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

November 19, 2020 updated by: Josue Fernandez Carnero

Effectiveness of Cervical Exercises Using Virtual Reality Headsets on Pain and Disability in Patients With Chronic Neck Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Universidad Rey Juan Carlos
    • Madrid, Montepríncipe
      • Madrid, Madrid, Montepríncipe, Spain, 28668
        • CEU San Pablo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality

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
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.
Active Comparator: 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.
Behavioral: Exercise
The subjects will perform evidence-based exercises for the neck.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cervical range of movement.
Time Frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Measured with goniometer by the physiotherapists.
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in pain perception.
Time Frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
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
Time Frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in levels of Catastrophism.
Time Frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
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 1 month and after 3 months.
Changes in Kinesiophobia, levels of fear to movement.
Time Frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
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 1 month and after 3 months.
Changes in Fear-avoidance behaviours.
Time Frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
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 1 month and after 3 months.
Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.
Time Frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Pressure Pain Thresholds using an algometer on first finger, trapezius muscle and tibia.
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in endogenous pain inhibition mechanisms.
Time Frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Conditioned pain modulation and temporal summation (windup), using the algometer and an occlussion band.
Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in Anxiety Related to Pain
Time Frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
20 item Pain Anxiety Symptoms Scale scoring from 0 to 100 with higher scores indicating greater pain-related anxiety.
Before and after the treatment (2 weeks), after 1 month and after 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Josue Fernandez Carnero

Collaborators

CEU San Pablo University

Investigators

  • Principal Investigator: David Morales Tejera, Msc., Phdc, Escuela Internacional de Doctorado de la Universidad Rey Juan Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

July 30, 2020

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URJC-02/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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