Clinical trial NCT04265248: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Pain, Neck
Keywords: Virtual reality
Chronic pain
Neck pain
Physiotherapy
Exercise
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: CEU San Pablo University
First posted: 2020-02-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in cervical range of movement.
timeFrame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
measure: Changes in pain perception.
timeFrame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
measure: Changes in Neck Pain and Disability Perception
timeFrame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Secondary outcomes:
measure: Changes in levels of Catastrophism.
timeFrame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
measure: Changes in Kinesiophobia, levels of fear to movement.
timeFrame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
measure: Changes in Fear-avoidance behaviours.
timeFrame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
measure: Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.
timeFrame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
measure: Changes in endogenous pain inhibition mechanisms.
timeFrame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
measure: Changes in Anxiety Related to Pain
timeFrame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CEU San Pablo
state: Madrid, Montepríncipe
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Escuela Internacional de Doctorado de la Universidad Rey Juan Carlos
name: David Morales Tejera, Msc., Phdc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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