Evaluation of Nociceptive Processing in the Cervical Region
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|ClinicalTrials.gov Identifier: NCT04242576|
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain, Neck||Device: Right Left Judgement Other: Action Observation Behavioral: Exercise||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Sequential Assignment|
|Masking Description:||Single blind|
|Official Title:||Evaluation of Nociceptive Processing in the Cervical Region Through Action Observation, Laterality Discrimination and Exercise|
|Actual Study Start Date :||December 20, 2018|
|Actual Primary Completion Date :||July 30, 2019|
|Actual Study Completion Date :||December 30, 2019|
Experimental: Action Observation
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.
Other: Action Observation
Videos of cervical movements.
Experimental: Right/Left Judgment Task
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.
Device: Right Left Judgement
It is an application by Noigroup (Neuro Orthopedic Institute), adapted to different devices.
Other Name: Recognise® by Noigroup
Active Comparator: Exercise
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.
Evidence based exercises for the neck.
- Changes in cervical range of movement. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]Measured with goniometer by the physiotherapists.
- Changes in pain perception. [ Time Frame: 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 the subject's selective attention capacity and skills as well as their processing speed ability. [ Time Frame: 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. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]Mechanical nociceptive threshold test using Von-Frey filaments.
- Changes in upper Limb Neurodinamics. [ Time Frame: 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. [ Time Frame: 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 endogenous pain inhibition mechanisms. [ Time Frame: 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. [ Time Frame: 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 deep neck flexors activation. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]Deep neck flexor endurance test.
- Changes in hand and forearm muscular strenght. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]Handgrip strenght test using a dynamometer.
- Changes in levels of Catastrophism. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]13 item Pain Catastrophic Scale that must be answered with a numeric value between 0 (not at all) and 4 (all the time), with a maximum score of 52 points, with higher scores indicating greater pain catastrophizing.
- Changes in Kinesiophobia, levels of fear to movement. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]11 item Tampa Scale for Kinesiophobia, the final score can range between 11 and 44 points, with higher scores indicating greater perceived kinesiophobia.
- Changes in Fear-avoidance behaviours. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]Fear-avoidance Beliefs Questionnaire . The instrument consists of two subscales, a four-item physical activity subscale, and a seven-item work subscale. Each item is scored from 0 to 6 and summed to produce the subscale score. Possible scores range from 0-28 to 0-42, with higher scores indicating greater fear avoidance beliefs.
- Changes in level of Depression. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]Beck's Depression Inventory II is a 21-item self-reporting questionnaire. It scores from 0 to 21, the higher is the score the higher is the level of depression.
- Changes in patient's anxiety. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]State-Trait Anxiety Inventory. The total score ranges from 0-63 interpreted as follows: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.
- Changes in the ability to generate mental motor images. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]The Movement Imagery Questionnaire-Revised. It is an 8-item self-reporting inventory rating the difficulty of generating that image on a 7-point scale, where 1 indicates 'very difficult to see/feel' and 7 indicates 'very easy to see/feel'.
- Physical activity of the patients. [ Time Frame: Before and after the treatment (2 weeks), after 15 days and after 30 days. ]International physical activity questionnaire. Results are reported in categories depending on the variable 'MET minutes a week'. MET minutes represent the amount of energy expended carrying out physical activity. High physical activity (one hour of more of physical activity per day), moderate physical activity (half an hour of physical activity per day) or low physical activity (not meeting any of the criteria for either moderate or high levels of physical activity).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242576
|Centro superior de Estudios Universitarios La Salle|
|Madrid, Aravaca, Spain, 28023|
|Universidad Rey Juan Carlos|
|Alcorcon, Madrid, Spain, 28922|
|Principal Investigator:||David Morales Tejera, Msc., Phdc||Universidad Rey Juan Carlos|