Evaluation of Nociceptive Processing in the Cervical Region

Pain, Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242576
• Other study ID #: URJC-07/2019
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2020
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain
• Pain, Neck

Intervention

Device:
• Right Left Judgement
It is an application by Noigroup (Neuro Orthopedic Institute), adapted to different devices.

Other:
• Action Observation
Videos of cervical movements.

Behavioral:
• Exercise
Evidence based exercises for the neck.

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcon	Madrid
Spain	Centro superior de Estudios Universitarios La Salle	Madrid	Aravaca

Sponsors (2)

Lead Sponsor	Collaborator
Josue Fernandez Carnero	Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221. Review. — View Citation

Cohen 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. Review. — View Citation

Falla 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. Epub 2007 Mar 6. — View Citation

Fejer 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. Epub 2005 Jul 6. Review. — View Citation

Kay TM, Gross A, Goldsmith CH, Rutherford S, Voth S, Hoving JL, Brønfort G, Santaguida PL. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD004250. doi: 10.1002/14651858.CD004250.pub4. Review. Update in: Cochrane Database Syst Rev. 2015;1:CD004250. — View Citation

La Touche R, Grande-Alonso M, Cuenca-Martínez F, Gónzález-Ferrero L, Suso-Martí 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. — View Citation

Losana-Ferrer A, Manzanas-López S, Cuenca-Martínez 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. — View Citation

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. — View Citation

Schmid 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. — View Citation

Wallwork 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity of the patients.	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).	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	Changes in cervical range of movement.	Measured with goniometer by the physiotherapists.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	Changes in pain perception.	Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	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.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	Changes in pain treshold perception.	Mechanical nociceptive threshold test using Von-Frey filaments.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	Changes in upper Limb Neurodinamics.	Upper limb neurodinamics test measuring with a goniometer on what grade of joint movement with nerve stretching pain appears.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.	Pressure Pain Tresholds using an algometer on first finger, trapezius muscle and tibia.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	Changes in endogenous pain inhibition mechanisms.	Conditioned pain modulation and temporal summation (windup), using the algometer and an oclussion band.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	Changes in pain to cold threshold.	Cold stimulation test using cold compresses on the cervical region two times during 10 minutes.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	Changes in deep neck flexors activation.	Deep neck flexor endurance test.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Primary	Changes in hand and forearm muscular strenght.	Handgrip strenght test using a dynamometer.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Secondary	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.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Secondary	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.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Secondary	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.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Secondary	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.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Secondary	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.	Before and after the treatment (2 weeks), after 15 days and after 30 days.
Secondary	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'.	Before and after the treatment (2 weeks), after 15 days and after 30 days.