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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
Sponsor:
Collaborator:
Centro Universitario La Salle
Information provided by (Responsible Party):
Josue Fernandez Carnero, Universidad Rey Juan Carlos

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.

Condition or disease Intervention/treatment Phase
Pain, Neck Device: Right Left Judgement Other: Action Observation Behavioral: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Investigator)
Masking Description: Single blind
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Exercise
Evidence based exercises for the neck.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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'.


Other Outcome Measures:
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242576


Locations
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Spain
Centro superior de Estudios Universitarios La Salle
Madrid, Aravaca, Spain, 28023
Universidad Rey Juan Carlos
Alcorcon, Madrid, Spain, 28922
Sponsors and Collaborators
Josue Fernandez Carnero
Centro Universitario La Salle
Investigators
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Principal Investigator: David Morales Tejera, Msc., Phdc Universidad Rey Juan Carlos
Publications:
Murray CJ, Atkinson C, Bhalla K, Birbeck G, Burstein R, Chou D, Dellavalle R, Danaei G, Ezzati M, Fahimi A, Flaxman D, Foreman, Gabriel S, Gakidou E, Kassebaum N, Khatibzadeh S, Lim S, Lipshultz SE, London S, Lopez, MacIntyre MF, Mokdad AH, Moran A, Moran AE, Mozaffarian D, Murphy T, Naghavi M, Pope C, Roberts T, Salomon J, Schwebel DC, Shahraz S, Sleet DA, Murray, Abraham J, Ali MK, Atkinson C, Bartels DH, Bhalla K, Birbeck G, Burstein R, Chen H, Criqui MH, Dahodwala, Jarlais, Ding EL, Dorsey ER, Ebel BE, Ezzati M, Fahami, Flaxman S, Flaxman AD, Gonzalez-Medina D, Grant B, Hagan H, Hoffman H, Kassebaum N, Khatibzadeh S, Leasher JL, Lin J, Lipshultz SE, Lozano R, Lu Y, Mallinger L, McDermott MM, Micha R, Miller TR, Mokdad AA, Mokdad AH, Mozaffarian D, Naghavi M, Narayan KM, Omer SB, Pelizzari PM, Phillips D, Ranganathan D, Rivara FP, Roberts T, Sampson U, Sanman E, Sapkota A, Schwebel DC, Sharaz S, Shivakoti R, Singh GM, Singh D, Tavakkoli M, Towbin JA, Wilkinson JD, Zabetian A, Murray, Abraham J, Ali MK, Alvardo M, Atkinson C, Baddour LM, Benjamin EJ, Bhalla K, Birbeck G, Bolliger I, Burstein R, Carnahan E, Chou D, Chugh SS, Cohen A, Colson KE, Cooper LT, Couser W, Criqui MH, Dabhadkar KC, Dellavalle RP, Jarlais, Dicker D, Dorsey ER, Duber H, Ebel BE, Engell RE, Ezzati M, Felson DT, Finucane MM, Flaxman S, Flaxman AD, Fleming T, Foreman, Forouzanfar MH, Freedman G, Freeman MK, Gakidou E, Gillum RF, Gonzalez-Medina D, Gosselin R, Gutierrez HR, Hagan H, Havmoeller R, Hoffman H, Jacobsen KH, James SL, Jasrasaria R, Jayarman S, Johns N, Kassebaum N, Khatibzadeh S, Lan Q, Leasher JL, Lim S, Lipshultz SE, London S, Lopez, Lozano R, Lu Y, Mallinger L, Meltzer M, Mensah GA, Michaud C, Miller TR, Mock C, Moffitt TE, Mokdad AA, Mokdad AH, Moran A, Naghavi M, Narayan KM, Nelson RG, Olives C, Omer SB, Ortblad K, Ostro B, Pelizzari PM, Phillips D, Raju M, Razavi H, Ritz B, Roberts T, Sacco RL, Salomon J, Sampson U, Schwebel DC, Shahraz S, Shibuya K, Silberberg D, Singh JA, Steenland K, Taylor JA, Thurston GD, Vavilala MS, Vos T, Wagner GR, Weinstock MA, Weisskopf MG, Wulf S, Murray; U.S. Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA. 2013 Aug 14;310(6):591-608. doi: 10.1001/jama.2013.13805.

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Responsible Party: Josue Fernandez Carnero, Professor, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT04242576    
Other Study ID Numbers: URJC-07/2019
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josue Fernandez Carnero, Universidad Rey Juan Carlos:
Neck
Graded motor imagery
Exercise
Action Observation
Right/Left judgment tasks
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms