NCT04014998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

July 5, 2019

Last Update Submit

June 28, 2022

Conditions

Keywords

neck painvirtual realityproprioceptionbalance

Outcome Measures

Primary Outcomes (2)

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

    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.

    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 Outcomes (9)

  • cervical lordosis angle

    Change from baseline cervical lordosis 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.

    Change from baseline quality of life 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.

    Change from baseline anxiety-depression after 6 weeks.

  • +4 more secondary outcomes

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Virtual Reality + Exercise

Other: Virtual Reality

Exercise

OTHER

Exercise Only

Other: Virtual Reality

Interventions

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.

Also known as: Exercise
ExerciseVirtual Reality

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to have pain more than 3 months,
  • to be sedentary,
  • to have Neck Disability Index score more than 10.

You may not qualify if:

  • to have neurological deficits, vestibular pathology, history of surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 28356241BACKGROUND
  • 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.

    PMID: 21779307BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Halil Kamil Öge

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Virtual Reality
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 10, 2019

Study Start

October 30, 2020

Primary Completion

September 30, 2021

Study Completion

October 10, 2021

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations