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Effectiveness of Virtual Reality in Patients With Chronic Neck Pain

Primary Purpose

Pain, Neck, Virtual Reality, Proprioception

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Neck focused on measuring neck pain, virtual reality, proprioception, balance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Virtual Reality

Exercise

Arm Description

Virtual Reality + Exercise

Exercise Only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

cervical lordosis angle
Angle will measure using the plane of the superior vertebral plateau of C7 vertebra and of the inferior plateau of C2.
Kinesiophobia will assessed by Tampa kinesiophobia Scale
Kinesiophobia will assessed by Tampa kinesiophobia Scale
Quality of life will assessed by Short-form 36.
Quality of life will assessed by Short-form 36.
Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish).
Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish).
Anxiety-depression will assessed by Hospital Anxiety-depression scale.
Anxiety-depression will assessed by Hospital Anxiety-depression scale.
Shoulder protraction and forward head posture were assessed by photography method.
Shoulder protraction and forward head posture were assessed by photography method.
Pain threshold will assessed by algometer device.
Pain threshold will assessed by algometer device.
Pain intensity will assessed with Visual Analog Scale.
Pain intensity will assessed with Visual Analog Scale.
muscle strength will assessed by dynamometer and biofeedback device
muscle strength will assessed by dynamometer and biofeedback device

Full Information

First Posted
July 5, 2019
Last Updated
June 28, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04014998
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neck, Virtual Reality, Proprioception, Balance
Keywords
neck pain, virtual reality, proprioception, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Virtual Reality
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil Kamil Öge
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
28356241
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.
Results Reference
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PubMed Identifier
21779307
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.
Results Reference
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Effectiveness of Virtual Reality in Patients With Chronic Neck Pain

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