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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265248
• Other study ID #: URJC-02/2020
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: November 2020
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 30, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain
• Pain, Neck

Intervention

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.

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

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcon	Madrid
Spain	CEU San Pablo	Madrid	Madrid, Montepríncipe

Sponsors (2)

Lead Sponsor	Collaborator
Josue Fernandez Carnero	CEU San Pablo University

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

de-la-Puente-Ranea L, García-Calvo B, La Touche R, Fernández-Carnero J, Gil-Martínez 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. — View Citation

Gallego Izquierdo T, Pecos-Martin D, Lluch Girbés E, Plaza-Manzano G, Rodríguez Caldentey R, Mayor Melús 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. — View Citation

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. — View Citation

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. — View Citation

Palacios-Ceña D, Alonso-Blanco C, Hernández-Barrera V, Carrasco-Garrido P, Jiménez-García R, Fernández-de-las-Peñas 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. — View Citation

Rudolfsson T, Djupsjöbacka M, Häger C, Björklund 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.