Pain, NeckNCT04242576
Evaluation of Nociceptive Processing in the Cervical Region
A study testing Right Left Judgement, Action Observation and Exercise in people with Pain, Neck, run by Josue Fernandez Carnero at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Neck
- What is being tested?
- Right Left Judgement, Action Observation and Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Dec 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers.
- Asymptomatic on cervical region.
- Understands and accept the informed consent.
- Spanish speakers.
- People with no cognitive disorders.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
Centro superior de Estudios Universitarios La Salle
Madrid, Aravaca, 28023
About this study
Official title: Evaluation of Nociceptive Processing in the Cervical Region Through Action Observation, Laterality Discrimination and Exercise
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.
Read the 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.
- Conditions
- Pain, Neck
- Being tested
- Right Left Judgement, Action Observation, Exercise
- Keywords
- Neck, Graded motor imagery, Exercise, Action Observation, Right/Left judgment tasks
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Left JudgementDevice
Also called Recognise® by Noigroup
It is an application by Noigroup (Neuro Orthopedic Institute), adapted to different devices.
Action ObservationOther
Videos of cervical movements.
ExerciseBehavioural
Evidence based exercises for the neck.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Action Observation |
| 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. Receives: Device: Right Left Judgement |
| 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cervical range of movement.
Measured with goniometer by the physiotherapists.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in pain perception.
Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
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.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in pain treshold perception.
Mechanical nociceptive threshold test using Von-Frey filaments.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in upper Limb Neurodinamics.
Upper limb neurodinamics test measuring with a goniometer on what grade of joint movement with nerve stretching pain appears.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.
Pressure Pain Tresholds using an algometer on first finger, trapezius muscle and tibia.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in endogenous pain inhibition mechanisms.
Conditioned pain modulation and temporal summation (windup), using the algometer and an oclussion band.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in pain to cold threshold.
Cold stimulation test using cold compresses on the cervical region two times during 10 minutes.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in deep neck flexors activation.
Deep neck flexor endurance test.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in hand and forearm muscular strenght.
Handgrip strenght test using a dynamometer.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Secondary outcomes (6)
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.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
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.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
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.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
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.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
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.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
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'.
Measured: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Dec 2018
- Primary completion30 Jul 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain, NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josue Fernandez Carnero
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario La Salle
- Responsible party
- Sponsor-investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- David Morales Tejera, Msc., Phdc, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242576
- Sponsor's protocol ID
- URJC-07/2019
- Status last verified
- Jan 2020
- First submitted
- 20 Dec 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23842577Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
PubMed 15999284Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
PubMed 25659245Falla D, Jull G, Russell T, Vicenzino B, Hodges P. Effect of neck exercise on sitting posture in patients with chronic neck pain. Phys Ther. 2007 Apr;87(4):408-17. doi: 10.2522/ptj.20060009. Epub 2007 Mar 6.
PubMed 17341512Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
PubMed 28807894Kay TM, Gross A, Goldsmith CH, Rutherford S, Voth S, Hoving JL, Bronfort G, Santaguida PL. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD004250. doi: 10.1002/14651858.CD004250.pub4.
PubMed 22895940Losana-Ferrer A, Manzanas-Lopez S, Cuenca-Martinez F, Paris-Alemany A, La Touche R. Effects of motor imagery and action observation on hand grip strength, electromyographic activity and intramuscular oxygenation in the hand gripping gesture: A randomized controlled trial. Hum Mov Sci. 2018 Apr;58:119-131. doi: 10.1016/j.humov.2018.01.011. Epub 2018 Mar 12.
PubMed 29408163La Touche R, Grande-Alonso M, Cuenca-Martinez F, Gonzalez-Ferrero L, Suso-Marti L, Paris-Alemany A. Diminished Kinesthetic and Visual Motor Imagery Ability in Adults With Chronic Low Back Pain. PM R. 2019 Mar;11(3):227-235. doi: 10.1016/j.pmrj.2018.05.025. Epub 2019 Jan 15.
PubMed 29908933Schmid AB, Coppieters MW. Left/right judgment of body parts is selectively impaired in patients with unilateral carpal tunnel syndrome. Clin J Pain. 2012 Sep;28(7):615-22. doi: 10.1097/AJP.0b013e31823e16b9.
