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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04014998
Other study ID # VR2805
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2020
Est. completion date October 10, 2021

Study information

Verified date June 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 10, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual Reality
Virtual reality group will have virtual reality for 20 minutes in addition to motor control exercises for 20 minutes. Virtual reality will apply using Oculus Go. On the other hand control group will have only exercise for 40 minutes. Exercises will include same exercises in both groups, but exercise group will perform exercises twice compared to virtual reality group.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Li A, Montaño Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Joint position sense error will assessed by Cervical Range of Motion device. Joint position sense error will assessed by Cervical Range of Motion device. Change from baseline joint position sense error (cervical flexion, extension, lateral flexions and rotations) after 6 weeks.
Primary Balance will assessed by Dynamic Posturography. Balance will assessed by Dynamic Posturography. 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 cervical lordosis angle Angle will measure using the plane of the superior vertebral plateau of C7 vertebra and of the inferior plateau of C2. Change from baseline cervical lordosis after 6 weeks.
Secondary Kinesiophobia will assessed by Tampa kinesiophobia Scale Kinesiophobia will assessed by Tampa kinesiophobia Scale Change from baseline kinesiophobia after 6 weeks.
Secondary Quality of life will assessed by Short-form 36. Quality of life will assessed by Short-form 36. Change from baseline quality of life after 6 weeks.
Secondary Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish). Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish). Change from baseline disability after 6 weeks.
Secondary Anxiety-depression will assessed by Hospital Anxiety-depression scale. Anxiety-depression will assessed by Hospital Anxiety-depression scale. Change from baseline anxiety-depression after 6 weeks.
Secondary Shoulder protraction and forward head posture were assessed by photography method. Shoulder protraction and forward head posture were assessed by photography method. Change from baseline shoulder protraction and forward head posture after 6 weeks.
Secondary Pain threshold will assessed by algometer device. Pain threshold will assessed by algometer device. 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.
Secondary Pain intensity will assessed with Visual Analog Scale. Pain intensity will assessed with Visual Analog Scale. Change from baseline pain intensity after 6 weeks.
Secondary muscle strength will assessed by dynamometer and biofeedback device muscle strength will assessed by dynamometer and biofeedback device Change from baseline muscle strength after 6 weeks.
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