of neck exercises in all ranges of movement (inclinations and rotations to both sides), apart from flexion and extension.

干预措施: Exercise (Behavioral)

结局指标

主要结局

Changes in cervical range of movement.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

Measured with goniometer by the physiotherapists.

Changes in upper Limb Neurodinamics.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

Upper limb neurodinamics test measuring with a goniometer on what grade of joint movement with nerve stretching pain appears.

Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

Pressure Pain Tresholds using an algometer on first finger, trapezius muscle and tibia.

Changes in pain perception.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).

Changes in deep neck flexors activation.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

Deep neck flexor endurance test.

Changes in endogenous pain inhibition mechanisms.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

Conditioned pain modulation and temporal summation (windup), using the algometer and an oclussion band.

Changes in pain to cold threshold.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

Cold stimulation test using cold compresses on the cervical region two times during 10 minutes.

Changes in the subject's selective attention capacity and skills as well as their processing speed ability.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

It will be measured using the Encephalapp application. The time taken to perform 2 successful trials of 10 images without making an error was recorded.

Changes in pain treshold perception.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

Mechanical nociceptive threshold test using Von-Frey filaments.

Changes in hand and forearm muscular strenght.

时间窗: Before and after the treatment (2 weeks), after 15 days and after 30 days.

Handgrip strenght test using a dynamometer.

次要结局

  • Changes in levels of Catastrophism.(Before and after the treatment (2 weeks), after 15 days and after 30 days.)
  • Changes in Fear-avoidance behaviours.(Before and after the treatment (2 weeks), after 15 days and after 30 days.)
  • Changes in patient's anxiety.(Before and after the treatment (2 weeks), after 15 days and after 30 days.)
  • Changes in level of Depression.(Before and after the treatment (2 weeks), after 15 days and after 30 days.)
  • Changes in the ability to generate mental motor images.(Before and after the treatment (2 weeks), after 15 days and after 30 days.)
  • Changes in Kinesiophobia, levels of fear to movement.(Before and after the treatment (2 weeks), after 15 days and after 30 days.)

研究者

发起方
Josue Fernandez Carnero
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Josue Fernandez Carnero

Professor

Universidad Rey Juan Carlos

研究点 (2)

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