PubMed 22688599Wallwork SB, Butler DS, Fulton I, Stewart H, Darmawan I, Moseley GL. Left/right neck rotation judgments are affected by age, gender, handedness and image rotation. Man Ther. 2013 Jun;18(3):225-30. doi: 10.1016/j.math.2012.10.006. Epub 2013 Jan 26.
PubMed 23357411
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nociceptive Processing in the Cervical Region Through Action Observation, Laterality Discrimination and Exercise
- ClinicalTrials.gov ID
- NCT04242576
- Acronym / sponsor ID
- URJC-07/2019
- Conditions
- Pain, Neck
- Keywords
- Neck, Graded motor imagery, Exercise, Action Observation, Right/Left judgment tasks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Josue Fernandez CarneroUniversity, hospital or other
- Collaborators
- Centro Universitario La Salle
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Action Observation | Experimental | Other: Action ObservationSubjects 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. |
| Right/Left Judgment Task | Experimental | Device: Right Left JudgementThe 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. |
| Exercise | Active comparator | Behavioral: ExerciseThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteers.
- Asymptomatic on cervical region.
- Understands and accept the informed consent.
- Spanish speakers.
- People with no cognitive disorders.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Left JudgementAlso: Recognise® by NoigroupIt is an application by Noigroup (Neuro Orthopedic Institute), adapted to different devices. | Device | Right/Left Judgment Task |
| Action ObservationVideos of cervical movements. | Other | Action Observation |
| ExerciseEvidence based exercises for the neck. | Behavioural | Exercise |
Primary outcome
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.
6 secondary outcomes
Changes in levels of Catastrophism.
Time frame: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in Kinesiophobia, levels of fear to movement.
Time frame: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in Fear-avoidance behaviours.
Time frame: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in level of Depression.
Time frame: Before and after the treatment (2 weeks), after 15 days and after 30 days.
Changes in patient's anxiety.
Time frame: Before and after the treatment (2 weeks), after 15 days and after 30 days.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 23842577Murray 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.
- Background: PubMed 15999284Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
- Background: PubMed 25659245Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
- Background: PubMed 17341512Falla D, Jull G, Russell T, Vicenzino B, Hodges P. Effect of neck exercise on sitting posture in patients with chronic neck pain. Phys Ther. 2007 Apr;87(4):408-17. doi: 10.2522/ptj.20060009. Epub 2007 Mar 6.
- Background: PubMed 28807894Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
- Background: PubMed 22895940Kay TM, Gross A, Goldsmith CH, Rutherford S, Voth S, Hoving JL, Bronfort G, Santaguida PL. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD004250. doi: 10.1002/14651858.CD004250.pub4.
- Background: PubMed 29408163Losana-Ferrer A, Manzanas-Lopez S, Cuenca-Martinez F, Paris-Alemany A, La Touche R. Effects of motor imagery and action observation on hand grip strength, electromyographic activity and intramuscular oxygenation in the hand gripping gesture: A randomized controlled trial. Hum Mov Sci. 2018 Apr;58:119-131. doi: 10.1016/j.humov.2018.01.011. Epub 2018 Mar 12.
- Background: PubMed 29908933La Touche R, Grande-Alonso M, Cuenca-Martinez F, Gonzalez-Ferrero L, Suso-Marti L, Paris-Alemany A. Diminished Kinesthetic and Visual Motor Imagery Ability in Adults With Chronic Low Back Pain. PM R. 2019 Mar;11(3):227-235. doi: 10.1016/j.pmrj.2018.05.025. Epub 2019 Jan 15.
- Background: PubMed 22688599Schmid AB, Coppieters MW. Left/right judgment of body parts is selectively impaired in patients with unilateral carpal tunnel syndrome. Clin J Pain. 2012 Sep;28(7):615-22. doi: 10.1097/AJP.0b013e31823e16b9.
- Background: PubMed 23357411Wallwork SB, Butler DS, Fulton I, Stewart H, Darmawan I, Moseley GL. Left/right neck rotation judgments are affected by age, gender, handedness and image rotation. Man Ther. 2013 Jun;18(3):225-30. doi: 10.1016/j.math.2012.10.006. Epub 2013 Jan 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Morales Tejera, Msc., Phdc principal investigator
Universidad Rey Juan Carlos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Left Judgement, Action Observation and Exercise in people with Pain, Neck, run by Josue Fernandez Carnero at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cervical range of movement. (time frame: Before and after the treatment (2 weeks), after 15 days and after 30 days.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242576, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.