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Evaluation of Nociceptive Processing in the Cervical Region

Primary Purpose

Pain, Neck

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Right Left Judgement
Action Observation
Exercise
Sponsored by
Josue Fernandez Carnero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Neck focused on measuring Neck, Graded motor imagery, Exercise, Action Observation, Right/Left judgment tasks

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Centro superior de Estudios Universitarios La Salle
  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Action Observation

Right/Left Judgment Task

Exercise

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes in cervical range of movement.
Measured with goniometer by the physiotherapists.
Changes in pain perception.
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.
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.
Mechanical nociceptive threshold test using Von-Frey filaments.
Changes in upper Limb Neurodinamics.
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.
Pressure Pain Tresholds using an algometer on first finger, trapezius muscle and tibia.
Changes in endogenous pain inhibition mechanisms.
Conditioned pain modulation and temporal summation (windup), using the algometer and an oclussion band.
Changes in pain to cold threshold.
Cold stimulation test using cold compresses on the cervical region two times during 10 minutes.
Changes in deep neck flexors activation.
Deep neck flexor endurance test.
Changes in hand and forearm muscular strenght.
Handgrip strenght test using a dynamometer.

Secondary Outcome Measures

Changes in levels of Catastrophism.
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.
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.
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.
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.
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.
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'.

Full Information

First Posted
December 20, 2019
Last Updated
January 22, 2020
Sponsor
Josue Fernandez Carnero
Collaborators
Centro Universitario La Salle
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1. Study Identification

Unique Protocol Identification Number
NCT04242576
Brief Title
Evaluation of Nociceptive Processing in the Cervical Region
Official Title
Evaluation of Nociceptive Processing in the Cervical Region Through Action Observation, Laterality Discrimination and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Josue Fernandez Carnero
Collaborators
Centro Universitario La Salle

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neck
Keywords
Neck, Graded motor imagery, Exercise, Action Observation, Right/Left judgment tasks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Masking Description
Single blind
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Action Observation
Arm Type
Experimental
Arm Description
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.
Arm Title
Right/Left Judgment Task
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Right Left Judgement
Other Intervention Name(s)
Recognise® by Noigroup
Intervention Description
It is an application by Noigroup (Neuro Orthopedic Institute), adapted to different devices.
Intervention Type
Other
Intervention Name(s)
Action Observation
Intervention Description
Videos of cervical movements.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Evidence based exercises for the neck.
Primary Outcome Measure Information:
Title
Changes in cervical range of movement.
Description
Measured with goniometer by the physiotherapists.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in pain perception.
Description
Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in the subject's selective attention capacity and skills as well as their processing speed ability.
Description
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.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in pain treshold perception.
Description
Mechanical nociceptive threshold test using Von-Frey filaments.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in upper Limb Neurodinamics.
Description
Upper limb neurodinamics test measuring with a goniometer on what grade of joint movement with nerve stretching pain appears.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.
Description
Pressure Pain Tresholds using an algometer on first finger, trapezius muscle and tibia.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in endogenous pain inhibition mechanisms.
Description
Conditioned pain modulation and temporal summation (windup), using the algometer and an oclussion band.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in pain to cold threshold.
Description
Cold stimulation test using cold compresses on the cervical region two times during 10 minutes.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in deep neck flexors activation.
Description
Deep neck flexor endurance test.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in hand and forearm muscular strenght.
Description
Handgrip strenght test using a dynamometer.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Secondary Outcome Measure Information:
Title
Changes in levels of Catastrophism.
Description
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.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in Kinesiophobia, levels of fear to movement.
Description
11 item Tampa Scale for Kinesiophobia, the final score can range between 11 and 44 points, with higher scores indicating greater perceived kinesiophobia.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in Fear-avoidance behaviours.
Description
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.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in level of Depression.
Description
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.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in patient's anxiety.
Description
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.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Title
Changes in the ability to generate mental motor images.
Description
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'.
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.
Other Pre-specified Outcome Measures:
Title
Physical activity of the patients.
Description
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).
Time Frame
Before and after the treatment (2 weeks), after 15 days and after 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers. Asymptomatic on cervical region. Understands and accept the informed consent. Spanish speakers. People with no cognitive disorders. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Morales Tejera, Msc., Phdc
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro superior de Estudios Universitarios La Salle
City
Madrid
State/Province
Aravaca
ZIP/Postal Code
28023
Country
Spain
Facility Name
Universidad Rey Juan Carlos
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23842577
Citation
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Evaluation of Nociceptive Processing in the Cervical Region

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