- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04014998
Effectiveness of Virtual Reality in Patients With Chronic Neck Pain
June 28, 2022 updated by: HATİCE ÇETİN, Hacettepe University
Investigation of the Effectiveness of Virtual Reality Applications in Addition to Exercise Program in People With Chronic Neck Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality
Virtual Reality + Exercise
|
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:
|
|
Other: Exercise
Exercise Only
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cervical lordosis angle
Time Frame: 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.
|
Change from baseline cervical lordosis after 6 weeks.
|
|
Kinesiophobia will assessed by Tampa kinesiophobia Scale
Time Frame: Change from baseline kinesiophobia after 6 weeks.
|
Kinesiophobia will assessed by Tampa kinesiophobia Scale
|
Change from baseline kinesiophobia after 6 weeks.
|
|
Quality of life will assessed by Short-form 36.
Time Frame: Change from baseline quality of life after 6 weeks.
|
Quality of life will assessed by Short-form 36.
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Change from baseline quality of life after 6 weeks.
|
|
Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish).
Time Frame: Change from baseline disability after 6 weeks.
|
Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish).
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Change from baseline disability after 6 weeks.
|
|
Anxiety-depression will assessed by Hospital Anxiety-depression scale.
Time Frame: Change from baseline anxiety-depression after 6 weeks.
|
Anxiety-depression will assessed by Hospital Anxiety-depression scale.
|
Change from baseline anxiety-depression after 6 weeks.
|
|
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.
|
Shoulder protraction and forward head posture were assessed by photography method.
|
Change from baseline shoulder protraction and forward head posture after 6 weeks.
|
|
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.
|
Pain threshold will assessed by algometer device.
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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.
|
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Pain intensity will assessed with Visual Analog Scale.
Time Frame: Change from baseline pain intensity after 6 weeks.
|
Pain intensity will assessed with Visual Analog Scale.
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Change from baseline pain intensity after 6 weeks.
|
|
muscle strength will assessed by dynamometer and biofeedback device
Time Frame: Change from baseline muscle strength after 6 weeks.
|
muscle strength will assessed by dynamometer and biofeedback device
|
Change from baseline muscle strength after 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Halil Kamil Öge, Hacettepe University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2020
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
October 10, 2021
Study Registration Dates
First Submitted
July 5, 2019
First Submitted That Met QC Criteria
July 9, 2019
First Posted (Actual)
July 10, 2019
Study Record Updates
Last Update Posted (Actual)
July 1, 2022
Last Update Submitted That Met QC Criteria
June 28, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR2805
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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