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Virtual Reality and Cervical Mobilization

Primary Purpose

Neck Pain, Virtual Reality

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality
cervical mobilization
exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

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

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

virtual reality+Exercise

cervical mobilization+Exercise

Control

Arm Description

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)

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.

Control group will only perform an exercise program.

Outcomes

Primary Outcome Measures

Proprioception
Proprioception in all cervical directions will assessed by Cervical Range of Motion device.
Balance
Unilateral stance and body sway will assessed with FreeMed baropedometric platform.
Dynamic Balance
10 meter walking speed and four square step-test will be combined to report dynamic balance.

Secondary Outcome Measures

Cervical Pain
Visual Analog Scale will be used to assess this outcome measure.
Functional disability
Neck Disability Index will be used to assess this outcome measure.
quality of life about cervical pain
SF-36 will be used to assess this outcome measure.
Global perceived effect
Global perceived effect scale will be used to assess this outcome measure.

Full Information

First Posted
March 8, 2023
Last Updated
September 21, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05829564
Brief Title
Virtual Reality and Cervical Mobilization
Official Title
Comparison of the Effects of Virtual Reality and Cervical Mobilization in Individuals With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
September 15, 2023 (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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality+Exercise
Arm Type
Experimental
Arm Description
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)
Arm Title
cervical mobilization+Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
Control group will only perform an exercise program.
Intervention Type
Other
Intervention Name(s)
virtual reality
Intervention Description
The individuals participating in the study will experience virtual reality.
Intervention Type
Other
Intervention Name(s)
cervical mobilization
Intervention Description
The individuals participating in the study will be applied cervical mobilization techniques.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
The individuals participating in the study will performed neck-specific exercises.
Primary Outcome Measure Information:
Title
Proprioception
Description
Proprioception in all cervical directions will assessed by Cervical Range of Motion device.
Time Frame
Change from Baseline proprioception after 4 weeks.
Title
Balance
Description
Unilateral stance and body sway will assessed with FreeMed baropedometric platform.
Time Frame
Change from Baseline balance after 4 weeks.
Title
Dynamic Balance
Description
10 meter walking speed and four square step-test will be combined to report dynamic balance.
Time Frame
Change from Baseline dynamic balance after 4 weeks.
Secondary Outcome Measure Information:
Title
Cervical Pain
Description
Visual Analog Scale will be used to assess this outcome measure.
Time Frame
Change from Baseline cervical pain after 4 weeks.
Title
Functional disability
Description
Neck Disability Index will be used to assess this outcome measure.
Time Frame
Change from Baseline functional disability after 4 weeks.
Title
quality of life about cervical pain
Description
SF-36 will be used to assess this outcome measure.
Time Frame
Change from Baseline quality of life about cervical pain after 4 weeks.
Title
Global perceived effect
Description
Global perceived effect scale will be used to assess this outcome measure.
Time Frame
Change from Baseline Global perceived effect after 4 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oge
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Virtual Reality and Cervical Mobilization

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