Effectiveness of Virtual Reality in Patients With Chronic Neck Pain

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT04014998
Collaborator
(none)
40
1
2
11.3
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual Reality
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Virtual RealityVirtual Reality
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effectiveness of Virtual Reality Applications in Addition to Exercise Program in People With Chronic Neck Pain
Actual Study Start Date :
Oct 30, 2020
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Oct 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality

Virtual Reality + Exercise

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.
Other Names:
  • Exercise
  • Other: Exercise

    Exercise Only

    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.
    Other Names:
  • Exercise
  • Outcome Measures

    Primary Outcome Measures

    1. 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.]

      Joint position sense error will assessed by Cervical Range of Motion device.

    2. 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.]

      Balance will assessed by Dynamic Posturography.

    Secondary Outcome Measures

    1. cervical lordosis angle [Change from baseline cervical lordosis after 6 weeks.]

      Angle will measure using the plane of the superior vertebral plateau of C7 vertebra and of the inferior plateau of C2.

    2. Kinesiophobia will assessed by Tampa kinesiophobia Scale [Change from baseline kinesiophobia after 6 weeks.]

      Kinesiophobia will assessed by Tampa kinesiophobia Scale

    3. Quality of life will assessed by Short-form 36. [Change from baseline quality of life after 6 weeks.]

      Quality of life will assessed by Short-form 36.

    4. Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish). [Change from baseline disability after 6 weeks.]

      Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish).

    5. Anxiety-depression will assessed by Hospital Anxiety-depression scale. [Change from baseline anxiety-depression after 6 weeks.]

      Anxiety-depression will assessed by Hospital Anxiety-depression scale.

    6. Shoulder protraction and forward head posture were assessed by photography method. [Change from baseline shoulder protraction and forward head posture after 6 weeks.]

      Shoulder protraction and forward head posture were assessed by photography method.

    7. 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.]

      Pain threshold will assessed by algometer device.

    8. Pain intensity will assessed with Visual Analog Scale. [Change from baseline pain intensity after 6 weeks.]

      Pain intensity will assessed with Visual Analog Scale.

    9. muscle strength will assessed by dynamometer and biofeedback device [Change from baseline muscle strength after 6 weeks.]

      muscle strength will assessed by dynamometer and biofeedback device

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University Ankara Turkey

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    • Study Director: Halil Kamil Öge, Hacettepe University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    HATİCE ÇETİN, Research Assisstant, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT04014998
    Other Study ID Numbers:
    • VR2805
    First Posted:
    Jul 10, 2019
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by HATİCE ÇETİN, Research Assisstant, Hacettepe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 1, 2022