NCT04265248

Brief Summary

The main objective of this research is to assess the effectiveness of virtual reality as a treatment to reduce pain and disability in patients with chronic neck pain compared to a regular exercise program for the neck.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

February 7, 2020

Last Update Submit

November 19, 2020

Conditions

Chronic PainPain, Neck

Keywords

Virtual realityChronic painNeck painPhysiotherapyExercise

Outcome Measures

Primary Outcomes (3)

  • Changes in cervical range of movement.

    Measured with goniometer by the physiotherapists.

    Before and after the treatment (2 weeks), after 1 month and after 3 months.

  • 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 1 month and after 3 months.

  • Changes in Neck Pain and Disability Perception

    10 Neck Disability Index Scale that must be answered with a numeric value between 0 (no disability) and 5 (complete disability), with a maximum score of 50 points, with higher scores indicating greater neck disability.

    Before and after the treatment (2 weeks), after 1 month and after 3 months.

Secondary Outcomes (6)

  • Changes in levels of Catastrophism.

    Before and after the treatment (2 weeks), after 1 month and after 3 months.

  • Changes in Kinesiophobia, levels of fear to movement.

    Before and after the treatment (2 weeks), after 1 month and after 3 months.

  • Changes in Fear-avoidance behaviours.

    Before and after the treatment (2 weeks), after 1 month and after 3 months.

  • Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.

    Before and after the treatment (2 weeks), after 1 month and after 3 months.

  • Changes in endogenous pain inhibition mechanisms.

    Before and after the treatment (2 weeks), after 1 month and after 3 months.

  • +1 more secondary outcomes

Study Arms (2)

Virtual Reality

EXPERIMENTAL

The subjects will use "Fulldive VR" as the first degree of difficulty where only tilt movements are necessary, for the second degree of difficulty the game "VR Ocean Aquarium 3D" will be used, where bending, extension and rotation movements will be integrated, also introducing a sensory element to integrate the sound of the sea. For these patients to perform the same work as group 2, the physiotherapist will have to count and control in each exercise the number of movements that the patient performs so as not to exceed the proposed dose in the active comparator group (3 sets of 10 repetitions of each exercise).

Device: Virtual Reality Headset

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

Virtual Reality HeadsetDEVICE

The subjects will wear the Virtual Reality Headset with a mobile phone inserted into it with the applications Full Dive VR and VR Ocean Aquarium 3D.

Virtual Reality
ExerciseBEHAVIORAL

The subjects will perform evidence-based exercises for the neck.

Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic chronic neck pain.
  • Understands and accept the informed consent form.
  • Meets the age limits criteria.

You may not qualify if:

  • Patients under 18 or over 65 years old.
  • Pregnancy.
  • Specific neck pain due to metastases, neoplasms, infectious or inflammatory. processes, fractures, or traumatic history of cervical injury.
  • Positive neurological signs or evidence of spinal cord compression (abnormal diffuse sensitivity, hyperreflexia or diffuse weakness).
  • Cervical osteoarthritis.
  • Polyarthrosis.
  • Neck Pain associated with vertigo (vestibular involvement).
  • Neck Pain associated with whiplash injuries.
  • Previous cervical surgeries.
  • Headaches before cervicalgia without cervical origin.
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

CEU San Pablo

Madrid, Madrid, Montepríncipe, 28668, Spain

Location

Related Publications (10)

  • de-la-Puente-Ranea L, Garcia-Calvo B, La Touche R, Fernandez-Carnero J, Gil-Martinez A. Influence of the actions observed on cervical motion in patients with chronic neck pain: a pilot study. J Exerc Rehabil. 2016 Aug 31;12(4):346-54. doi: 10.12965/jer.1632636.318. eCollection 2016 Aug.

    PMID: 27656633BACKGROUND

  • Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.

    PMID: 26957772BACKGROUND

  • Borisut S, Vongsirinavarat M, Vachalathiti R, Sakulsriprasert P. Effects of strength and endurance training of superficial and deep neck muscles on muscle activities and pain levels of females with chronic neck pain. J Phys Ther Sci. 2013 Sep;25(9):1157-62. doi: 10.1589/jpts.25.1157. Epub 2013 Oct 20.

    PMID: 24259936BACKGROUND

  • Gallego Izquierdo T, Pecos-Martin D, Lluch Girbes E, Plaza-Manzano G, Rodriguez Caldentey R, Mayor Melus R, Blanco Mariscal D, Falla D. Comparison of cranio-cervical flexion training versus cervical proprioception training in patients with chronic neck pain: A randomized controlled clinical trial. J Rehabil Med. 2016 Jan;48(1):48-55. doi: 10.2340/16501977-2034.

    PMID: 26659920BACKGROUND

  • Sarig Bahat H, Weiss PL, Sprecher E, Krasovsky A, Laufer Y. Do neck kinematics correlate with pain intensity, neck disability or with fear of motion? Man Ther. 2014 Jun;19(3):252-8. doi: 10.1016/j.math.2013.10.006. Epub 2013 Nov 9.

    PMID: 24291364BACKGROUND

  • Palacios-Cena D, Alonso-Blanco C, Hernandez-Barrera V, Carrasco-Garrido P, Jimenez-Garcia R, Fernandez-de-las-Penas C. Prevalence of neck and low back pain in community-dwelling adults in Spain: an updated population-based national study (2009/10-2011/12). Eur Spine J. 2015 Mar;24(3):482-92. doi: 10.1007/s00586-014-3567-5. Epub 2014 Sep 11.

    PMID: 25208501BACKGROUND

  • Nederhand MJ, Ijzerman MJ, Hermens HJ, Turk DC, Zilvold G. Predictive value of fear avoidance in developing chronic neck pain disability: consequences for clinical decision making. Arch Phys Med Rehabil. 2004 Mar;85(3):496-501. doi: 10.1016/j.apmr.2003.06.019.

    PMID: 15031840BACKGROUND

  • Rudolfsson T, Djupsjobacka M, Hager C, Bjorklund M. Effects of neck coordination exercise on sensorimotor function in chronic neck pain: a randomized controlled trial. J Rehabil Med. 2014 Oct;46(9):908-14. doi: 10.2340/16501977-1869.

    PMID: 25182501BACKGROUND

  • Sarig Bahat H, Sprecher E, Sela I, Treleaven J. Neck motion kinematics: an inter-tester reliability study using an interactive neck VR assessment in asymptomatic individuals. Eur Spine J. 2016 Jul;25(7):2139-48. doi: 10.1007/s00586-016-4388-5. Epub 2016 Jan 30.

    PMID: 26831536BACKGROUND

  • Sarig Bahat H, Takasaki H, Chen X, Bet-Or Y, Treleaven J. Cervical kinematic training with and without interactive VR training for chronic neck pain - a randomized clinical trial. Man Ther. 2015 Feb;20(1):68-78. doi: 10.1016/j.math.2014.06.008. Epub 2014 Jul 5.

    PMID: 25066503BACKGROUND

MeSH Terms

Conditions

Chronic PainNeck PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David Morales Tejera, Msc., Phdc

    Escuela Internacional de Doctorado de la 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

February 7, 2020

First Posted

February 11, 2020

Study Start

January 1, 2020

Primary Completion

March 20, 2020

Study Completion

July 30, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)