Evaluation of Nociceptive Processing in the Cervical Region

NCT04242576 | Completed DMC

• 1 other identifier: URJC-07/2019
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Neck

Keywords

Neck; Graded motor imagery; Exercise; Action Observation; Right/Left judgment tasks

Outcome Measures

Primary Outcomes (10)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (6)

• Changes in levels of Catastrophism.

  Before and after the treatment (2 weeks), after 15 days and after 30 days.

• Changes in Kinesiophobia, levels of fear to movement.

  Before and after the treatment (2 weeks), after 15 days and after 30 days.

• Changes in Fear-avoidance behaviours.

  Before and after the treatment (2 weeks), after 15 days and after 30 days.

• Changes in level of Depression.

  Before and after the treatment (2 weeks), after 15 days and after 30 days.

• Changes in patient's anxiety.

  Before and after the treatment (2 weeks), after 15 days and after 30 days.

Other Outcomes (1)

• Physical activity of the patients.

  Before and after the treatment (2 weeks), after 15 days and after 30 days.

Study Arms (3)

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.

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.

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.

Behavioral: Exercise

Interventions

Right Left Judgement DEVICE

It is an application by Noigroup (Neuro Orthopedic Institute), adapted to different devices.

Also known as: Recognise® by Noigroup

Right/Left Judgment Task

Action Observation OTHER

Videos of cervical movements.

Action Observation

Exercise BEHAVIORAL

Evidence based exercises for the neck.

Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Josue Fernandez Carnero: lead
• Centro Universitario La Salle: collaborator

Study Sites (2)

Centro superior de Estudios Universitarios La Salle

Madrid, Aravaca, 28023, Spain

Location

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (10)

• 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.

  PMID: 23842577 BACKGROUND

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  PMID: 15999284 BACKGROUND

• 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.

  PMID: 25659245 BACKGROUND

• 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. doi: 10.2522/ptj.20060009. Epub 2007 Mar 6.

  PMID: 17341512 BACKGROUND

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

  PMID: 28807894 BACKGROUND

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  PMID: 22895940 BACKGROUND

• Losana-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.

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• La 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Neck Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David Morales Tejera, Msc., Phdc

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 27, 2020
• Study Start: December 20, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)