Virtual Reality and Cervical Mobilization

March 27, 2024 updated by: HATİCE ÇETİN, Hacettepe University

Comparison of the Effects of Virtual Reality and Cervical Mobilization in Individuals With Chronic Neck Pain

The aim of this study is to compare the effects of virtual reality and cervical mobilization on proprioception, balance parameters, pain, disability level, quality of life and overall felt effect in individuals with chronic neck pain. In addition, it is aimed to qualitatively evaluate the virtual reality perspectives of individuals 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.
52

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neck pain persisting for at least 3 months
  • Being between the ages of 18-65,
  • Being sedentary (not included in any physical therapy program in the last 6 months), ->10 points from the Neck Disability Index

Exclusion Criteria:

  • History of previous spinal surgery
  • Neurological, cardiopulmonary, musculoskeletal disease affecting physical performance
  • Any pathology in the shoulder joint
  • Spinal trauma history
  • Pregnancy

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: Single

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+Exercise

An exercise program consisting of stretching exercises, posture exercises and breathing exercises and lasting approximately 20-30 minutes will be applied to the individuals in all 3 groups.

The virtual reality group will performe virtual reality for an additional 20 minutes. (Oculus GO)
Other: virtual reality
The individuals participating in the study will experience virtual reality.
Other: exercise
The individuals participating in the study will performed neck-specific exercises.
Experimental: cervical mobilization+Exercise

An exercise program consisting of stretching exercises, posture exercises and breathing exercises and lasting approximately 20-30 minutes will be applied to the individuals in all 3 groups.

Mobilization techniques that will mobilize the cervical region will be applied to the cervical mobilization group for 20 minutes.
Other: exercise
The individuals participating in the study will performed neck-specific exercises.
Other: cervical mobilization
The individuals participating in the study will be applied cervical mobilization techniques.
Other: Control
Control group will only perform an exercise program.
Other: exercise
The individuals participating in the study will performed neck-specific exercises.

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
Time Frame: Change from Baseline balance after 4 weeks/10 sessions.
Proprioception in all cervical directions will assessed by Cervical Range of Motion device.
Change from Baseline balance after 4 weeks/10 sessions.
Baropodometer assessments- Center of gravity
Time Frame: Change from Baseline proprioception after 4 weeks/10 sessions.
Center of gravity will assess with FreeMed baropodometric platform and will record as mm.
Change from Baseline proprioception after 4 weeks/10 sessions.
Functional Balance
Time Frame: Change from Baseline proprioception after 4 weeks/10 sessions.
10 meter walking speed and four square step-test will be combined to report dynamic balance.
Change from Baseline proprioception after 4 weeks/10 sessions.
Baropodometer assessments-Pressure distribution
Time Frame: Change from Baseline proprioception after 4 weeks/10 sessions.
Pressure distribution will assess with FreeMed baropodometric platform and will record as percentage.
Change from Baseline proprioception after 4 weeks/10 sessions.
Baropodometer assessments- Oscillations
Time Frame: Change from Baseline proprioception after 4 weeks/10 sessions.
Oscillations will assess with FreeMed baropodometric platform.
Change from Baseline proprioception after 4 weeks/10 sessions.
Baropodometer assessments- Sway velocity
Time Frame: Change from Baseline proprioception after 4 weeks/10 sessions.
Sway velocity will assess with FreeMed baropodometric platform and will record as degrees.
Change from Baseline proprioception after 4 weeks/10 sessions.

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 Pain
Time Frame: Change from Baseline cervical pain after 4 weeks/ 10 sessions.
Visual Analog Scale will be used to assess this outcome measure.
Change from Baseline cervical pain after 4 weeks/ 10 sessions.
Functional disability
Time Frame: Change from Baseline functional disability after 4 weeks/ 10 sessions.
Neck Disability Index will be used to assess this outcome measure.
Change from Baseline functional disability after 4 weeks/ 10 sessions.
quality of life about cervical pain
Time Frame: Change from Baseline quality of life about cervical pain after 4 weeks/ 10 sessions.
SF-36 will be used to assess this outcome measure.
Change from Baseline quality of life about cervical pain after 4 weeks/ 10 sessions.
Global perceived effect
Time Frame: Change from Baseline Global perceived effect after 4 weeks/ 10 sessions.
Global perceived effect scale will be used to assess this outcome measure/ 10 sessions.
Change from Baseline Global perceived effect after 4 weeks/ 10 sessions.

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: Oge, Hacettepe University

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.
May 10, 2023

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.
June 1, 2023

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.
September 15, 2023

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).
March 8, 2023

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.
April 13, 2023

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.
April 25, 2023

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.
March 29, 2024

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.
March 27, 2024

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.
March 1, 2024

More Information

Terms related to this study

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.
  • VRMOB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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