Clinical trial NCT04014998: Effectiveness of Virtual Reality in Patients With Chronic Neck Pain
Official title: Investigation of the Effectiveness of Virtual Reality Applications in Addition to Exercise Program in People With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Neck
Virtual Reality
Proprioception
Balance
Keywords: neck pain
virtual reality
proprioception
balance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Virtual Reality
Primary purpose: TREATMENT

Brief summary: Virtual reality application has been increasing in recent years for pain control, distraction in wound care, treatment of anxiety disorders and support for physical rehabilitation. For example, it has been found to be effective in reducing pain when used in addition to medical treatment during bandaging of severe burns. The studies related with chronic pain patients were stated that virtual reality application was found to be interactive and fun by patients. Therefore, The aim of this study was to investigate the effects of virtual reality on pain threshold, disability, balance, proprioception, exercise sustainability, muscular performance in neck region, quality of life and anxiety / depression in addition to the exercise program that includes stabilization exercises in patients with chronic neck pain.


Eligibility criteria: Inclusion Criteria:

* to have pain more than 3 months,
* to be sedentary,
* to have Neck Disability Index score more than 10.

Exclusion Criteria:

* to have neurological deficits, vestibular pathology, history of surgery.

Primary outcomes:
measure: Joint position sense error will assessed by Cervical Range of Motion device.
timeFrame: Change from baseline joint position sense error (cervical flexion, extension, lateral flexions and rotations) after 6 weeks.
measure: Balance will assessed by Dynamic Posturography.
timeFrame: Change from baseline sensorial organization test (vestibular, visual and proprioceptive components), limits of stability (reaction time, movement velocity, endpoint excursion, maximum excursion, directional control) and unilateral stance after 6 weeks.
Secondary outcomes:
measure: cervical lordosis angle
timeFrame: Change from baseline cervical lordosis after 6 weeks.
measure: Kinesiophobia will assessed by Tampa kinesiophobia Scale
timeFrame: Change from baseline kinesiophobia after 6 weeks.
measure: Quality of life will assessed by Short-form 36.
timeFrame: Change from baseline quality of life after 6 weeks.
measure: Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish).
timeFrame: Change from baseline disability after 6 weeks.
measure: Anxiety-depression will assessed by Hospital Anxiety-depression scale.
timeFrame: Change from baseline anxiety-depression after 6 weeks.
measure: Shoulder protraction and forward head posture were assessed by photography method.
timeFrame: Change from baseline shoulder protraction and forward head posture after 6 weeks.
measure: Pain threshold will assessed by algometer device.
timeFrame: Change from baseline pain threshold of both the right and left upper trapezius, the right and left articular pillar between cervical 1 and 2, the right and left cervical 5 and 6 after 6 weeks.
measure: Pain intensity will assessed with Visual Analog Scale.
timeFrame: Change from baseline pain intensity after 6 weeks.
measure: muscle strength will assessed by dynamometer and biofeedback device
timeFrame: Change from baseline muscle strength after 6 weeks.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Halil Kamil Öge
role: STUDY_DIRECTOR
References:
citation: Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
citation: Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.