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Evaluation of the Effects of Virtual Reality in Patients With Chronic Neck Pain

Primary Purpose

Chronic Pain, Pain, Neck

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual Reality Headset
Exercise
Sponsored by
Josue Fernandez Carnero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Virtual reality, Chronic pain, Neck pain, Physiotherapy, Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • CEU San Pablo
  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality

Exercise

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Changes in cervical range of movement.
Measured with goniometer by the physiotherapists.
Changes in pain perception.
Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
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.

Secondary Outcome Measures

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.
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.
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.
Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.
Pressure Pain Thresholds using an algometer on first finger, trapezius muscle and tibia.
Changes in endogenous pain inhibition mechanisms.
Conditioned pain modulation and temporal summation (windup), using the algometer and an occlussion band.
Changes in Anxiety Related to Pain
20 item Pain Anxiety Symptoms Scale scoring from 0 to 100 with higher scores indicating greater pain-related anxiety.

Full Information

First Posted
February 7, 2020
Last Updated
November 19, 2020
Sponsor
Josue Fernandez Carnero
Collaborators
CEU San Pablo University
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1. Study Identification

Unique Protocol Identification Number
NCT04265248
Brief Title
Evaluation of the Effects of Virtual Reality in Patients With Chronic Neck Pain
Official Title
Effectiveness of Cervical Exercises Using Virtual Reality Headsets on Pain and Disability in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Josue Fernandez Carnero
Collaborators
CEU San Pablo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Chronic neck pain is one of the most common causes of pain and disability. Its prevalence is approximately 15% in adults and it is one of the main causes of medical leave and the increase of drug consumption. Recent research has found 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. One of the most effective treatments for this pathology is active exercise. The main objective is the activation and strengthening of the deep flexor muscles by craniocervical flexion. It is also important to re-educate all the movements performed with the neck; extension, rotation and inclination are essential movements that also require good initial control of deep flexor muscles and its dynamism is essential to interact with our surroundings. The action observation which consists of observing an action carried out by another person is 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, it has been proved that it can produce changes in the motor cortex since the observation reinforces the cortical representation of the action, thus achieving an improvement in strength and functionality in patients with chronic pain. Taking all this into account, in this study the investigators propose the idea of working with virtual reality headset in patients with chronic neck pain. This treatment offers great visual, auditory and vestibular feedback that makes it an attractive and stimulating exercise for the patient. It has the ability to individualize treatments and patient needs. These virtual environments can graduate and increase the complexity of the task while decreasing the help and feedback provided by the therapist. The goal of a virtual reality based treatment is to make patients more participatory in their real environments as independently as possible. It is an innovative treatment that does not demand a great financial cost for its use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pain, Neck
Keywords
Virtual reality, Chronic pain, Neck pain, Physiotherapy, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Masking Description
Single Blind
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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).
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Headset
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
The subjects will perform evidence-based exercises for the neck.
Primary Outcome Measure Information:
Title
Changes in cervical range of movement.
Description
Measured with goniometer by the physiotherapists.
Time Frame
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Title
Changes in pain perception.
Description
Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
Time Frame
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Title
Changes in Neck Pain and Disability Perception
Description
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.
Time Frame
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Secondary Outcome Measure Information:
Title
Changes in levels of Catastrophism.
Description
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.
Time Frame
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Title
Changes in Kinesiophobia, levels of fear to movement.
Description
11 item Tampa Scale for Kinesiophobia, the final score can range between 11 and 44 points, with higher scores indicating greater perceived kinesiophobia.
Time Frame
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Title
Changes in Fear-avoidance behaviours.
Description
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.
Time Frame
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Title
Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.
Description
Pressure Pain Thresholds using an algometer on first finger, trapezius muscle and tibia.
Time Frame
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Title
Changes in endogenous pain inhibition mechanisms.
Description
Conditioned pain modulation and temporal summation (windup), using the algometer and an occlussion band.
Time Frame
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Title
Changes in Anxiety Related to Pain
Description
20 item Pain Anxiety Symptoms Scale scoring from 0 to 100 with higher scores indicating greater pain-related anxiety.
Time Frame
Before and after the treatment (2 weeks), after 1 month and after 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic chronic neck pain. Understands and accept the informed consent form. Meets the age limits criteria. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Morales Tejera, Msc., Phdc
Organizational Affiliation
Escuela Internacional de Doctorado de la Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEU San Pablo
City
Madrid
State/Province
Madrid, Montepríncipe
ZIP/Postal Code
28668
Country
Spain
Facility Name
Universidad Rey Juan Carlos
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27656633
Citation
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Results Reference
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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.
Results Reference
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24259936
Citation
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.
Results Reference
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PubMed Identifier
26659920
Citation
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Results Reference
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Citation
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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.
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Evaluation of the Effects of Virtual Reality in Patients With Chronic Neck Pain

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