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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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).
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.
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 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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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