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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain, Pain, Neck

Intervention / Treatment
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* Device: Virtual Reality Headset
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>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<br>* 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.<br>|
| Active Comparator: Exercise<br>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<br>* The subjects will perform evidence-based exercises for the neck.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 1 month and after 3 months. | 
| 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 1 month and after 3 months. | 
| 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 1 month and after 3 months. | 
| Changes in levels of hyperalgesia to pressure and maximum pressure tolerance. | 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. | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Chronic pain, Neck pain, Physiotherapy, Exercise